jobsthatcrossedmydesk july 15, 2012 - audrey' s networkjul 15, 2012  · each listing....

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7/15/2012 1 Jobs That Crossed My Desk Through July 15, 2012 Complimentary Service of Audreysnetwork.com July 15, 2012 If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. ********************************************************************* [email protected] Director Clinical and Regulatory Director Clinical and Regulatory Date Posted: 6/28/2012 Job Id: 1765 Company: We are a medical device company that is committed to improving the health of women worldwide by developing, manufacturing and marketing quality, high-value added medical products to prevent, diagnose and treat female reproductive system diseases. The Company is acquiring an European company with a core clinical diagnostic product line, with a focus on high-quality, low cost instrument and reagents. It is these products and revenues which, in addition to a financing, will drive the Company to significant profitability within two years. Company has all the ingredients for a successful company: a senior management and key technical team that all have over 25 years of directly-related, successful, proven experience in their functional areas; multiple, huge market opportunities –the total market opportunity for the unique women’s health products of $75 Billion outside the US; high unmet needs in the target markets to ensure rapid market acceptance; patented and proprietary technologies and products; and a profitable recurring revenue business model. The Company built its business plan to reach profitability as quickly as possible by using strategic partnerships for development and manufacturing, and distribution for sales and marketing. Location: Northern CA Reports To: CEO Salary: up to 150K. Requirements: Musts: Proven market approvals re CE (international), 510k and worked with CRO re PMA in medical device. Has worked In a early stage company. At least 7 years experience. We will only be looking for an experienced (here) clinical/quality/regulatory person who has DONE vs managed, the following: QA systems(set them up). CE and 510k/PMAs. Managed clinical trials. Can live in the greater SF area.

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Page 1: JobsThatCrossedMyDesk July 15, 2012 - Audrey' s NetworkJul 15, 2012  · each listing. Individual listings of each executive search person are separated by string of stars. Multiple

7/15/2012 1

Jobs That Crossed My Desk Through July 15, 2012 Complimentary Service of Audreysnetwork.com

July 15, 2012

If interested in a listed position, contact the person whose information appears at the top of each listing. Individual listings of each executive search person are separated by string of stars. Multiple listings submitted by one recruiter are separated by straight lines. Remember I’m not a recruiter and only distribute this listing to help bioscience industry professionals identify potential positions with contact person information provided where possible. These positions originated with individuals in my network. Jobs are materializing but with such a large pool of qualified professionals at this time, they fill up fast. Always be sure to check the website of recruiter or company to learn what jobs have popped up in between my publications. Unfortunately, I’m not able to post these every day but this tip should help you find newly posted jobs from the contacts sending the jobs below. Be sure to join the Bio2Device Group (includes professionals from all life science sectors and functions) to access their list of positions which includes different universe of jobs. You must attend one of B2DG meetings to become member but application in free. See details at www.bio2devicegroup.org. ********************************************************************* [email protected] Director Clinical and Regulatory Director Clinical and Regulatory Date Posted: 6/28/2012 Job Id: 1765 Company: We are a medical device company that is committed to improving the health of women worldwide by developing, manufacturing and marketing quality, high-value added medical products to prevent, diagnose and treat female reproductive system diseases. The Company is acquiring an European company with a core clinical diagnostic product line, with a focus on high-quality, low cost instrument and reagents. It is these products and revenues which, in addition to a financing, will drive the Company to significant profitability within two years. Company has all the ingredients for a successful company: a senior management and key technical team that all have over 25 years of directly-related, successful, proven experience in their functional areas; multiple, huge market opportunities –the total market opportunity for the unique women’s health products of $75 Billion outside the US; high unmet needs in the target markets to ensure rapid market acceptance; patented and proprietary technologies and products; and a profitable recurring revenue business model. The Company built its business plan to reach profitability as quickly as possible by using strategic partnerships for development and manufacturing, and distribution for sales and marketing. Location: Northern CA Reports To: CEO Salary: up to 150K. Requirements: Musts: Proven market approvals re CE (international), 510k and worked with CRO re PMA in medical device. Has worked In a early stage company. At least 7 years experience. We will only be looking for an experienced (here) clinical/quality/regulatory person who has DONE vs managed, the following: QA systems(set them up). CE and 510k/PMAs. Managed clinical trials. Can live in the greater SF area.

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********************************************************************* To apply for a position send your resume to [email protected] Sr Medical Writer - Full time position (San Francisco Bay area) PPB To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: This position independently develops, writes, and edits material for regulatory submission or technical and scientific publications. This position builds strong working relationships with Clinical Development, Regulatory Affairs, Preclinical, Global Safety, external collaborators and Contract Research Organizations. • Provide broad medical writing and project management support for the programs and efforts of the Clinical Development group. This is a hands-on position that entails writing and editing clinical documents for submission to regulatory authorities. • Your responsibilities include, but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, CTD clinical overviews and summaries, safety updates, and integrated summaries of safety and efficacy. • Author, co-author, update, and critically edit publications (manuscripts, review articles, abstracts, poster and presentations, etc.) in support of company programs and products. • Perform literature searches/reviews as necessary to obtain background information and training for development of documents. • Participate in electronic document publishing efforts. Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Ensures document content and style adheres to ICH/FDA/EMEA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines. • Assist in the development of departmental SOPs and guidelines. • Facilitate internal review of materials or documents and consolidate comments from internal and external reviewers or writers. • Build consensus and implement, and continually improve cross-functional processes to ensure maximum efficiency. • Build strategic relationships within Company and with business partners, vendors and key external though leaders to help facilitate involvement with writing activities. EXPERIENCE AND QUALIFICATIONS: • Strong scientific/medical/health-related background • B.A. with 8 years, M.S. with 6 years, or a M.D., Pharm.D, or Ph.D. with 5 years or more experience in the research, pharmaceutical or biotechnology industry (including postdoctoral work) • Experience must include at least 3 years of relevant medical writing industry experience and a proven track record in writing high quality regulatory documents • Experience in writing clinical and regulatory documents for oncology products is a plus but not essential • Demonstrated knowledge and understanding of business processes, regulatory, and other requirements (GCP, eCTD, ICH, etc.) for Medical Disclosures • Experience with and working knowledge of clinical trials, clinical development, biostatistics, regulatory, legal

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• Excellent organizational, project management and communication skills • Ability to analyze, interpret, and communicates data concisely • Set objectives and deliver quality results in a dynamic, fast-paced environment • Self-motivated and flexible • Expert user of Microsoft Office word processing, presentation, and spreadsheet software; Electronic Publishing software, such as Adobe Acrobat, Illustrator; proficient with scientific graphing and database software • Comfortable with computer programs and have the ability to master new programs in a limited amount of time • Desire to work in a small growing company that has an entrepreneurial mindset. ********************************************************** To apply for a position send your resume to [email protected] Director, Health Economics & Outcomes Research (Full time position, San Francisco Bay area) PPB To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: Develop and execute research strategies to proactively address health care provider and payer needs for clinical, economic and humanistic evidence (patient-reported outcomes). Position reports to the Senior Director, Epidemiology & HEOR. • Design and lead research studies of clinical trial, external patient-level, and session-level data • Internally, work closely with biostats, clinical development, and medical affairs medical directors to perform analyses in clinical trial databases. Additionally, work closely with data strategists and programming analysts to perform analyses in large claims and HCP clinical databases • Externally, partner with external research organizations and vendors on proposed analyses/projects of external patient and session-level databases • Across all data research studies (internally or externally), actively lead and collaborate to formulate hypotheses and ensure appropriate study methods and rigorous study design are being used. Evaluate, interpret, and communicate study results while ensuring quality of studies; be able to identify and discuss biases and limitations which may impact the interpretation of the data. • Design and lead research studies of external databases while partnering with external research organizations and vendors on proposed analyses/projects. Actively collaborate to ensure appropriate methods are being used, including formulating hypotheses, rigorous study design and analysis and interpretation and communication of results • Be able to generate deep insights and understanding of strategic implications of scientific work • Maintain awareness of U.S. regulations governing promotional claims for health economics, keep abreast of current changes in HEOR. • Maintain awareness of and update organization on the current state of research and literature on relevant topics. • Identify data sources which are efficient and appropriate for research questions. EXPERIENCE AND QUALIFICATIONS: • PhD in epidemiology, medical informatics, health economics, biostatistics or other related field; or MD/MPH or MD/PhD degree. • A minimum of 10 years in the pharmaceutical/biotech industry in medical affairs, epidemiology, HEOR, biostatistics, secondary market research, or consulting firms within these

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areas. • Demonstrated acumen in presenting scientific data to internal cross-functional audience, senior management and external audience required. • Experience with health economics and outcomes research. Epidemiology and/or biostatistical background a plus. • Experience with nephrology therapeutic area, especially ESA, a plus. • Demonstrated success working with and/or managing projects using patient level datasets; (dialysis patient databases a plus). • Understanding of U.S. regulations governing promotional claims for health economics • Experience and demonstrated success managing outside/contract vendors as well as collaborations with partners. • Proven negotiation, influencing and collaboration skills. • Ability to think strategically and translate strategy into action. Strategic agility and flexibility in dynamic environment crucial. ******************************************************************* Looking for Clinical Data Manager in Los Angeles, CA for 12 months contract If interested, send me resume at [email protected] Description: Bachelor's degree or professional experience (minimum of 5 years) equivalent required (Life Sciences background preferred - Pharmaceutical, Biotech and/or CRO). Clinical Data management experience required. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) required. Experience in clinical drug development within the pharmaceutical industry or related industry Required. Oncology therapeutic area experience preferred Electronic Data Capture (Medidata Rave, Inform) platforms preferred. Vendor oversight experience preferred. Team leadership experience preferred. Project management experience preferred. SAS experience preferred. Looking for Clinical Data Manager in Los Angeles, CA for 12 months contract If interested, send me resume at [email protected] Description: Bachelor's degree or professional experience (minimum of 5 years) equivalent required (Life Sciences background preferred - Pharmaceutical, Biotech and/or CRO). Clinical Data management experience required. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) required. Experience in clinical drug development within the pharmaceutical industry or related industry Required. Oncology therapeutic area experience preferred Electronic Data Capture (Medidata Rave, Inform) platforms preferred. Vendor oversight experience preferred. Team leadership experience preferred. Project management experience preferred. SAS experience preferred. ************************************************** Medical Science Liaison - remote locations - onyx http://jobvite.com/m?3uqwofwy - APPLY HERE Will be responsible for integrating scientific expertise and knowledge with brand strategies to ensure successful implementation of the Company's marketed and emerging product portfolio.

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This will be fulfilled mainly through the development of excellent working relationships with key opinion leaders and regional clinicians of influence. Apply Here recruiting.jobvite.com **************************************************** To apply: Visit http://tinyurl.com/chev9wj or www.BMRN.com Lab Systems Architect BioMarin - Novato, CA (San Francisco Bay Area) Job Description SUMMARY Responsible for design, deployment, and support of Laboratory Systems within the IT Enterprise Architecture Team. Works closely with various IT teams, Analysts, Lab users, and Vendors to assess requirements, design, procure, and implement Laboratory Computer Systems. Strong emphasis on documentation and change control in accordance with maintaining systems in a regulated environment. Researches and makes recommendations regarding hardware, software and services by analyzing vendor proposals. Administers and maintains systems by ensuring that software and hardware are maintained at levels appropriate for critical laboratory processes. Works closely with multiple teams to assure systems are qualified via proper documentation and follows established change control. This position requires knowledge in a variety of Lab applications, operating systems, network architecture, and database environments. RESPONSIBILITIES

Architect and deploy enterprise Lab applications for internal customers. Identify and recommend technical solutions for a variety of Laboratory Applications. Ensures project implementation occurs in accordance with established change control

procedures. Apply knowledge and experience to understand business challenges and opportunities

and drive new and innovative approaches to resolving them Lead and participate in technical requirements gathering and solution design sessions

with customers, partners and other technical resources of all levels. Lead and participate in project teams comprised of customers, partners, and peers as a

technical subject matter expert. Works closely with Business Analyst team and Internal IT groups to facilitate issue

resolutions. Deliver product, technology and/or solution presentations to technical and business

decision makers and engage audiences or various levels interactively. Support ongoing Production and non-production application environments, and projects.

Management of critical systems / systems processes and problem resolution /escalations of data networking and system management issues.

Measure / monitor metrics for lab applications and support processes. Research and test emerging technologies to improve delivery and efficiency in

accordance with IT Enterprise Strategy. Provides escalated technical and production support on an on-call basis.

To apply: Visit http://tinyurl.com/chev9wj or www.BMRN.com Desired Skills & Experience EDUCATION

BS/BA in related field or equivalent work experience. Industry certifications including MCITP, ITIL, PMP, and others are a plus.

EXPERIENCE 3-5 years related experience in designing, building and supporting lab systems in a

customer facing, lead role. Demonstrated ability to implement/upgrade/maintain systems within a rigorous change

control environment.

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Experience implementing enterprise solutions in a lab environment from inception to release is preferred.

Experience with the following applications: Lonza MODA, Labware LIMS, Watson LIMS, SQL*LIMS, E-Lab Notebook, Empower, SoftMax Pro, Chemstation, WinKQCL, and other lab application related software.

Familiarity with scientific instruments such as Plate Readers, HPLC/UPLC’s, KQCL’s, Chromotography Skids, Microscopes, PA’s, CE’s, UV’s, Mass Spec’s, and other industry standard instruments.

Experience working with MS SQL and Oracle database environments is strongly preferred.

Experience with application and desktop deployment tools is preferred. Experience working in an FDA or other regulated environment with validated systems is

required. Ability to demonstrate technical expertise on various scales IT projects. Experience with application performance monitoring techniques, methods and metrics is

a plus. Troubleshooting and problem solving expertise and actions to take with other cross-

functional teams (Infrastructure, Database, Application Engineers, Business Analysts) to resolve and tune Is required.

Experience with assessing and/or implementing business continuity plans related to 24/7 software systems is preferred.

Experience supporting software systems, servers, and networks within a biotech or pharmaceutical facility Is preferred.

Familiar with industry standard best practice SDLC processes and system design documentation.

Strong technical writing and verbal (presentation) skills. Ability to create complex technical diagrams using visio. Excellent communication and collaboration skills. A successful candidate must have a strong desire to work hard, improve their skills, and

broaden the scope of their role within the organization. Candidate must be a strong team player recognizing personal improvement and awards

are best achieved by making those around you successful. ******************************************************* Apply on company website Associate Director, Quality Control Coherus Biosciences - San Francisco Bay Area Job Description Title: Associate Director, Quality Control Reports to: Senior Director, Quality Assurance Location: Redwood City, California Local candidates only. No relocation will be provided for this position. Designs and manages the Coherus product release testing and stability programs, recommends product specifications, and participates in analytical laboratory vendor qualification and management to meet ICH requirements for a portfolio of biosimilar products in global development.

Write stability protocols, place with contract laboratories and manage contract laboratories

Evaluate and continuously improve QC stability systems & compliance with requirements, including new Quality systems; address compliance challenges.

Execute QC stability program, and maintain compliance with both ongoing & new regulatory requirements

Stability data review and trend analysis, including statistical analysis

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Generate stability protocols and reports, typically as Technical Registration Documents submitted for clinical trials and product licensure.

As required, evaluate data reporting tools, institute improvements Interface with the analytical team, QA, Operations and Regulatory regarding lot release

and stability indicating methods; assure qualification and validation of lot release and stability indicating methods

Evaluate existing analytical method qualification and validation packages for accuracy and compliance with current ICH and company Quality procedures

Perform deviation investigations and CAPA implementation in support of method validation projects

Travel as necessary to the company’s third party laboratories to ensure appropriate completion of stability studies

Assist the Quality team with stability vendor audits as necessary Recommend release and stability tests and strategies for developing release

specifications Desired Skills & Experience

BS/BA in chemistry, biology, or a related field is required; an advanced degree is preferred.

A minimum of 8 years in a GMP environment (pharmaceutical or biopharmaceutical industries) with at least 5 years in a QC laboratory developing product specifications and overseeing QC stability studies

A well-rounded technical background encompassing analytical methods, instrumentation, computerized systems, biology, chemistry, microbiology, statistics and/or thermodynamics is required

Familiarity with biopharmaceutical production and testing is required Ability to solve complex technical problems Familiarity with statistical analyses related to pharmaceutical / biotech drug product

stability, including statistical software programs Familiarity with cGMP and worldwide regulatory regulations and harmonization

requirements related to stability of pharmaceutical and biotech products Previous experience is preferred in QC lab or QC stability program in a pharmaceutical

or biotech environment Excellent written and communication skills, scientific report writing Strong computer skills. Proficiency in other statistical analysis software desired Must have the ability to travel domestically and internationally for periodic vendor

audits, up to 15% Company Description Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information Posted: July 13, 2012

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Type: Full-time Experience: Director Functions: Quality Assurance Industries: Biotechnology Job ID: 3384796 *********************************************************** Apply on company website at http://www.depomed.com/view.cfm/1346/Current-Openings Quality Assurance Manager Depomed, Inc. - Note: In Menlo Park but moving to Newark in December 2012. (San Francisco Bay Area) Job Description Quality Assurance Manager The QA Manager will be responsible for oversight of all quality aspects related to manufacture of commercial & clinical products at contract manufacturing organizations (CMOs). In partnership with QC, Regulatory Affairs, Technical Development and Operations, the QA Manager will ensure that products are manufactured in accordance with cGMPS, regulatory commitments and internal procedures. This position reports to the Sr. Director of QA. Essential Job Functions:

Approve master batch records, specifications, qualification & validation protocols and reports, labels

Approve/release (or reject) commercial and clinical batches Provide guidance and make recommendations regarding issues that relate to

manufacturing products in accordance with 21 CFR 211, EU regulations and current industry standards

Approve deviations, ensuring that root cause analysis and corrective actions are adequate

Audit CMOs Manage product complaints according to procedure Be familiar with establishing or optimizing quality systems Perform risk analysis to assess inadvertent events that may impact product identity,

strength, quality, purity Advise and/or manage risk management strategies Supervisory work may be required Perform due diligence assessments Author quality agreements Must be capable of working independently with minimum supervision

Additional Responsibilities and Duties: Establish/maintain effective working relationship with CMOs/business partners Partner with ‘CMC’ team members to ensure a cohesive unit aligned in expectations for

CMO deliverables Travel estimated 20%

Desired Skills & Experience Education and Experience:

Bachelor’sdegree in a scientific field Minimum 10years’ experience in GMP environment with at least 5 years QA experience Experience with manufacturing commercial pharmaceutical products a plus Experience with combination products a bonus Prior experience with outsourced GMP activity strongly desired

Skills and Abilities: Strong oral and written communication skills Ability to recognize and accommodate cultural differences in a work environment Ability to multi task

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Computer literate (word, excel, etc.) Good collaborative skills

Company Description At Depomed our employees are passionate about creating great. Since our founding in 1995 we've worked hard to create a great specialty pharmaceutical company with great products. Our expertise and hard work has led to FDA approval and commercialization of our two marketed products, Gralise and Glumetza, a pipeline with late-stage product opportunities, and the development of our Acuform™ delivery technology, a unique, patented, polymer-based technology designed to optimize drug delivery. We are currently seeking a Quality Assurance Manager to join our great team in Menlo Park. (Note: the company will be relocating to Newark in December 2012.) Depomed is an Equal Opportunity/Affirmative Action Employer. This is a direct full time hire- No agencies please. Additional Information Posted: July 13, 2012 Type: Full-time Experience: Mid-Senior level Functions: Quality Assurance Industries: Pharmaceuticals Job ID: 3384892 *********************************************************** Qualified candidates please reply to: Cindy Johnson [email protected] tel: 925-577-8135 Most Urgent Positions: Embedded Software Engineer Sr. Product Manager (based in Vancouver, WA) Staff Systems Engineer R&D, Manufacturing & Operations Roles Software Engineer (embedded)

BS in relevant science or engineering discipline 1 - 3+ years experience in embedded real time software development Software validation and testing experience is required Small team/company experience is strongly preferred Some medical device industry experience preferred (not required) C/C++ required, C# or VB a plus Experience with uC/OS – II RTOS development with Embedded Development IDEs (e.g.

IAR Embedded Workbench) Small company/team experience preferred willing to do documentation work

Software Engineer (embedded) BSEE preferred or BSCS degree Some experience in embedded real-time software development C/C++ experience preferred Small team experience strongly preferred

Sr. Software Engineer (embedded) BSEE or BSCS degree Minimum 5+ years experience in embedded real-time software development Minimum 3+ years working in the Medical Device field C/C++ experience required, Visual Basic a plus Experience with uC/OS – II RTOS development with Embedded Development IDEs (e.g.

IAR Embedded Workbench or Texas Instruments Code Composer)

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Experience with JTAG debugging Experience with GNU compilers

R&D Project Engineer BSME required, MSME preferred 3+ years experience in R&D within medical device industry Startup or small company/team experience strongly preferred Proven experience taking a project from concept to commercialization SolidWorks, catheter / implantable device experience required

Staff Systems Engineer A minimum of 7 years experience in embedded systems hardware development A minimum of 5 years working in the FDA compliant medical system Strong background and working knowledge of Electronics Design on embedded system

for medical applications. Mechanical knowledge for the system development a plus. Working knowledge of international standards for medical systems, including the

IEC60601 series Experience in medical device development from concept to commercialization

Regulatory, Quality & Clinical Affairs Director of QA, RA (timing may be closer to Q4)

BSEE or BSME, advanced degree preferred 10+ years experience in leading the QA & RA functions within the medical device

industry Medical capital equipment experience required Experience working with CMO’s strongly preferred Startup experience required

Sales, Marketing, Business Development & Customer/Product Support Sr. Product Manager (based in Vancouver, WA)

Bachelor’s degree in business or medical field with 7-10 years Product Marketing experience. M.B.A. and/or sales experience is a plus.

Medical market experience required, ideally in pain management, orthopedic, or neuro applications and confidence in interacting with physicians, and medical technologies such as ultrasound and radio frequency.

Proven track record of adaptability and ability to extend existing and develop new relationships and marketing initiatives to make them valuable and effective in our market segment.

Sr. Product Manager, New Products (could be Director level for appropriate candidates) BA, BS degree required, MBA preferred 5+ years experience in marketing within medical software and capital equipment Experience marketing medical software products is required Experience working directly with physicians and healthcare professionals on new

product and application development *********************************************************** Nektar has two openings in Drug Safety at Nektar thanks to Louise Johnson for this info. She thought she'd let us know that they have two openings in Drug Safety at Nektar - they are manager level jobs, but one may be upgraded if HR lets us. If you know of someone with excellent drug safety skills who might be interested, please let me know. One of the openings is posted at http://www.nektar.com/nektar_jobs/overview.html ***************************************************** Apply on company website

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Document Control Manager Coherus Biosciences - San Francisco Bay Area Job Description Title: Document Control Manager Reports to: Sr. Director, Quality Assurance Location: Redwood City, CA Local candidates only. No relocation will be provided. Overview: Oversees and manages the creation and ongoing administration of company documents for all of the company’s GXP related processes.

Responsible for the implementation and ongoing management of Quality procedural and recordkeeping documents

Issue Change Orders for procedural documents undergoing revision Provide support and guidance on procedural processing requirements and expectations

to authors and SMEs Manage approval processing of all procedural documents including formatting

and facilitating approval signatures with Senior Management Resolve questions regarding the Document Control processes Track and follow-up with Authors on Documents in Development (interact with all levels

in the organization) Track and follow-up with Approvers on documents routing for approval

signatures (resolve any questions) Provide monthly tracking metrics for procedural documents as requested Update/Archive/Obsolete older version of procedural documents (both electronic and

hard copies) Maintain official hard copy files (ensure all files are current and compliant

with procedures and processes) Responsible for the converting of hard copy Change Control records and Validation

records to electronic copies and filed in designated electronic locations Assist the Quality team with vendor audits as necessary Participate in document management projects as requested

Desired Skills & Experience BS/BA in life sciences or equivalent is preferred Must have 5-8 years of document control experience in a pharmaceutical

or biotechnology company Must have proven writing, proofing and editing experience Must have outstanding organizational, administrative and attention to detail skills Must have a solid knowledge and understanding of GXP SOPs Experience with vendor audits is preferable Must have great customer and client service skills Excellent interpersonal and communication skills. Strong computer skills, including all MS Office applications Must have the ability to travel domestically for periodic vendor audits, up to 15%

Company Description Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing

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the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information Posted:July 10, 2012 Type:Full-time Experience:Mid-Senior level Functions:Quality Assurance Industries:Biotechnology Job ID:3362024 ************************************************************* TO APPLY or to inquire about this opportunity, please contact Rebecca Roe directly at [email protected]. I can also be reached via phone at 925-627-4954. CMC Project Manager PharmAscent - San Francisco Bay Area (San Francisco Bay Area) Job Description PROJECT MANAGER (CMC) Location: San Francisco Bay Area Responsibilities: - Responsible for managing multiple CMC Project Teams. - Works in partnership with project leaders to ensure timely, efficient, and effective moderation of meetings, and to ensure adequate progress on team activities between meetings. - Co-Chairs CMC Project Team meetings and is responsible for coordinating team operations and communications. - Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status. - Organizes Project Management support for various functional areas on the project, attends subteam meetings and organizes ad hoc working groups. - Leads the initiation and update of Project Development Plans, which form the operational basis for the CMC team. - Ensures that Development Plans optimize the integration of timing, scope and resources. - Ensures project work compiles with established practices, policies and processes. - Collaborates with the team and functional areas to anticipate and identify project issues, which pose a challenge to achieving strategic goals, and implements plan with the team to resolve such issues and organizes team to execute on the corrective actions. Requirements: - A Bachelor’s degree and a minimum of 8 years of relevant industry experience, including 3+ years experience as a project manager, pharmaceutical line manager, or pharmaceutical functional area scientist is required. Candidates with a higher education level and less professional experience may be considered. - Experience should include participation in cross-functional project management activities. - Must have a working understanding of the drug development process. - Must be able to support multiple project teams simultaneously and be able to work in a fast paced environment. - Must possess excellent interpersonal, organizational, and written and verbal communication skills.

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- Requires in-depth knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools. - PMP certification and Lean Six Sigma experience is a plus. - Experience in Virus, Anti-infectives and Oncology is a plus. - PAI (pre-approval inspections) experience with auditing manufacturers would be helpful. *********************************************************************** Email resumes to [email protected] Senior Auditor, Quality Assurance Audit in NY and CA Must have supplier QA auditing experience as well as compliance experience. Must have solid dosage Rx pharmaceutical experience. BS or BA degree plus 4+ years of pharmaceutical auditing experience. Must be able to travel up to 20% for the NY position and up to 40% for the CA position. Perform internal and external audits for the QA Compliance department. Internal audits will consist of production systems manufacturing and analytical departments. External audits will consist of contract manufacturers, API suppliers, excipient suppliers, contract laboratories, and other suppliers used in the manufacture of drug products. Schedule, perform, document, write reports, make observations and follow up on audits of domestic and foreign suppliers of active pharmaceutical ingredients, excipient materials, packaging components, contract service providers including testing laboratories, engineering, technical or regulatory service providers as well as contract manufacturing service providers that are being used or considered for use as processors or packagers of drug product. Schedule, perform, document, write reports, make observations and follow up on audits of domestic and foreign contract manufacturing service providers that are being used or considered for use as processors or packagers of drug product. REQUIRES: A minimum education resulting in a Bachelor’s Degree in Chemistry, Pharmaceuticals, Biology or a related science or engineering. A minimum of five years in regulatory compliance, quality assurance or quality control laboratory experience in the pharmaceutical industry. Experience auditing manufacturing facilities, equipment, laboratories and service providers. A working knowledge of pharmaceutical manufacturing processes. A working knowledge of pharmaceutical testing laboratory procedures and instruments An intimate knowledge of the current Good Manufacturing Practices as defined in the Code of Federal Regulations by the U.S. Food and Drug Administration and the ability to apply that knowledge to assure that providers of materials and services are compliant. Excellent verbal and written and organizational skills. The position requires that the employee communicate with internal and external management groups in order to assure that non compliant conditions noted during audits are addressed. Ability to hold and maintain a valid driver license and passport. Ability to get Visa required for travel to foreign audit sites. Ability to perform audits in industrial or laboratory settings. Ability to travel for up to two weeks at a time both foreign or domestically (travel is approximately 15% of time) SR. COMPLIANCE SPECIALIST, CA - SOUTHERN Provide support to the Compliance department and ensure compliance with cGMP and company policies, procedures and specifications. Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. · Conduct and coordinate internal audit and audit result reporting. · Conduct and coordinate external audit: Qualification for suppliers, GMP service provider, contract lab,

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· Follow up on audit response commitment · Responsible for the maintenance and update of qualification for suppliers, GMP service providers, contract labs, etc. · Assist during regulatory, corporate and customer inspections. · Provide assistance with the Complaint handling system · Provide assistance in conducting GMP training (globally). REQUIRES: · Working knowledge of the 21 CFR Part 210 and 211, GDP and GMP. 30-40% travel both domestic and international is required. Bachelor’s Degree in Chemistry with 3-5 year ************************************************************************* Interested or know someone who is looking for new job opportunity, please contact [email protected] or call me directly at 732-276-9940 Ext: 208 Local Trial Manager III - San Francisco, CA Duration: 06+ months Contract Qualification: • 4 Year College Degree (Bachelors) required with 10+ years of related experience. • Experience managing clinical vendors, especially CROs • Prior clinical site monitoring experience, International Trial Experience, Experience managing a CRO, Experience with EDC. *************************************************************************** For additional information please email me your resume at [email protected] “Clinical Data Manager III” – 12+ months contract in Los Angeles, CA (US based candidates only) Requires minimum of Bachelor degree with 5 years of industry experience in clinical data-management (Life Sciences background preferred - Pharmaceutical, Biotech and/or CRO). In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) required. Experience in clinical drug development within the pharmaceutical industry or related industry Required. Oncology therapeutic area experience preferred. Electronic Data Capture (Medidata Rave, Inform) platforms preferred. Strong vendor oversight, team leadership and project management experience is required. SAS Experience preferred. ****************************************************************************** Apply Here - http://jobvite.com/m?3xvmofww Summary The successful candidate, reporting to the Associate Director of Global Publications Planning in Scientific Affairs, will be responsible for writing, reviewing and editing scientific and clinical, peer reviewed manuscripts, abstracts, posters, oral presentations and reviews in support of Onyx products. This position will work in collaboration with the Onyx Global Publication Teams and external medical writing agencies, liaising with key internal and external stakeholders to ensure the seamless development and execution of publications. The role may include managing existing publication plans, leading and developing strategies and corresponding publications for future plans. Senior Medical Writer & Publications Planner | South San Francisco, California hire.jobvite.com Summary The successful candidate, reporting to the Associate Director of Global Publications Planning in Scientific Affairs, will be responsible for writing, reviewing and editing scientific and clinical, peer reviewed manuscripts, abstracts, posters, oral presentations and reviews in

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support of Onyx products. This position will work in collaboration with the Onyx Global Publication Teams and e ************************************************************************* . Please send resumes to [email protected] with subject line ‘Principia Cell Biologist.' Senior Research Associate/Research Scientist in Cell Biology Principia Biopharma Senior Research Associate/Research Scientist in Cell Biology Principia Biopharma Principia Biopharma is a biotechnology company located in South San Francisco that is utilizing its reversible covalent platform to design and develop new small molecule drugs. Currently we are seeking a cell biologist who will primarily be responsible for developing and utilizing a variety of cellular assays to characterize our inhibitors. Requirements We are looking for a candidate with either a B.S./M.S. degree and 7+ years of relevant industry experience or a Ph.D. degree and relevant postdoctoral experience. The candidate should have a broad knowledge of different signaling pathways and the methodologies used to interrogate them. Highly recommended technical skills include cell culture, Western blotting, ELISAs, cell viability and toxicity assays, Luminex or MSD, Alpha technology, luminescent and fluorescent assays, and related methods. Candidates should be well-versed in analysis software such as Excel or Prism and also in the fitting of dose-response data. It is desirable that the candidate has experience with varied cell types and multiple signaling pathways in the oncology and/or inflammation disease areas. The successful candidate will be highly self-motivated and also able to work closely with other team members to provide key information to drive our programs. Principia provides an exciting work environment and an opportunity to work with a highly experienced drug discovery teams EOE San Francisco ***************************************************************************** Contact: Send a resume to be considered. Jonathan M. Guidi President HealthCare Recruiters International 220 Montgomery St. #1614 San Francisco, CA 94104 p: 415-773-0333 x13 f: 415-276-9058 [email protected] www.hcrjobs.com Marketing Director Emeryville, CA Share:EmailTwitterFacebookLinkedIn Location Emeryville, CA Salary/Pay Rate 140k + equity

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Employment Type Full Time Job Description Cutting edge medical technology/equipment start-up is looking for someone who wants to make a difference in the world and work with passionate people. ************************************************************************** GCP Compliance Consultant $80-100/hour Real Staffing Group - San Francisco Bay Area Contract Telephone: +1 415 796 8050 Contract Fax: +1 415 796 8099 Permanent Telephone: +1 415 796 8000 Permanent Fax: +1 415 796 8099 Permanent Email: [email protected] Job Description GCP Quality Control (QC) Consultant A pharmaceutical company in the San Francisco bay area Peninsula is looking for a GCP Quality Control Consultant to join their team for a 2 year contract. This is a 40 hr/wk position working with a small, start-up with company with an exciting pipeline. The Clinical QC Lead will have the following responsibilities and roles:

SOPs – needs assessment, drafting, revising, training and implementing version controls

Oversight and accountability for the Clinical Department to comply with internal SOPs and provide documentation of compliance

Establish a robust documentation system (hard and soft versions) to ensure clinical development and operations programs and documentation including SOPs and plans fully meet and satisfy the Quality Assurance Department, FDA and any partner directed audits of Clinical Department activities

Serve as Clinical interface with the Quality Assurance Group for all GCP internal and external audits (in process and close outs). Manage Vendors/Investigators to ensure that findings from QA audits are adequately addressed in a timely manner.

Some travel is required to key clinical vendor sites and clinical research sites to ensure appropriate SOPs are in place to complement SOPs, transfer of obligations and meet quality standards. In addition to assessment of key clinical vendor SOPs, GCP QC consultant will work closely with key vendors to ensure appropriate documentation of controlled activities are in place and to assist in rectifying any identified deficiencies in documentation or SOPs.

Advises Clinical Team of issues concerning the quality, conduct and documentation of clinical studies

Desired Skills & Experience GCP Quality Control (QC) Requirements:

Minimum BS or equivalent and minimum 10 years clinical research experience in a pharmaceutical/biotech company working within a clinical quality control/ quality assurance department.

Proven ability to work effectively independently and remotely Effective communication and leadership skills critical to achievement of QC goals Good working knowledge of clinical development software (IWRS, EDC, MS Office etc.) Familiarity with an outsourced clinical trial model Ability to represent the company effectively with CRO and key external vendors Excellent documentation skills and systems design

Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a

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wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted: July 10, 2012 Type: Contract Experience: Mid-Senior level Functions: Quality Assurance Industries: Pharmaceuticals Job ID: 3357002 _______________________________________________________________ GCP Quality Control (QC) Consultant Real Staffing Group - San Francisco Penninsula (San Francisco Bay Area) Job Description GCP Quality Control (QC) Consultant A pharmaceutical company in the San Francisco bay area Peninsula is looking for a GCP Quality Control Consultant to join their team for a 2 year contract. This is a 40 hr/wk position working with a small, start-up with company with an exciting pipeline. The Clinical QC Lead will have the following responsibilities and roles:

SOPs – needs assessment, drafting, revising, training and implementing version controls

Oversight and accountability for the Clinical Department to comply with internal SOPs and provide documentation of compliance

Establish a robust documentation system (hard and soft versions) to ensure clinical development and operations programs and documentation including SOPs and plans fully meet and satisfy the Quality Assurance Department, FDA and any partner directed audits of Clinical Department activities

Serve as Clinical interface with the Quality Assurance Group for all GCP internal and external audits (in process and close outs). Manage Vendors/Investigators to ensure that findings from QA audits are adequately addressed in a timely manner.

Some travel is required to key clinical vendor sites and clinical research sites to ensure appropriate SOPs are in place to complement SOPs, transfer of obligations and meet quality standards. In addition to assessment of key clinical vendor SOPs, GCP QC consultant will work closely with key vendors to ensure appropriate documentation of controlled activities are in place and to assist in rectifying any identified deficiencies in documentation or SOPs.

Advises Clinical Team of issues concerning the quality, conduct and documentation of clinical studies

Desired Skills & Experience GCP Quality Control (QC) Requirements:

Minimum BS or equivalent and minimum 10 years clinical research experience in a pharmaceutical/biotech company working within a clinical quality control/ quality assurance department.

Proven ability to work effectively independently and remotely

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Effective communication and leadership skills critical to achievement of QC goals Good working knowledge of clinical development software (IWRS, EDC, MS Office etc.) Familiarity with an outsourced clinical trial model Ability to represent the company effectively with CRO and key external vendors Excellent documentation skills and systems design

To apply to this position, please respond to this job posting as soon as possible with an updated version of your resume. Company Description Real Staffing (formerly Real Resourcing) is an international recruitment company, providing precision staffing solutions since 1998. Working with a range of businesses across the globe, we offer talented professionals outstanding career opportunities. In the UK we're covering a wide range of sectors: - Banking and Finance - Healthcare - IT - Pharma - Public Sector Whereas our offices in France, Germany, the Netherlands, Australia and the US specialised in the Pharma sector. Real Pharma A global business sector requires a global consultancy. With issues such as professional ethics, product development and the safety of the public at its heart, the pharma and biotech industry requires personnel who can navigate big picture trends while focusing on the most sensitive details. It is a demanding employment market – and time and again, we are able to meet those demands. Our approach In a sector with exacting skills parameters, we source quality personnel for hardtofill, niche roles. This focus is only possible in a multinational company with experienced, motivated consultants. As the whole industry hinges on lengthy product cycles, we believe in building long term client relationships based around long term commitments. We have the tenacity to follow the sector’s longer consultative and decision making processes and deliver results. Additional Information Posted: July 9, 2012 Type: Contract Experience: Mid-Senior level Functions: Quality Assurance, Science, Manufacturing Industries: Pharmaceuticals, Biotechnology Job ID: 3356527 ********************************************************************* To apply for this position, send your resume to [email protected]. EOE Department: Business Development Job Title: Lead, Business Developer Job Location: San Francisco, CA Description: The Business Development Lead will be responsible for successfully driving new and existing web applications and platform solutions within the life sciences communications space. This position will report directly to the President and General Manager. Zoomedia has developed a five year growth plan to increase revenues threefold with this individual leading the charge. As Zoomedia grows, this person will have the opportunity based on performance to build an internal team and manage the business development efforts. Responsibilities: The successful candidate will be required to:

Become an expert in the company's offerings and capabilities as they relate to the life sciences market and the associated regulatory environment

Identify, meet and close deals with decision makers Respond to RFPs and write proposals Ability to work across teams within the organization

Required Skills: Must have a clear track record of excellence in several categories, including:

A strong track record of closing sales

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Experience developing trusted relationships with senior executives Exceptional communication skills (verbal and written) Proven ability to communicate with senior management, C Suite Executives

Job Requirements: QUALIFICATIONS: Seeking bright, positive, flexible candidate who has:

A minimum of five plus years’ experience in sales/marketing within the life science space (Experience in a healthcare communication agency highly preferred)

Act with the highest integrity and professionalism in all endeavors Willingness to take risks and overcome failures A self-starter, committed to successfully growing a business Ability and initiative to handle increasing responsibility over time

Opportunity: Zoomedia offers a competitive base compensation, profit sharing, and benefits package and are committed to fostering a culture that encourages innovation, creativity, collaboration amongst staff and rewards accordingly. *********************************************************************** Apply on company website Sr. Product Manager, Payer Promotional, MC Marketing Genentech - South San Francisco, CA (San Francisco Bay Area) Job Description Who We Are At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work. The Position Sr. Product Manager Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics for the assigned managed care segments in the U.S. and related territories. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management in the assigned managed care segments and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned. · Plays a key role in development and delivery of the Genentech & Product Value Proposition · Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech - formulary positioning, reimbursement, access and overall market share · Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives for assigned segments · Reviews and assesses cross-functional business strategies, plans and tactics; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share ·

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Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results · Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics for assigned managed care segments · Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives · Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans · Collects customer insights through advisory boards, strategic councils and focus groups, develops key portfolio resources for MCCO (Managed Care & Customer Operations) field such as disease state/product marketing materials, B2B strategic talking points, eMarketing planning and execution, and training the MCCO field in all such tools · Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence · Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc. · Provides strategic consultation to brands and MCCO groups regarding key brand market events · Creates appropriate marketing budgets by working with peers, manager and/or other internal partners · Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility · Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments · Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives · Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position · Complies with all laws, regulations and policies that govern the conduct of GNE activities Who You Are Bachelors Degree · MBA or other related graduate-level degree is preferred · Average of 4 or more years’ work experience · An average of 2 years’ previous marketing experience in the pharmaceutical, biotechnology, or related industry · Previous, direct managed care experience – marketing, strategy, account management, or other roles – is preferred · Previous marketing experience in the same or related therapeutic area is a plus · Previous market research, analysis, planning experience in the pharmaceutical, biotechnology, or related industry is a plus · Previous pharmaceutical, biotechnology, or related field sales or field sales management experience is preferred · Proven track record for consistently meeting or exceeding financial and/or other quantitative targets, as well as qualitative goals · Previous experience in completing and implementing attainable business plans · Business travel, by air or car, is required for regular internal and external business meetings Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply. Additional Information Posted: July 5, 2012 Type: Full-time Experience: Associate Functions: Marketing, Sales

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Industries: Biotechnology, Pharmaceuticals Employer Job ID: 00385224 Job ID: 3336808 *********************************************************************

Jobs That Crossed My Desk Through July 8, 2012 ********************************************************************** http://www.coherus.com/jobs/ Technology Transfer Engineer Coherus Biosciences - Redwood City, California (San Francisco Bay Area) Job Description Position: Technology Transfer Engineer Reports to: Senior Vice President, Process Sciences Location: Redwood City, California The Technology Transfer Engineer will be responsible for process development, process transfer, troubleshooting manufacturing issues, scaling up biopharmaceutical manufacturing processes, process characterization and process and equipment validation activities. Develop and manage project scopes for partners and consultants in the support of project and process implementation. Ensures all Process Engineering documentation deliverables are generated. May be asked to develop new processes or optimize existing ones.

Design and vet experiments, analyze and summarize data, author technical reports, define and implement recommendations for process optimization.

Assist in the development of manufacturing documentation such as process descriptions, batch records and SOPs.

Support feasibility assessments of additional manufacturing projects and partners for capabilities such as automation, equipment, GMP facility, process enhancement, and general requirements for scale-up and commercial manufacturing.

Work in collaboration with manufacturing partners to define process requirements to meet clinical and commercial needs

Use design of experiments techniques, mechanistic modeling and basic statistical methods to analyze data and communicate results, conclusions, and recommendations.

Monitor and communicate task status for project/program success. Work with marketing partners as required to transfer processes, design, construct, and

start-up manufacturing facilities. Participate in design reviews, product and process FMEAs and related drug development

risk management processes. Travel as required to manufacturing sites located throughout the world

Desired Skills & Experience BS degree in Chemical / Manufacturing Engineering or equivalent experience. MS/PhD is

preferred Minimum 5 years of experience in biotech/pharmaceutical industry required. Experience

in drug development required including CMC preparation for regulatory filings Experienced in process development and scale up through process validation and

technology transfer Detailed knowledge of cGMP requirements and application Proven ability to work collaboratively with all levels to meet project deliverables Must operate with a high degree of autonomy and professionalism Must be innovative, technical, resourceful and well organized Must communicate in a timely and accurate manner to ensure project participants are

fully informed of project status, action items and deliverables Demonstrated ability to be flexible and maintain a professional attitude when priorities

change

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Demonstrated ability to work in a fast paced, start-up environment Ability to travel domestically and internationally, up to 25% and for short term

assignments (3 months) up to 50%. Excellent interpersonal and communication skills. Strong computer skills, including all MS Office applications and MS Project.

Company Description Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information\ Posted: July 6, 2012 Type: Full-time Experience: Mid-Senior level Functions: Manufacturing Industries: Biotechnology Job ID: 3347782 **************************************************************************** Vicki Russell Senior Technical Recruiter TechPros Recruiting [email protected] www.techprosjobs.com Manager – Medical Equipment Cleveland, OH Base Salary - $95,000 - $125,000 Full Benefits Relocation Assistance Candidates must have current and future unrestricted US work authorization. No visas. WHAT YOU’LL NEED - -Bachelor's DEGREE or equivalent in a technical discipline. -15 years' experience in a HIGH-TECHNOLOGY company, with MEDICAL EQUIPMENT experience. Multi-modality medical device industry experiences a plus. -5+ progressive years of functional and PROGRAM MANAGEMENT experience required (7+ years project & program combination) in a matrix environment, across multiple sites through the entire product lifecycle (Concept/Approval - Retirement). Experience preferably in a regulated/process-oriented environment such as medical device development.

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-Demonstrated knowledge of and proficiency in program management TOOLS (including computer-based tools) and PROCEDURES for setting and tracking performance, quality, time and cost. -Strong people management skills, including leadership, conflict resolution, assertiveness, negotiation and influence management. -Ability to TRAVEL internationally -Professional Project Management certification (considered a plus). -Strong technical skills and broad background; with the ability to drill down and question activities and issues in all functional areas. -Strong presentation skills, appropriate to both management and customer audiences. -Strong attention to detail and follow-through skills. WHAT YOU’LL DO - The Product Program Manager works in a complex, matrixed, cross-functional organization with multiple international operations and locations. The Program manager is responsible to lead the cross-functional PRODUCT DEVELOPMENT team to successfully plan, execute, and deliver programs that meet the organization's established goals for quality, cost, functionality and time to market with full regulatory compliance. -Lead the cross functional core team through the Product Realization Process milestones. -Own the program scope. Provide strong configuration control and ensure change requests are well planned, fully documented, and approved -Lead the team in the overall program planning, and execution. Establish strong operating mechanisms to track progress, identify issues, overcome obstacles, and define recovery plans. -Work with cross-functional leaders (Marketing, Operations, Sourcing, Applications Training, and Customer Support) to ensure smooth transition from every stage of the program from concept definition, development, verification/validation, design transfer to operations, and transition to installed base support. -Provide ongoing status reports to the business leadership team. -Work with Quality and Regulatory to ensure the program is fully compliant with the CT Quality System, FDA design controls, and global regulatory agency requirements. ******************************************************************************** Apply at company website Research Associate - Analytical Protein Chemistry Coherus Biosciences - Camarillo, California (Greater Los Angeles Area) Job Description Position: Research Associate Location: Camarillo, California Reports to: Research Scientist No relocation will be provided for this position. The Research Associate work as part of the team to develop/validate analytical methods and maintain analytical instrumentation. Responsible for performing research and development experiments for projects and products in collaboration with others.

Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.

Investigate, create and develop new methods and technologies for project advancement.

Regularly exercise technical discretion in design, execution and interpretation of experiments that contribute to project goals.

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Contribute to project process within scientific discipline through innovative research. He or she maintains laboratory notebooks, prepares technical reports, summaries, protocols and quantitative analyses.

Participate in scientific conferences and make contributions to publications. Desired Skills & Experience

Requires a Bachelor’s degree in chemistry, biology, or biochemistry Requires 3 - 6 years of experience in a biopharmaceutical laboratory environment Requires a full understanding of and ability to apply established principles, theories and

concepts in area of responsibility, together with a working knowledge of related disciplines.

Requires familiarity with current scientific literature together with capability to select methods and techniques for obtaining solutions within broadly defined practices and procedures.

Excellent interpersonal and communication skills. Strong computer skills, including all MS Office applications.

Company Description Coherus Biosciences is an emerging biopharmaceutical company headquartered in the San Francisco Bay Area with an entirely new model for developing safe, high-quality biosimilar therapeutics. Founded in 2010, Coherus already has formed global partnerships with top-tier pharma and filled the pipeline with five biologics that promise to be blockbusters in treating oncology and inflammatory diseases. Led by an elite group of biotech pioneers, Coherus is now reinventing the entire business of developing biologic medicines, from concept to commercialization, so that more people around the world can have greater access to quality therapeutics. Every member of the Coherus team is an expert in their field, dedicated, motivated and passionate about expanding access to life-saving therapeutics. We are committed to meeting the highest standards, inspiring our teammates and achieving our goals. Coherus offers a comprehensive compensation package including salary, stock and benefits. Additional Information Posted: July 5, 2012 Type: Full-time Experience: Associate Functions: Science Industries: Biotechnology Job ID: 3339840 ********************************************************************** Contact me to learn more about this exciting opportunit Rob Hockersmith, VP of Quality & Engineering Recruitment Device/Diagnostic/Pharma [email protected] Sr Supplier Quality Engineer - Medical Devices Sr Supplier Quality Engineer - Medical Devices - My client has been named one of the top five world class organizations and they are expanding! Qualifications: -5+ years of Medical Device Supplier Quality experience. -Bachelors in Engineering -Proficient with Process validations, CAPA investigations, Process improvement, Supplier Management, and Project Management. -ASQ certification and extrusion molding experience preferred.

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*************************************************************************** www.iconplc.com/ CRA II, Sr. CRA and Clinical Project Manager needed! ICON plc - Oakland, CA (San Francisco Bay Area) Job Description CRA II Home-based candidates in the bay area will be considered! These are long term contracts (2 year and 4 year study). The Role and your Responsibilities

Assist in managing clinical studies Plan, implement, motivate, co-monitor, manage, and track clinical trials Assist in the supervision of field monitors, CROs Establish effective relationships with clinical investigators and staff, CROs, and vendors Participate in design/development of clinical trial protocols and preparation of clinical

study/annual reports Work with data management to identify and resolve data discrepancies.

What is Required 5+ years sponsor side Pharma clinical development experience. Strong global

experience essential. Excellent vendor management and PM skills. RN desired. Travel - up to15% domestic and global Bachelor’s degrees are required, preferably in a scientific discipline. Long-term

commitments (2 and 4 year studies) Global Trial experience in multiple regions (outside of North America) managing

international multi-faceted trials Study Start Up and Close out is essential as well as details on Study Lead exp. and

most recent study start up and phase(s)/details. In-house Sr. CRA The Role and your Responsibilities

Assist in managing clinical studies Plan, implement, motivate, co-monitor, manage and track clinical trials Assist in the supervision of field monitors, CROs Establish effective relationships with clinical investigators and staff, CROs and vendors Participate in design/development of clinical trial protocols and preparation of clinical

study/annual reports Work with data management to identify and resolve data discrepancies

What is Required Bachelor’s degrees required, preferably in a scientific discipline 5+ years sponsor side Pharmaceutical clinical development experience Strong global trial experience in multiple regions essential (outside of North America)

managing international multi-faceted trials Study Start Up and Close-Out is essential as well as details on Study Lead experience

and most recent study start up and phase(s)/details Excellent vendor management and PM skills, RN desired Travel – up to15% (domestic and global) On-site requirement (Oakland/Lake Merritt location) – 5 day weekly commitment is

required and working 8 – 5PM is essential Able to make a long-term commitment (2 and 4 year studies)

Clinical Project Manager (in-house) The Role and your Responsibilities

Manage all aspects of global clinical studies to ensure delivery of milestones with regard to clinical studies: completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

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Provide leadership and guidance, global clinical trial management expertise and direction to in-house study team to ensure process consistency and knowledge sharing.

Manage and coordinate activities of Contract Research Organizations and other 3rd party vendors.

Analyze/report safety issues, patient care issues, and study design and/or study conduct issues.

Develop/direct clinical monitoring plans, study management plans and direct study monitoring priorities.

What is Required Infectious Disease, ICU/critical care experience would be helpful but not required Bachelor's degree in a scientific discipline. Nine or more years experience in clinical development and the management of clinical

trials; five years of global trial experience; Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential. Demonstrated proficiency in the implementation, monitoring and management of

clinical trials. Clear and concise verbal and written communication skills. Strong organizational skills, with an exceptional attention to detail. Must be able to work onsite Travel required

Desired Skills & Experience What is Offered DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients. We offer competitive hourly rate, comprehensive benefits including paid days off, 401K and health insurance. ICON Clinical Research is an Equal Opportunity Employer committed to strength in diversity. Company Description ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies. In a highly fragmented industry, we are one of a small group of organisations with the capability and expertise to conduct clinical trials and development projects on either a local or global basis. We have the operational flexibility to provide development services on a stand-alone basis or as part of an integrated “full service” solution. We are also an 'end-to-end' Pharmacovigilance service provider and this includes Post Marketing Surveillance activities too. Additional Information Posted: June 13, 2012 Type: Full-time Experience: Mid-Senior level Functions: Research Industries: Biotechnology Job ID: 2882614 ***************************************************************************

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Please send your CV to: [email protected] Director/Senior Director Bio-Process Development (San Francisco Bay Area) - fulltime permanent Requirement: ·M.S. or Ph.D. degree from a reputable university/institute, majoring in one or more of biological sciences, chemistry, biochemistry, or engineering. ·At least 3 years of experience in process development of therapeutic biologics (i.e. recombinant proteins or antibodies). ·Technical expertise in cell culture process development with bioreactor systems. ·Experience in bio-process scale-up and technology transfer. ·Experience in managing a technical team and project. ·Familiar with GMP requirements and FDA/EMEA/ICH regulatory guidelines. ·Fluent in Mandarin. ·Excellent work ethics and communication skills. _________________________________________________________ Please send your CV to: [email protected] Director / Senior Scientist, Molecular/Cellular Biology (San Francisco bay Area) - fulltime permanent We are seeking an experienced and highly motivated molecular/cell biologist to work independently and to lead a matrix team contributing to research programs in drug discovery and product development. He/She will be responsible for running all research projects from initial proposal, evaluation, execution, towards preclinical development at our Fremont site and coordinating operations at our Taiwan and Shanghai sites. Requirements · Ph.D. in Molecular/Cellular Biology · Experience in antibody discovery and/or with biosimilar/biobetter antibodies in industry is a plus. · High attention to details, excellent organizational and managerial skills and the ability to work on multiple projects with tight deadlines. · Excellent interpersonal and verbal communications skills and the ability to deal effectively with a variety of personnel both internally and outside the company. · Experience in animal model studies is desirable for additional responsibilities in Shanghai, China. · Willing to communicate with people from different locations at different time zones and to travel from time to time. · It is a must-have that the candidate speaks Mandarin. ********************************************************** Jack Marsh Executive Search Consultant TSG Executive Search- www.tsgsearch.com Executive Level Finance Email: [email protected] VP OF SALES & MARKETING I am searching for 2 VP OF SALES & MARKETING positions with PE comps in CA. & PA. Seeking DOD experience for 1 of the positions. Base comp of $180-$200 w/ bonus and equity. May I send a full JD to your email for review & distribution? You may send your CV to my email address for my review. ********************************************************** For additional information please email me your resume at [email protected]

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“Clinical Program Manager” – 6+ months contract in San Francisco, CA (all work to be performed onsite) – US based candidates only. Minimum of Bachelor degree in related field with 8+ years of clinical trial management experience. Be responsible for clinical trial planning and execution of a given clinical trial program. Ensure that clinical trials in a given program are conducted per ICH/GCP and regulatory compliance. Serves as primary clinical operations contact for trial management of a particular clinical program, depending on size and complexity of the program. Overall responsibility for clinical trial timelines and budgets. Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals. Responsible for cross-function management and logistical deliverables, including integration of activities from Clinical Development, Regulatory, GPRM, DM, Biometrics, Clinical Supplies, QA to lead to successful study conduct. Leads oversight of trial risk mitigation activities. Lead global vendor management and be accountable for vendor oversight plans for clinical trials. Accountable for ongoing vendor oversight (e.g. CROs, IVRS, Imaging) including escalation and management of initial SOW, budgets, vendor performance management, issue resolution and issue escalation. Maintain process instruction documents, study documents and manage protocol amendments. ********************************************************* Please send your CV to: [email protected] Urgent: Principal Scientist (Davis, CA - Sacramento Area) - fulltime permanent Desired Skills & Experience • Ph.D. degree in Formulation Science, Pharmaceutical Science, Polymer Science, Colloid and Surface Science, Organic Chemistry or related field with a minimum of 10 years of relevant industrial work experience, and a minimum 5 years of supervisory experience in industry. • Desirable experience in development of bench scale and manufacturing scale agricultural or pharmaceutical formulations. • High level expertise in aqueous solution chemistry with complete knowledge of pH, buffers, rheology, and phase transitions. • Desirable experience with colloids, surface science, microbial derived-products, plant-derived products, biopesticides and dehydration technologies. • Experience in carrying out of the following procedures is desirable: rheometry, particle size analysis, gravimetric analysis, microscopy, sieving, blending/mixing, wet/dry milling, coating, extrusion, lyophilization, spray drying and drum drying. • Understands performance and ingredient requirements of regulated agricultural and household use pesticide products in North America and the European Community. • Must have expertise in regulations concerning product ingredients including US EPA, FDA, and USDA. • Experience in technical transfer of formulation process to contract manufacturing facilities. **************************************************************************** Please send your resume at [email protected] Looking for 5-Mechanical Engineers (Medical Devices to Consumer Electronics), Project Manager (PMP) Intanna Labs Corporation, Milpitas is product engineering and contract R & D firm. Intanna is looking for 5-mechanical engineers. For local bay area, Silicon Valley- California candidate only. Design of mechanism Solidworks skills

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Converting concept sketches to mass production launch Excellent in sheet-metal, machined and injection molded part design *************************************************************************** FOR A COMPLETE JOB DESCRIPTION AND TO APPLY ONLINE: http://jobsearch.covance.com/31491-jobs.aspx COVANCE – CLINICAL PROJECT DIRECTORS with PERIAPPROVAL (PHASE IV) experience needed nationwide (home-based). To be considered, apply online: http://jobsearch.covance.com/31491-jobs.aspx CLINICAL PROJECT DIRECTORS - Periapproval (Phase IV) Bachelors Degree (prefer Life Sciences) Clinical Research Associate Experience 8+ years of GLOBAL Clinical Project Management Experience including Phase IV Experience handling financials and working with budgets in excess of $5 MM. Knowledge of business development and playing a role in the bid defense process Comfortable managing teams in a matrix environment Heavy client interaction CRO experience a plus If the link does not work - go to www.covancecareers.com and search 31491. **Must be authorized to work in the US for any employer. *************************************************************************** For additional information please email me your resume at [email protected] or call 732-494-2005, x11 "Clinical Data Manager III" - 12+ months contract in Los Angeles, CA (all work to be performed onsite) - US based candidates only Required minimum of Bachelor degree in Life Sciences or equivalent with 5+ years of global clinical data management experience. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) required. Experience in clinical drug development within the pharmaceutical industry or related industry Required. Oncology therapeutic area experience preferred. Electronic Data Capture (Medidata Rave, Inform) platforms preferred. Vendor oversight and leadership experience preferred. Project management experience required. SAS experience preferred. ********************************************************** To apply for a position send your resume to [email protected] Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Sr Medical Writer - Full time position (San Francisco Bay area) To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: This position independently develops, writes, and edits material for regulatory submission or technical and scientific publications. This position builds strong working relationships with Clinical Development, Regulatory Affairs, Preclinical, Global Safety, external collaborators and Contract Research Organizations.

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• Provide broad medical writing and project management support for the programs and efforts of the Clinical Development group. This is a hands-on position that entails writing and editing clinical documents for submission to regulatory authorities. • Your responsibilities include, but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, CTD clinical overviews and summaries, safety updates, and integrated summaries of safety and efficacy. • Author, co-author, update, and critically edit publications (manuscripts, review articles, abstracts, poster and presentations, etc.) in support of company programs and products. • Perform literature searches/reviews as necessary to obtain background information and training for development of documents. • Participate in electronic document publishing efforts. Initiate and manage development of formats, templates and general guidelines for clinical documentation and workflow procedures. Ensures document content and style adheres to ICH/FDA/EMEA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines. • Assist in the development of departmental SOPs and guidelines. • Facilitate internal review of materials or documents and consolidate comments from internal and external reviewers or writers. • Build consensus and implement, and continually improve cross-functional processes to ensure maximum efficiency. • Build strategic relationships within Company and with business partners, vendors and key external though leaders to help facilitate involvement with writing activities. EXPERIENCE AND QUALIFICATIONS: • Strong scientific/medical/health-related background • B.A. with 8 years, M.S. with 6 years, or a M.D., Pharm.D, or Ph.D. with 5 years or more experience in the research, pharmaceutical or biotechnology industry (including postdoctoral work) • Experience must include at least 3 years of relevant medical writing industry experience and a proven track record in writing high quality regulatory documents • Experience in writing clinical and regulatory documents for oncology products is a plus but not essential • Demonstrated knowledge and understanding of business processes, regulatory, and other requirements (GCP, eCTD, ICH, etc.) for Medical Disclosures • Experience with and working knowledge of clinical trials, clinical development, biostatistics, regulatory, legal • Excellent organizational, project management and communication skills • Ability to analyze, interpret, and communicates data concisely • Set objectives and deliver quality results in a dynamic, fast-paced environment • Self-motivated and flexible • Expert user of Microsoft Office word processing, presentation, and spreadsheet software; Electronic Publishing software, such as Adobe Acrobat, Illustrator; proficient with scientific graphing and database software • Comfortable with computer programs and have the ability to master new programs in a limited amount of time • Desire to work in a small growing company that has an entrepreneurial mindset. ************************************************************** For additional information please email me your resume at [email protected] or call 732-494-2005, x115. Thank you in advance!

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“Sr. Product Vigilance Scientist” – 6+ months contract in San Francisco, CA (US based candidates only) Required minimum of a Bachelors degree in related field with 4-6 years of experience in Drug safety/pharmacovigilance scientist role. Strong experience in case processing, aggregate safety analysis and writing periodic reports. Participate on risk management planning and safety review teams as needed. Manage and participate in the preparation, analysis and writing of ad-hoc and aggregate clinical safety, labeling support documents, and risk management documents. Coordinate and contribute to the strategy, design and implementation of processes to manage safety data for the Products. Liaise with internal departments, external business partners, safety physician. Prefer experience within pharmaceutical industry. *********************************************************** To apply for a position send your resume to [email protected] Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Lyophilization Scientist- 1 year Contract (San Francisco Bay Area) To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: The Process Development Scientist will be responsible for lyophilization process development of cell suspensions, including lyophilization equipment start-up, development of lyophilization cycles, and characterization of lyophilized materials. The position is project-based with a duration of 1 year. The primary project goal is to address the challenges of lyophilizing and rehydrating biologically active human progenitor cells, and demonstrating the feasibility of preparing this form of preserved cell suspension. This cutting-edge research in lyophilization science serves as a substantial opportunity to contribute to expanding the commercializability of cell therapies products. • Start-up and maintain lyophilization equipment; train and supervise use of equipment by junior staff. • Start-up and maintain analytical equipment for lyophilized material characterization; develop test methods. • Design, execute and interpret experiments to develop lyophilization cycles for cell suspensions. • Author reports; present results in cross-functional forums. EXPERIENCE AND QUALIFICATIONS: • PhD with 0-2 years experience or BS/MS with 2-10 years of previous experience. • Fundamental knowledge of lyophilization principles. • Experience developing lyophilization cycles for biologics. • Knowledge of analytical instrumentation/methods employed in lyophilized product characterization. • Demonstrated skills in designing, executing and interpreting experiments. • Desirable experience: o Design of Experiments and Statistical Modeling.

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o Cell culture and cell characterization. o Experience supervising junior staff. ********************************************************************** Recruiter Email : [email protected] Medical Device Business Development Representative Western US Location: West US Category : Business Development Location/City : US - Western US Id : 897 Job Type : Permanent Salary Range : 75000.00 - 90000.00 per year (USD Permanent) Business Development Account Executive - Surgery | Medical Device | Integrated Operating Room The Business Development Executive will provide leadership in the identification, prioritization, evaluation, negotiation and relationship management of complex, strategic relationships at the OEM level with large national medical imaging and surgical companies. Understanding and experience working with digital operating room environment is critical as is your knowledge of medical imaging software such as imaging visualization, image manipulation and storage, data transfer, imaging modalities and dynamic and complex relationships. Additional experience in a surgical sales or business development role is preferred. This position requires surgical experience and deep knowledge of how products are integrated into the digital operating room. JOB DESCRIPTION 1. Generate new business by scanning the global medical surgery marketplace and developing a solid strategy to attack new accounts, new markets, and to assist in the evolution of product development geared to the digital operating room. 2. Generating proposals, provide input on pricing, active lead generation and development, product promotion & introduction to the end-user, steer projects to the most appropriate channel, sales funnel tracking & management, close business and exceed quota, perform product demonstrations during onsite customer visits and provide accurate sales forecasting. 3. Extensive travel, up to 50%, nationally to new and existing accounts. Goal is to develop a deep understanding of their products and long-term business strategies, and to then sell the capabilities and values of our Client's company and associated technology. 4. Interface at the most senior levels at a customer site with the ability to win customers in a compressed buying cycle by negotiating and closing complex deals that benefit our Client including multi-year OEM and reseller agreements with major surgical and radiology Companies. 5. Developing end user sales opportunities, handle key account relationship management, develop partner relationships with sales channels, perform product demonstrations and foster collaborative relationships with luminary hospital sites. 6. Provides weekly activity/call reports, trip/travel reports, and weekly/monthly sales reports and forecasts/activity.

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7. Meet all sales and business development goals, including profitability as measured by gross margins. 8. Working with Finance, Customer Care, Operations, Product Engineering, Marketing, Sales and other internal departments to understand their strategic priorities and creatively identify partnership opportunities to support those priorities. 9. Establishing metrics to analyze and track performance of partner initiatives. PROFESSIONAL QUALIFICATIONS Understanding of the surgical environment and medical imaging protocols, visualization software, PACS, Dicom, image manipulation and storage, data transfer, imaging modalities and dynamic and complex relationships. Ability to work in a dynamic, entrepreneurial organization, in both a team and independent environment. Familiarity with the Imaging / Radiology / Radiologic Software technology marketplace is critical. Proven ability to negotiate and close complex technology deals in with a surgical or radiology focus. Experience with creating and leveraging new markets and new channels is a plus. Bachelor's degree in a marketing, engineering, business-related discipline with an MBA preferred or equivalent work experience. 5-10 years of strategic alliance or business development experience in the Surgery or Imaging Industry required with a strong preference for orthopedic surgery, neurosurgery, cardiovascular surgery, cath lab or cardiology, surgical robotics, or endoscopy. OUR CLIENT LOOKS FOR CANDIDATES WITH THESE (OR SIMILAR) COMPANIES IN THEIR BACKGROUND: Acuson, “AFP Imaging" Agfa Aesculap, Analogic, Apteryx, Accuray, Arthrex, “Banyon Medical" Canon, Cedara Cisco ContextVision “Del Medical" “Eastman Kodak" “Fischer Imaging" Fuji “Fujifilm Medical" GE “Given Imaging" , “Google Healthcare" Hitachi Hologic Intel “Imaging Dynamics" IDC, InfiMed “Instrumentarium Imaging" Kodak “Lantheus Medical Imaging" Lodox Maquet “Matrox Imaging" “Medicor Imaging" “Mercury Computer" Microsoft MinXray “Mirada Solutions" Nucletron, Optimus “Pegasus Imaging" Philips, Qualcomm, “Quantum Medical Imaging" Samsung, “Schick Technologies" Siemens Swissray Telerecon Toshiba TI UltraSPECT, “HAI Vision” “IP Video” “Varian Medical" “FLIR Systems" BrainLAB, GE Navigation, “Richard Wolf" Intuitive Surgical, “Olympus Medical" IMRIS, Invivo, Datascope, Stereotaxis, Medtronic, Stryker, Draeger, SkyTron, Olympus, “Applied FiberOptics" “Philips Healthcare" “Stryker Instruments" “Smith & Nephew" Conmed, “Trumpf Medical" Praxim, Corindus, SensAble

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Technologies, Titan Amadeus, Curexo, Procure, Tomtec, Stanford Robotics Lab, Cyberkinetics, GE, General Electric Philips, Phillips, Siemens, Toshiba, Hitachi, Abla-Tx, Ablation Frontiers, Aeris Therapeutics, Afx, BEI Medical, Rita Medical, Sanarus, Veran, Vivant Medical, “Medtronic Ablation Frontiers” Barrx, Cardima, Intuitive Surgical, Spectranetics, BSD Medical, Angiodynamics, Epicor, Novacept, MedicalCV, MAKO, “Biosense Webster” Spectranetics, Estech, ProRhythm, Abbott Medical Optics, AMO, “Abbott Vascular” IsoRay, Accuray “Karl Storz” “Advanced Cardiac Therapeutics” Lumenis, AngioDynamics, ArthroCare “Medtronic Ablation Frontiers” Medtronic , Barrx “Biosense Webster” Biotronik, “Boston Scientific “ BrainLAB , Olympus , OmniGuide, “C. R. Bard” Cardima, OptiMedica “Carl Zeiss” Meditec , “Catheter Robotics” ConMed , “Cooper Surgical” Covidien “Salient Surgical” Sanarus, Cutera, CryoCor, Cynosure, SenoRx, “Smith & Nephew Endoscopy” Dornier, “Solta Medical” Elekta, Spectrasonics, “St. Jude Medical” “Ellman International” “Starion Instruments” Stereotaxis, Endocare, HealthTronics, “Stryker Interventional Spine” Endosense, Syneron, Theragenics, TomoTherapy, Estech, “Ethicon Endo-Surgery, “Focus Surgery” Gynesonics, Urologix, “Gyrus, ACMI “US HIFU” “Halt Medical” Valleylab, Covidien, “Hansen Medical” “Varian Medical” HealthTronics , ViewRay, Visualase, Hologic, “VNUS Medical” Xoft, Insightec, “Zeltiq Aesthetics “ “Integra Life Sciences" "BSD Medical" ____________________________________________________________________ Director of Quality Assurance, Medical Device Location: CA Category : Quality Assurance Location/City : CA - San Diego Id : 904 Job Type : Permanent Salary Range : 120000.00 - 135000.00 per year; 35% target bonus Recruiter Email : [email protected] Director of Quality Assurance, Medical Device You will lead and manage a Quality Assurance team and manage quality systems, design controls, product performance testing and evaluation, and non-conformance systems in a Medical Device Company. You will be responsible for following FDA regulations and ensuring that processes and procedures meet requirements of ISO 13485, GMP, MDD, and CMDR and other regulatory requirements. Manages: 10+ Direct Reports Location: Southern California Qualifications

Minimum 10 years’ experience in Quality Assurance role in medical device BS degree in life sciences, engineering or a clinical discipline required; Masters degree

preferred. Experience with ISO 9001 required; prefer experience with ISO 13485 Lean/Six Sigma certification preferred Strong leadership skills in strategic planning and management of business objectives

working within a regulated environment. Technical competencies to assess, manage or provide guidance in the following areas:

Quality Planning Reliability and failure analysis and risk assessment / management Root cause analysis, problem solving, continuous improvement, CAPA Defining and Compliance with technical standards Position Summary:

Develop and direct annual goals and objectives for Quality Assurance group, ensuring they align with the company's quality and organizational goals and objectives

Ensure compliance with all relevant quality assurance requirements and guidelines.

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Develop standards, metrics, and reporting tools that enable monitoring of progress towards the attainment of quality objectives.

Provide direct supervision, coaching and mentoring to team. This includes the areas of priorities, work directions, objectives settings, developmental opportunities and performance management

Assist the Quality Systems group in implementing improvements to and compliance with the quality system.

Keywords for this position include: “Quality Engineer” “Director of Quality” “Director of Quality Assurance” “Director of QA” “Manager of Quality” “Manager of Quality Assurance” “Manager of QA” Quality, QE, "Quality Engineer" "Quality Assurance" Validation, FDA GR&R, QSR, CQE, IQ OQ PQ, DFMEA, CAPA, ISO, "Quality Systems" 13485, ASQ, CAD, Minitab, ANOVA, BSME, BSEE, BSBME, "Certified Quality Engineer" "Certified Quality Auditor" "distribution analysis", DOE, "significance test", "process capability", "sampling plans" regression, lean, ”Medical device” “White box testing” “Statistical technique” CAPA NCMR, “root cause” reliability “failure analysis” “post market surveillance” “acceptance criteria” validation verification, PDP “V&V” DFMEA, 13485 _____________________________________________________________ Recruiter Email : [email protected] _ Clinical Specialist - Spine - Southern CA Location: CA Category : Clinical Affairs Location/City : - Southern CA Id : 887 Job Type : Permanent Salary Range : 60000.00 - 75000.00 per year; $120,000 at plan Clinical Specialist – Spine | Spinal Deformity Clinical Applications |Clinical Product Specialist The Clinical Specialist will assist surgeon during complex adolescent or adult deformity cases. The ideal candidate will need to know the product and each of its components and indications in order to support the surgeon and staff before (planning) and during the cases. This position is within a Publicly Traded, well-funded, commercial mid-stage spine company. You will “take ownership” to insure the success of key sites and work in both business and clinical areas to insure success in the use of the product, and also be the technical expert on the spinal products and instruments in order to provide case coverage during any surgery. You will have the opportunity to learn and excel in the sale of complex spine devices and potentially move into a Regional Director role in a 2-3 year timeframe. If you aren’t interested in selling a “me too” product, but instead want to join a company focused on helping complex spine surgeons improve the outcome for the patient, this is the opportunity for you. Responsibilities

Educate/train physicians and hospital personnel, including OR staff Develop close relationships with the spine surgeon’s office & hospital surgery schedulers

and obtain 30-60 days surgery schedule to be accessible for case coverage; log schedule into SaleForce.com

Answer a wide range of questions concerning surgical applications, as well as clinical technique related to spinal implants.

Execute Clinical aspect of the Sales Cycle (including in-servicing, training, scheduling) including administration tasks such as obtaining prior permission to attend surgery, securing purchase order and other issues related to POs and invoice approvals in purchasing.

Perform troubleshooting procedures to identify and resolve problems quickly and with confidence.

Produce well-written post-training reports and to provide written product feedback

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Assist Regional Directors in setting up meetings with new target surgeons and providing clinical expertise when requested.

Be the clinical lead during surgery’s direct surgery; attending 100% of the case, securing everything prior to surgery and be on call for emergencies of any nature in the 48hrs before the case

Education/Experience: A true passion for complex spine surgeries BS BA, in Nursing, Biomedical Engineering or Associates or equivalent experience. Clinical experience; years of experience working in orthopedics (complex deformity

spine); Experience in MIS with emphasis in Orthopedic Surgery and applications Knowledge of surgical complications in spinal surgery Understanding of human anatomy & physiology and medical terminology Strong & positive relationships with orthopedic surgeons and/or surgery personal Ability to go into surgery room and support surgeon during long and complex surgeries

Keywords for this position: spine, neuro, orthopedic, cervical, lumbar, “pedicle screw” VBR, “vertebral body replacement”, thoracic, “spinal implant” “orthopedic implant” Spine, Spinal, Fusion, Implant, Bone, Lumbar, Decompression, Interbody, IBF, DDD, Disc, Vertebrae, Vertebra, Screws, Spondylolisthesis, Thoraco-lumbar, Lumbar, Endplate, Sacral, Impingement, Scoliosis, Deformity, ALIF, PLIF Prior experience from the following companies (or similar) is helpful: Allosource, Aesculap, Alphatec, Amedica, Anulex, Archus, Arthrocare, Atlas Spine, Avalign, Baxano, Benevenue, Biomet, Biomimedx, Centinel Spine, Choicespine, Codman, Depuy, Dfine, DiscMotion, DJO, Eminent Spine, Endius, Exactech, Flexuspine, Globus, Greatbatch, Integra LifeSciences, Integra Spine, Interventional Spine, Invuity, ISTO, Joimax, K2M, Kensey Nash, Kyphon, Lanx, LDR, Lifespine, Magellan Spine, Mako Surgical, Mazor Robotics, Medtronic Spinal, Medtronic Spine, Mekanika, Nexgen Spine, Nspine, Nuvasive, Orchid, Ortho Development, Orthofix, Orthovita, Osteomed, Osteotech, Pacific Spine, Paradigm Spine, Phygen Spine, Pioneer Surgical, Premia Spine, Raymedica, RTI Biologics, Seaspine, Simpirica, Simplicity Orthopedics, Sintea Biotech, Smith Nephew, Spartek Medical, Spinal Elements, Spinal Kinetics, SpinalMotion, Spine Align, Spine Smith, Spine Surgical, Spinecraft, SpineNet, Spineology, Spinesmith, Spinevision, Spinewave, Stryker, Stryker Spine, Surgical Orthomedics, Synthes Spine, Thekan Spine, Titan Spine, Trans1, Ulrich Medical, US Spine, Verticor, Vertiflex, Vertos Medical, Wenzel Spine, Wright Medical, X-Spine, Zimmer, Zyga Technology ___________________________________________________ Recruiter Email : [email protected] Hybrid Operating Room Pre-Sales Integration Engineer - CA Location: CA Category : Engineering / Product Dev Location/City : CA - San Francisco Id : 898 Job Type : Permanent Salary Range : 110000.00 - 125000.00 per year (USD Permanent) Systems Sales Engineer – Surgery | Medical Device | Integrated Operating Room As a Pre-Sales Engineer you will build & maintain influential relationships and provide product presentation, technical product support, sales opportunity identification, and technical design assistance. A medical device company is seeking a business-savvy and technically inclined Sales Engineer to cultivate relationships with current and potential hospital OEM clients. This individual will be the technology "expert" for the company's product which involves a complex technical solution for hybrid operating rooms and surgical medical devices used in orthopedics, cardiovascular surgery, neurosurgery and general sugery along with medical imaging

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technologies such as MRI and CT as well as Dicom compliant displays, PACS, video, fluoroscopy, endoscopy, and visualization products used in the operating room, cath lab and POC in hospitals. You will be supporting strategic relationships with new and existing medical device and medical imaging manufacturing companies and key end user accounts in a capacity that requires technical knowledge in order to interpret customer requirements and to determine how to build products that best meet those requirements. Primary Responsibilities:

Act as "expert" for company's product in covered region, including ability to clearly present technical information

Assist partners with the onsite and remote development of custom API applications Establish, build, and maintain relationships with current and potential clients and

contacts in relevant facilities; promote sale and use of company's product and technologies with current customers

Coordinate with sales team to assist in penetrating new accounts Work with clients to define projects from onset through refinement process Identify and assess new and competitive technologies and market requirements as they

relate to company's current product line Manage technical aspect of entire sales process through the closure of the sale

Qualifications:

Engineering background PLUS 5+ years of highly successful strategic sales / sales engineering experience in the medical device field.

Solid experience with API development for OEM applications Solid technical knowledge of the operating room, integrated surgical devices and/or

capital equipment and how they are used in the operating room environment. Common technology experience: REST, HTTP, JSON, OO Object-Oriented programming

with application-specific experience to include: web-focused development: HTML, Javascript, AJAX, Jquery, Prototype Application-focused development: C#, dotnet, Java or similar programming language Proven pre-sales experience in the medical device industry and the technical mindset

required for a highly technical sale in the healthcare environment. Understanding of computer networking, the digital operating room preferred Excellent written and verbal communication skills, particularly the ability to

communicate complex technical information clearly Ability to travel extensively (up to 75%) Extensive knowledge of the operating room, operating room workflow, video, imaging,

patient monitoring, or diagnostic systems Education: Engineering degree required; MBA preferred Keywords for this position include: "Sales Engineer" "systems engineer" “Sales Applications” BSEE, BSME, MBA, MIS, video, endoscopy, robotics, "surgical suite" "image guided surgery" imaging, optical, optics, cardiac, laparoscopy, wireless, embedded, sales, "Pre-Sales Engineer" "technical sales" “medical display” “Digital operating room”

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OUR CLIENT LOOKS FOR CANDIDATES WITH THESE TYPES OF COMPANIES IN THEIR BACKGROUND: Acuson, “AFP Imaging" Agfa “Almen Laboratories" Aesculap, Analogic, Apteryx, Apple Accuray, Arthrex, “Banyon Medical" Canon, Cedara Cisco ContextVision “Del Medical" “Eastman Kodak" “Fischer Imaging" Fuji “Fujifilm Medical" GE “Given Imaging" GSF “Google Healthcare" Hitachi Hologic Intel “Imaging Dynamics" IDC, InfiMed “Instrumentarium Imaging" Kodak “Lantheus Medical Imaging" Lodox Maquet “Matrox Imaging" “Medicor Imaging" “Mercury Computer" Microsoft MinXray “Mirada Solutions" Nucletron, Optimus “Pegasus Imaging" Philips, Qualcomm, “Quantum Medical Imaging" Samsung, “Schick Technologies" Siemens Swissray Telerecon Toshiba TI UltraSPECT “Varian Medical" “FLIR Systems" BrainLAB, GE Navigation, “Richard Wolf" Intuitive Surgical, “Olympus Medical" IMRIS, Invivo, Datascope, Stereotaxis, Medtronic, Stryker, Draeger, SkyTron, Olympus, “Applied FiberOptics" “Philips Healthcare" “Stryker Instruments" “Smith & Nephew" Conmed, “Trumpf Medical" Praxim, , SensAble Technologies, Titan Amadeus, Curexo, Procure, Tomtec, Stanford Robotics Lab, Cyberkinetics, GE, General Electric Philips, Phillips, Siemens, Toshiba, Hitachi ____________________________________________________ Director of Quality Assurance, Medical Device Location: CA Category : Quality Assurance Location/City : CA - San Diego Id : 904 Job Type : Permanent Salary Range : 120000.00 - 135000.00 per year; 35% target bonus Recruiter Email : [email protected] Director of Quality Assurance, Medical Device You will lead and manage a Quality Assurance team and manage quality systems, design controls, product performance testing and evaluation, and non-conformance systems in a Medical Device Company. You will be responsible for following FDA regulations and ensuring that processes and procedures meet requirements of ISO 13485, GMP, MDD, and CMDR and other regulatory requirements. Manages: 10+ Direct Reports Location: Southern California Qualifications

Minimum 10 years’ experience in Quality Assurance role in medical device BS degree in life sciences, engineering or a clinical discipline required; Masters degree

preferred. Experience with ISO 9001 required; prefer experience with ISO 13485 Lean/Six Sigma certification preferred Strong leadership skills in strategic planning and management of business objectives

working within a regulated environment. Technical competencies to assess, manage or provide guidance in the following areas:

Quality Planning Reliability and failure analysis and risk assessment / management Root cause analysis, problem solving, continuous improvement, CAPA Defining and Compliance with technical standards Position Summary:

Develop and direct annual goals and objectives for Quality Assurance group, ensuring they align with the company's quality and organizational goals and objectives

Ensure compliance with all relevant quality assurance requirements and guidelines. Develop standards, metrics, and reporting tools that enable monitoring of progress

towards the attainment of quality objectives.

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Provide direct supervision, coaching and mentoring to team. This includes the areas of priorities, work directions, objectives settings, developmental opportunities and performance management

Assist the Quality Systems group in implementing improvements to and compliance with the quality system.

Keywords for this position include: “Quality Engineer” “Director of Quality” “Director of Quality Assurance” “Director of QA” “Manager of Quality” “Manager of Quality Assurance” “Manager of QA” Quality, QE, "Quality Engineer" "Quality Assurance" Validation, FDA GR&R, QSR, CQE, IQ OQ PQ, DFMEA, CAPA, ISO, "Quality Systems" 13485, ASQ, CAD, Minitab, ANOVA, BSME, BSEE, BSBME, "Certified Quality Engineer" "Certified Quality Auditor" "distribution analysis", DOE, "significance test", "process capability", "sampling plans" regression, lean, ”Medical device” “White box testing” “Statistical technique” CAPA NCMR, “root cause” reliability “failure analysis” “post market surveillance” “acceptance criteria” validation verification, PDP “V&V” DFMEA, 13485 *********************************************************************** Statistical Programmer -- Pharma -- South SF Real Staffing Group - San Francisco Bay Area Real Staffing One Sansome Street, Suite 3630 San Francisco, 94104

Group: USA Contract Telephone: +1 415 796 8050 Contract Fax: +1 415 796 8099 Permanent Telephone: +1 415 796 8000 Permanent Fax: +1 415 796 8099 Permanent Email: [email protected] Job Description POSITION SUMMARY: To provide SAS programming support for the Clinical Research Programming Department. ESSENTIAL FUNCTIONS: 1. Develop and document programs to create analysis datasets summarizing key clinical trial data. 2. Develop and document programs and to produce tables, listings and other reports and analyses summarizing clinical trial results. 3. Perform and document quality control checks for programs. 4. Assist in testing and implementation of new and updated internally and externally developed software as well as new SAS releases. OTHER RESPONSIBILITIES / DETAILED DUTIES: 1. Participate in the development and review of study-specific procedures; participate in clinical project team meetings as required. 2. Assist with the development of case report forms. Education: Bachelor’s degree or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth). Related Experience: 1. Minimum of 5 years experience programming and analyzing scientific data in a pharmaceutical / clinical trial environment.

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2. Expertise in SAS programming language. 3. Experience working in a PC SAS environment . 4. Must have good organization and written and oral communication skills Additional Information Posted: July 3, 2012 Type: Full-time Experience: Mid-Senior level Functions: Analyst, Consulting, Information Technology Industries: Medical Devices, Biotechnology, Pharmaceuticals Compensation: Competitive Job ID: 3328080 *********************************************************************** Celgene jobs http://jobs.celgene.com/go/Oncology-Research-Jobs/305628/ Sr. Administrative Assistant Job W

TN

Senior Research Associate, DMPK Job SDC

Director, Biotherapeutics Drug Discovery & Technology Development Job SDC

Sr Principal Scientist Job SN

Principal Scientist, DMPK Job SN

Principal/Sr. Principal Scientist, Oncology Research Job SDC

Senior Scientist, Translational Development Job SFC

Associate Bioengineer II Job WTN

Senior Scientist, Molecular Therapeutics Job WTN

Associate Scientist / Analytical Chemist, Medicinal Chemistry Job SDC

Clinical Production Associate Job WTN

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Specialist I, Translational Development Operations Job SFC

Principal Scientist, Medicinal Chemistry Job SDC

Scientist II Job SN

Principal Investigator Job SN

Senior Scientist, Translational Medicine, CCT Job WTN

Associate Scientist, Translational Medicine, CCT Job WTN

__________________________________________________________________________________ See details for following pharmaceutical positions at http://jobs.celgene.com/go/Pharmaceutical-Research-Jobs/305653/

Senior Research Associate, DMPK Job

San Diego, CA, US Jul 2, 2012

Director, Biotherapeutics Drug Discovery & Technology Development Job

San Diego, CA, US Jun 29, 2012

Principal Scientist, DMPK Job Summit, NJ, US Jun 26, 2012

Senior Scientist, Molecular Therapeutics Job

Warren Township, NJ, US Jun 22, 2012

Specialist I, Translational Development Operations Job

San Francisco, CA, US Jun 20, 2012

Principal Scientist, Medicinal Chemistry Job

San Diego, CA, US Jun 15, 2012

Principal Investigator Job Summit, NJ, US Jun 9, 2012 Results 1 – 7 of 7

************************************************************************ Please send your CV to: [email protected] Urgent: Principal Scientist (San Francisco Bay Area) - fulltime permanent and preferably locals Desired Skills & Experience • Ph.D. degree in Formulation Science, Pharmaceutical Science, Polymer Science, Colloid and Surface Science, Organic Chemistry or related field with a minimum of 10 years of relevant

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industrial work experience, and a minimum 5 years of supervisory experience in industry. • Desirable experience in development of bench scale and manufacturing scale agricultural or pharmaceutical formulations. • High level expertise in aqueous solution chemistry with complete knowledge of pH, buffers, rheology, and phase transitions. • Desirable experience with colloids, surface science, microbial derived-products, plant-derived products, biopesticides and dehydration technologies. • Experience in carrying out of the following procedures is desirable: rheometry, particle size analysis, gravimetric analysis, microscopy, sieving, blending/mixing, wet/dry milling, coating, extrusion, lyophilization, spray drying and drum drying. • Understands performance and ingredient requirements of regulated agricultural and household use pesticide products in North America and the European Community. • Must have expertise in regulations concerning product ingredients including US EPA, FDA, and USDA. • Experience in technical transfer of formulation process to contract manufacturing facilities. ************************************************************************ For a complete listing of the most recent jobs at the CACO-PBS website: http://www.caco-ca.org/aspx/jobs.aspx To view details of a job on the following list: go to website and click on positions Employer / Position Hunter Labs : Clinical Laboratory Scientist NEW Genentech : Scientist/Senior Scientist- Small Molecule Analytical Chemistry Gilead Sciences : Manager QC- Stability Studies Req #9119 Judge Group : Sr Scientist Judge Group : Sr Scientist Judge Group : Sr Scientist ******************************************************************* To apply, please click the link below: careers.imshealth.com careers.imshealth.com

IMS Consulting Group is looking for Experienced Consultants/Project Leaders in Redwood City, CA and New York City! Now Hiring: Consultant/Project Leader in Redwood City, CA and New York City, NY IMS Consulting Group is the world’s leading, specialized advisor on critical business issues in the life sciences, and is the management consulting arm of IMS Health, a leading provider of information, services and technology for the healthcare industry in 100+ countries around the world. Our IMS Consulting Group teams offer end-to-end management consulting in key issues areas that include: business unit, therapy area and brand strategy, portfolio strategy, launch strategy, pricing & market access studies and commercial model design and optimization. Individuals joining us are assured of a rewarding career in life sciences consulting, replete with opportunities to address diverse and challenging client problems, travel on cross-geography projects, interact with senior client leaders and gain exposure to a truly multi-cultural, collegial and collaborative work environment. Responsibilities: Working closely with an Senior Leaders and Principals, you willl be responsible for managing consulting teams in the design, development and delivery of medium size consulting projects or components of larger, complex projects by: •Planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives •Performing quantitative or qualitative analysis to assist in the identification of client issues and the development of client deliverables

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•Designing, structuring and delivering client reports and presentations •Developing client relationships •Supporting the development of intellectual property for use on future engagements •Developing broader and deeper knowledge of consulting methodologies and pharmaceutical market through on the job experience and training •Coaching project team members and supporting them to fulfill their personal objectives •Mentoring analysts and consultants Skills and Experience: •Strong capability in managing projects and juggling priorities so that deadlines are met while retaining consistently high quality outcomes •Experience of working in sizable/multi-disciplined teams and supervising staff •Willingness and ability to work effectively with others in and across the organization to accomplish team goals •Knowledge of key issues and current developments in the pharmaceutical and healthcare industries •Demonstrable analytical, interpretative and problem-solving skills •Excellent presentation, communication and client influencing skills •Understanding of consulting methodologies, tools and techniques Qualifications: •Experience in consulting, pharmaceutical and/or healthcare industry with evidence of career progression •A track record in team work and in developing and leading people •An MBA or relevant graduate degree and 6 or more years of experience •A willingness or ability to travel *********************************************************************** To apply for a position send your resume to [email protected] Program Manager-Molecular Diagnostics (MDx) - Full Time or Contract Position (San Francisco Bay Area) To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. No Work Visa sponsorship is available for this job. DESCRIPTION: The Program Manager for the Molecular Diagnostics (MDx) Business Unit manages the development of internally developed diagnostics products or companion diagnostics products co-developed with external partners. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and may monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required. Essential Functions: • Leads cross functional core team through product launch • Develops project plan and timeline • Coordinates with external Assay Partner teams to achieve project / product deliverables • Be the internal expert in PCP process and IVD project management.

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• Act as “mini GM” as leader of cross functional core team. • Act as communication liaison with Business Unit Management to assure deliverables are met, appropriate resources are applied and team(s) remains focused and engaged Competencies: • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. Must be a highly-motivated driver able to complete tasks by leveraging relationships and established goals. • Has analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations. • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints • Discusses and presents factual information to other members of the team. Ability to convey very complex information in both written and oral form. Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to MDx management. Able to influence others and gain acceptance and build consensus. • Ability to manage moderately complex projects and initiatives. • Acts as a mentor/role model for team members. • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services. • Makes decisions that involve the consideration of complex issues. • Works autonomously and checks-in as decisions are made. EXPERIENCE AND QUALIFICATIONS: • The candidate will have 3-5 years of project management experience in IVD product development **** Experience with Device Design Control and biological/PCR based diagnostics is strongly desired • Working knowledge of design control and FDA QSR requirements • Microsoft Project Management skills • The candidate will have proven ability to execute through influence within a matrixed organization • The candidate will have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required • In their repertoire, the candidate will be self-motivated & a driving force of execution in their current or past organizations • Experience working with external collaborators; Negotiations skills; Leading through influence • Strong written and verbal communication skills • Strong presentation skills • PMP certification is preferred ********************************************************************************

Jobs That Crossed My Desk Through June 26, 2012 ********************************************************************* To apply for a position send your resume to [email protected] Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Manager, Sr. Manager, Regulatory Affairs CMC - Contract or Full Time Position (San Francisco Bay Area) To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. *Current U.S. work permit

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status required. No VISA sponsorship provided* DESCRIPTION: Expertise with biologics and/or small molecule experience is essential. Manage CMC aspects of domestic and international regulatory affairs for multiple commercial and clinical projects. Responsible for obtaining and interpreting global CMC regulations and guidance and providing regulatory advice to Quality and Manufacturing team members. Work closely with CMC teams, corporate partners, and contract manufacturing organizations to prepare complete and accurate CMC submissions and meet established timelines. Responsible for interaction with global Regulatory authorities to ensure acceptance, rapid review, and approval of marketing applications, supplements, Variations, clinical trial applications, and other filings which present CMC information. Demonstrated strong communication and submission/ personnel management skills are required. • Plan, manage, and oversee preparation, and submission of global CMC submissions, including marketing and clinical trial applications. • Ensure that CMC content is complete, well-written, and meets all relevant requirements. Assess proposed manufacturing changes for global impact, and provide strategic regulatory guidance for optimal implementation of changes. • Provide regulatory advice to technical operations departments based on knowledge of current requirements. • Manage interactions with FDA or other regulatory authorities for assigned projects. • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners. • May supervise one or more Associates. EXPERIENCE AND QUALIFICATIONS: • BA/BS degree in life sciences is required; advanced degree is a plus. • Required: o At least 5 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to both development and commercial phases of product lifecycle). o Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S. and/or Europe. o Experience in assessing post-marketing changes is critical. o Proven ability to lead cross functional CMC teams on projects and sub-teams. o Thorough understanding of relevant CMC drug development regulations and guidelines. o Outstanding interpersonal and communication (written and verbal) skills. o Proficiency with standard software programs (e.g., Word). • Preferred: o Proven ability to successfully interact with Regulatory Authorities. o eCTD experience is desirable. o Demonstration of effective skills in managing regulatory professionals. o Strong background in chemistry, molecular biology, or similar is desirable. _______________________________________________________________ r Manager to Director Clinical Supply Chain - Contract or Full time position (San Francisco Bay Area) To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. *Current U.S. work permit status required. No VISA sponsorship provided*

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SUMMARY: Ensures uninterrupted drug product supply to all clinical study patients. The scope of responsibility includes leading the creation, management, and communication of supply, demand and operational plans from drug substance production through study close out activities. Success in this role requires working effectively with leaders in Program Management, Clinical Operations, Regulatory, and Technical Operations, including Clinical Manufacturing, Packaging/Labeling, Logistics, and Procurement. Additionally, this role must integrate external business partners into the overall Clinical Supply Chain team and build an integrated, high performance operation to manage ’s expanding development portfolio. DESCRIPTION: • Continue development of the Clinical Supply Chain team through effective leadership and mentoring to become a global, high performing organization, including: o Strong understanding of clinical study design, execution, and impact of drug product supply. o Strong understanding and effective use of advanced supply chain management techniques and tools. o Understanding of international logistics. o Strong and proactive use of problem solving, communication, and leadership skills. o Collaboration and teamwork. • Build processes and relationships with Clinical Operations, contracted clinical research organizations (CRO’s), Study Site teams, and other external parties to create an integrated end to end clinical supply chain that is effective and adaptive to new challenges. • Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, patient weight as appropriate, etc. • Collaborate with appropriate groups and project teams to design supply strategies that successfully achieve corporate goals. • Collaborate with multiple functions to recommend a clinical product configuration that supports trial design and encourages subject compliance. • Proper execution of this role is essential for successful studies as it both defines clinical supply needs and delivers on those needs. • Multilevel inventory management is critical to ensure adequate supply is available for continuous treatment of the subject. • Production planning in this role governs the use of the Clinical Manufacturing facility and planned work at contract manufacturers. • Capacity planning in this role provides guidance for future investment needs. EXPERIENCE AND QUALIFICATIONS: • Bachelors in science, engineering or supply chain related major required, Masters preferred. • Required: o Clinical supplies or Clinical Research training. o Proficient knowledge of Microsoft Excel, PowerPoint and Project software. o Minimum 8 - 10 years experience in the clinical supply chain field. o Working knowledge of current GMP/GCP regulations. o Clinical supplies or clinical research experience. o Inventory management experience required, 2 years minimum. • Preferred: o Proficient in Operational Excellence, Lean Process development, Six Sigma tools and techniques is highly desirable. o Formal forecasting or statistics training.

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o APICS certification (CPIM, CRIM, CSCP). o IXRS experience. o Distribution experience, including Cold Chain. o Experience in Oracle. To apply for a position send your resume to [email protected] Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com **************************************************************************** Apply Here - http://jobvite.com/m?3Bgvnfwt Apply Here hire.jobvite.com Scientist/Sr. Scientist, Bioinformatics | South San Francisco, California Summary: As part of our commitment to bring effective therapies to patients with cancer, we are seeking a motivated computational biologist to join a new team focused on the development of personalized medicine for patients with malignant disease. Employing data from state-of-the-art genomic analyses, the bioinformatics scientist will discover molecular signatures (e.g., combinations of somatic mutations and gene expression patterns) that predict clinical response to Onyx compounds, including carfilizomib and oprozomib, in patients with multiple myeloma and solid tumors. Signatures will be derived from the genomes and transcriptomes of tumors biopsied from patients on Onyx clinical trials and of cancer cell lines exposed to Onyx drugs; publicly and commercially available genomic databases (e.g., GEO, dbGaP and NextBio) will also be employed. A second goal will be to identify novel therapeutic targets, especially for non-responsive patients. The new hire will collaborate internally with both preclinical research and clinical science in order to validate pathways associated with drug response and translate findings into clinical practice, thereby gaining rare exposure to the entire drug development process. The scientist will also collaborate externally with international academic institutions, research consortiums and CROs. Summary: As part of our commitment to bring effective therapies to patients with cancer, we are seeking a motivated computational biologist to join a new team focused on the development of personalized medicine for patients with malignant disease. Employing data from state-of-the-art genomic analyses, the bioinformatics scientist will discover molecular signatures (e.g., combinations of somatic mu Expiring in 12 days ******************************************************************* Apply on company website Director – Commercial Planning & Operations (Strategic Forecasting) Gilead Sciences - Foster City, Ca, SF Bay Area (San Francisco Bay Area) Job Description The high-performing candidate will leverage a broad skillset (functional expertise, therapeutic knowledge, communication skills, etc.)to help drive the success of Commercial Planning & Operations department’swork with a variety of key internal customers – including R&D andCommercial Project Teams, functional Commercial Operations leadership, Project& Portfolio Management, Finance, Corporate Development, and globalCommercial leadership including the

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EVP Commercial Operations. This role willhave responsibility for leading long-term analytics/forecasting that is usedfor a variety of key Gilead business decisions(internal pipeline, M&A, etc.). The role will also include select areas ofdirect responsibility for market/revenue forecasts (e.g., respiratory assets,M&A assessments). The role will report to the Senior Director, Commercial Planning& Operations, will oversee 5 other professionals for the purposes offorecasting management, and will directly manage 2 professionals. Specific responsibilities include but will not be limited toexecution (or managing the execution) of the following: Analytics

Developand maintain long-term forecast models for marketed and pipeline products,including forecasts of epidemiological, competitive market, price, revenue, andcommercial expense data

Collaboratewith internal Market Research, Literature Resources,Competitive Intelligence, R&D, and Marketing/Sales leads to identify andinclude quality data assumptions into forecasting models

Carryout base-case and scenario modeling using long-term models to supportdecision-making by Commercial, R&D, Corporate Development, Finance, andCorporate executive leadership

Conductcomplex analytics (e.g., analytical patient segmentation analyses based onchart audits) derive key insights for use in marketing strategies

Workwith Market Research group to scope, design, and manage the execution ofquantitative market research (e.g., discrete-choice conjoint) to inform revenueforecasting via predictive patient share modeling

Examplesof decisions that may be informed by analytics include progression of internalassets through the R&D pipeline, partnerships or acquisitions of specificassets or whole companies, strategic portfolio mix, product pricing at launchand at the time of generic competition, etc.

Planning Workwith Gilead Finance and R&D by creating 10-year revenue and commercialexpense

forecasts across all Gilead productsfor use in internal financial reporting as well as portfolio-level R&D andM&A decision-making

Identifyand work cross-functionally to implement enhancements in Gilead’sfinancial planning processes

Other Leadad hoc strategy projects and initiatives (e.g. evaluating new markets)

forcommercialized, pipeline products and external opportunities Workingwith other members of product/franchise Commercial Planning & Operations

teamsto help shape Gilead’s approach to one or moretherapeutic areas Workwith group leadership to improve the efficiency, consistency, rigor, andcredibility

of operations in analytics, in collaboration with key globalpartners (US, Europe) Desired Skills & Experience Desired knowledge & skills:

Must be a proven strategic thinker with ability to formulate and develop commercial strategy

Must possess well-developed analytical skills, including market and financial modeling Prior experience conducting or analyzing quantitative market research (e.g., discrete

choice conjoints) data is high desirable Prior experience developing, implementing, and training others to use strategic

analytical and planning frameworks is required Evidence of group and/or project leadership (history of interaction with cross-functional

partners, conflict resolution, and consensus-driving) is required Must possess good task management skills-- planning, prioritization, objective setting,

and meeting management and plan execution

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Proven history of working and delivering on multiple projects simultaneously, with tight deadlines and changing priorities is required

Strong ability to use Microsoft Office (specifically PowerPoint and Excel) to present quantitative data in graphical form is required

. Specific Education and Experience:

A BS degree (or higher) in life sciences or medicine (or equivalent) is required, and an MBA is highly desirable

A minimum of 8+ years relevant experience in biotechnology or pharmaceuticals, including both deep analytics and some strategic planning experience is required

Experience in biopharmaceutical-focused investing and/or management consulting is desirable

Experience in one or more of Gilead’s areas of focus (HIV/AIDS, hepatic diseases, cardiovascular, respiratory) is desirable

Company Description Gilead was founded in 1987 in Foster City, California. In just over 20 years, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, growing pipeline of investigational drugs and approximately 4,500 employees in offices across four continents. In 2010, Gilead’s annual revenues reached nearly $8 billion, and in 2009, BusinessWeek ranked Gilead #1 in its annual listing of the 50 Best-Performing Companies. Additional Information Posted: june 13, 2012 Type: Full-time Experience: Director Functions: Analyst, Strategy/Planning Industries: Biotechnology, Pharmaceuticals Compensation: Base, Bonus, RSU's, 401K, Referral Bonus: Job ID: 3197535 ***************************************************************************** Apply on company website Sr Dir, Science Affymetrix, Inc. - Santa Clara, California (San Francisco Bay Area) Job Description Affy has a culture of continual innovation. It wants "raving fans" not just satisfied customers. The successful individual will embrace the company's culture and assist in its maturation. To be successful, the Senior Director of Applications Development must be flexible, transparent, an excellent communicator, collaborative, and deadline/results driven. He/She will have demonstrated leadership within a fast moving commercial operation. The Senior Director of Clinical Applications Development is a team player with strong leadership and motivational skills. This person must be a business leader as well as technically competent. This person uses imagination and creativity to develop and assist commercialization of innovative products for the validation and diagnostic marketplace. He/She will have high integrity with a strong bias toward action and a personal commitment to delivering quality products that meet regulatory and market requirements on time and within budget. This individual is a self starter who will possess excellent organizational, decision-making, process, human relations, and communication skills. His/Her management style will be one of team builder and collaborator.

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The Senior Director of Clinical Applications Development will be a business leader who collaborates with the leadership team to develop a vision for delivering innovative diagnostic products to market. This person will have the fortitude to take and defend a strong position with logic, be committed to results when decisions are made and fit into a dynamic high powered management team. This is the type of individual who has great desire and commitment to achieving results and is excited and even challenged by "mission impossible". His/her mission, purpose, and focus will be to lead clinical product development, for products that improve human life. RESPONSIBILITIES: The Senior Director of Clinical Applications Development plays a critical role in the delivery of robust, market driven applications advancing Affy's growth in downstream validation and clinical markets. He/She will integrate product development activities and multiple scientific teams in Wet Chemistry. By leveraging the talents of their group, he/she will raise the bar and develop their employees as individual leaders and as a cohesive team. With a focused commitment to Affy's mission to revolutionize how the world benefits from genetic information, this person will contribute to the company's leadership and product strategy, and execute development plans in a high-quality and timely fashion. Primary responsibilities will include: 1. Lead product innovation, execution and commercialization through active partnering with the commercial, Medical Affairs and product development organizations to provide robust and high quality clinical products. 2. Build on existing competencies for development of products and infrastructure under design control. 3. Lead, mentor and manage development personnel and resources. 4. Integrate multiple product development disciplines for assay development, advanced genetics, and wet chemistry. 5. Participate in generating, evaluating and modifying 3 year product roadmap for Product Development by engaging internal marketing teams and key thought leaders in the industry in the areas of market direction, product strategy, and collaborations in product development. 6. Embrace and execute on Company's Values and Behaviors Position Requirements: The Senior Director of Clinical Applications Development must possess the ability and desire to lead highly competent scientific and development teams. The successful candidate will assist in fostering innovation for the future and grow with the integration of new products through both acquisition and organic development. The Senior Director of Clinical Applications Development will: Have a minimum of ten years successful experience in the development of diagnostic and scientific products in a market driven company and a track record developing products against defined product requirements and deadlines. Have managed large technical programs and first-hand experience developing products under design control for regulated markets. Be adept at interacting with research focused organizations and colleagues.

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Have a track record in leading, mentoring and developing technical teams that deliver high quality products on schedule. Preferably have experience in clinical applications for microarrays ABOUT AFFYMETRIX Affymetrix (AFFX) is a pioneer in creating breakthrough tools that are driving the genomic revolution. The vision, innovation, and devotion of Affymetrix employees help us empower scientists around the world to alleviate human suffering. It is not just the sheer power of GeneChip® technology that inspires us; it is the potential for it to help people. The culture at Affymetrix is based on core values of daring, passionate and platinum. Our employees create a highly energized, team-oriented work environment. We are an employer committed to supporting the aspirations and achievements of our employees and offer our employees a comprehensive, competitive program of benefits and a corporate culture based on core values of daring, passionate and platinum. ••Affymetrix is an Equal Opportunity Employer. Our commitment to a diverse workforce is demonstrated through all aspects of our hiring and employment practices.•• Additional Information Posted: June 25, 2012 Type: Full-time Experience: Director Functions: Science Industries: Biotechnology Employer Job ID: 9400 Job ID: 3271717 ************************************************************* Apply on company website Product Manager / Senior Product Manager CardioDx - Palo Alto (San Francisco Bay Area) Job Description The role of the Product Manager/Senior Product Manager will be to lead projects related to marketing and driving increased adoption of CardioDx’s flagship product (Corus CAD gene expression test), assessing customer needs and defining the market opportunity for the next product launch in the cardiovascular space, monitoring the competitive landscape for both direct and indirect competitors, and supporting the company’s sales force needs. This role will require strong market research, analytical, and project management skills. Job Responsibilities

Lead and conduct market research in identifying new product opportunities, in evaluating the effectiveness of product messages with customers, and in understanding the clinical utility of Corus CAD in real-world clinical practice

Become the subject-matter expert and repository of information for all market research conducted, industry reports and market data

Benchmark the competition and stay on top of key technology developments and published clinical data in the noninvasive diagnostic market for coronary artery disease

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Provide expertise in the noninvasive diagnostic market for coronary artery disease and suggest strategies to support the positioning and marketing of Corus CAD

Interpret and translate scientific and clinical data for commercial utilization and product promotion

Create marketing materials (clinician and patient collateral) and sales tools to drive further adoption of Corus CAD

Develop and execute tactics to promote product through medical conferences, e-marketing, and speaker programs

Lead the definition of new products and upgrades to existing products by developing the customer requirements documents that is based on voice-of-customer and market research findings

Provide ongoing support to the sales team and customers as the product and clinical data expert

Support conferences, meetings, exhibits, and customer visits Manage resources and budget to execute all assigned programs

Desired Skills & Experience Previous experience in the cardiovascular disease market strongly preferred Strong interest in genomic testing and/or molecular diagnostics Strong analytical skills with ability to synthesize complex or diverse information, collect

and research data Passion for and aptitude in assessing products, customers, market dynamics and

competitive environment High degree of professionalism at work combined with strong ownership and

accountability of projects, deliverables, and due dates Self-motivated, resourceful, self-directed and can work independently on projects using

good judgment with minimal direction Ability to work as a team member and is respectful of other’s opinions that may be

different from one’s own Enjoys challenging projects that are not always clearly defined or structured, and can

self-direct and define what the project should look, ensuring alignment to the business objectives and the market and customer needs

Must be able to multi-task and adapt to a work environment that can be dynamic and changing

Outstanding written and oral communication skills Company Description CardioDx is a cardiovascular genomic diagnostics company located in Palo Alto, CA. CardioDx develops clinically validated genomic tests to aid in assessing and tailoring care of individuals with cardiovascular disease, including coronary artery disease (CAD), cardiac arrhythmias, and heart failure. Additional Information Posted: June 14, 2012 Type: Full-time Experience: Mid-Senior level Functions:Marketing Industries: Biotechnology Job ID: 3206952 **************************************************************** Apply on Depomed website Senior Director, Marketing (Women’s’ Health) Depomed, Inc. - San Francisco Bay Area

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Job Description Senior Director, Marketing This position reports to the Vice President of Marketing and is accountable for product strategy development and tactical execution across professional and consumer marketing efforts for Depomed’s growing Women’s’ Health franchise. Additionally, this person will lead and/or participate in the development of product life-cycle management plans, as well as high-level facilitation and communication with Sales Management to ensure field goals are supported with brand strategy and tactics. Requirements: · Lead the strategic development behind the professional & consumer marketing plans for Serada and other Women’s Health products Depomed may be selling · Responsible for leading and directing cross-functional team members (i.e.Medical, Regulatory, Promotion, Advertising Agency, Sales Operations, etc.) in the development of strategic and operational plans · Utilize strong communication skills to effectively communicate the marketing plan to the entire commercial organization · Develop and manage forecasts and budgets · Participate in the development and management of key customer and thought leader relationships · Compliance with Depomed internal processes regarding legal, regulatory and financial policies and procedures · Assess and develop marketing talent while coaching to achieve targeted results · Maintain a comprehensive and current understanding of relevant therapeutic markets, · Engage with internal customers on a consistent basis to bring an additional layer of strategic thinking and research expertise · Lead andsupport initiatives to improve the Teams processes and tools · Develop, manage, and track the Serada Marketing budget. Desired Skills & Experience Core Competencies: Team Management / Leadership skills:Articulates a clear direction and demonstrates the ability to motivate and positively influence others. Effectively manages people, projects, and budgets. Clearly defines performance standards for employees and gives recognition when appropriate. Ensures employees have clear measurable goals aligned with organization’s priorities and holds people accountable for results. Addresses performance and behavior issues in a timely manner. Inspires people to excel by modeling excellence and enthusiasm. Empowers teams to solve problems and initiate improvements. Identifies organizational needs and attracts, selects and retains talent. Decisions and Judgment: Gathers relevant information systematically and considers a broad range of issues or factors when making decisions; grasps complexities and sees the relationship among problems or issues. Uses a mixture of analysis, experience and judgment to make timely and effective decisions; evaluates results in order to improve future performance. Willing to make difficult business and personnel decisions and accept responsibility; decisions are timely, fact-based and well-reasoned. Teamwork/Collaboration:Establishes and maintains cooperative and productive working relationships with coworkers. Proactively and constructively resolves disagreements. Demonstrates support of team and companygoals. Provides unsolicited assistanceto others. Shares recognition and credit with others. Acts with integrity and earns the trust of others by dealing with them respectfully and honestly. Shows awareness and considers the opinions of others. Required Education, Experience, & Competencies:

Bachelor’s Degree Required; preferably in Life Sciences or Business, with an advanced degree in Business or Science strongly preferred.

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Demonstrated experience and success in the area of direct to consumer (DTC) and direct to patient (DTP) marketing.

Minimum of 12 years of applicable pharmaceutical marketing experience with a minimum of 5 years of management experience.

Demonstrated leadership skills and ability to manage complex processes and initiatives. Experience and the desire to work within a fast-paced department is required. Action-oriented with strong sense of urgency; responsive to others; meets service

expectations of others. Results driven; highly organized with strong ability to follow through, prioritize and

execute agreed upon plans without supervision. Leads by example; does what it takes to get a job done; enthusiastic and positive. Effective communicator – both oral and written; is clear, complete and consistent. Listens effectively; customer focused; establishes effective relationships to gain trust

and respect. Innovative; offers suggestions on ways to improve processes. Strong knowledge of Microsoft Word, Excel, and PowerPoint. Excellent organizational and time management skills.

Company Description At Depomed our employees are passionate about creating great. Since our founding in 1995 we've worked hard to create a great specialty pharmaceutical company with great products. Our expertise and hard work has led to FDA approval and commercialization of our two marketed products, Gralise and Glumetza, a pipeline with late-stage product opportunities, and the development of our Acuform™ delivery technology, a unique, patented, polymer-based technology designed to optimize drug delivery. We are currently seeking a Senior Director, Marketing to join our great team in Menlo Park. *Note- Some relocation assistance will be offered to the right candidate. Depomed is an Equal Opportunity/Affirmative Action Employer. Thisis a direct full time hire- No agencies please. Additional Information Posted: June 25, 2012 Type: Full-time Experience: Not Applicable Functions: Marketing Industries: Pharmaceuticals Job ID: 3269242 ********************************************************************** To Apply For Position Please Go To Company Website Www.Vivus.Com No Phone Calls Please Product Manager/ Senior Product Manager Healthcare Marketing Vivus Inc - Mountain View, CA (San Francisco Bay Area) Job Description

Develop, refine and execute product-level tactics that maximize Qnexa performance with healthcare professional audiences.

Translate the business strategy into prioritized tactics for key audiences (MDs, nurses, educators).

Be part of a team of marketing professionals to deliver compelling semester meeting resources that align with brand and senior sales leadership objectives. Ensure that marketing mix across portfolio and personal/non-personal promotions are optimized to meet revenue goals in the obesity market.

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Collaborate effectively with sales training to execute workshop objectives for semester. With team, manage advertising agency, including determination of services, required to

successfully launch lead brand. Develop deep insights into customer behaviors that allow Vivus to tailor programs and

messages to meet the unique needs of the institution. Collaborate in the development of physician or other HCP advisory boards. Collaborate in the development and execution of peer-to-peer programming and tactics Collaborate with Health Systems Marketing team to deliver pharmacy tactics. Collaborate with sales leadership to develop and execute key opinion leader focused

initiatives. Measure impact of programs, including promotional initiatives and REMs.

Desired Skills & Experience Bachelor’s degree, MBA preferred, in economics, business or life sciences. 5+ years of pharmaceutical or device industry experience with focus on marketing

including developing market strategies and executing tactics at the brand or segment level. Product launch experience desired.

Minimum of 2 years of experience in sales, sales operations, or sales training preferred. Requires a thorough understanding of the legal and regulatory environment in

pharmaceutical marketing. Previous responsibility for product demand generation. Demonstrated experience delivering high-impact resources for healthcare professionals.

Extensive understanding of healthcare delivery systems including retail pharmacy environment.

Experience in marketing on a prescription weight loss product or a product treating a related co-morbid condition is preferred.

Demonstrated track record of team leadership Strong marketing skills in planning, execution, leadership and communication (within

and outside of team). Inspire others by fostering a climate of energy, excitement and personal accountability

around their work. Ability to analyze data, gain insights and share information with others so innovative

solutions can be formed and executed. Ability to collaborate with internal and external groups and gain customer and patient

insights. Company Description VIVUS VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes, obstructive sleep apnea and sexual health. The company’s lead product in clinical development, Qnexa® is a proprietary once-a-day oral controlled release formulation of low dose phentermine and topiramate. Qnexa has completed phase 3 clinical trials for the treatment of obesity, including more than 4,500 patients. Posted: June 10, 2012 Type: Full-time Experience: Mid-Senior level Functions: Marketing Industries: Biotechnology Job ID: 3176179 **********************************************************************

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Connie Milburn <[email protected] Subject: Process Engineer I'm looking for a strong process/manufacturing engineer. Please let me know if you are aware of any who are currently looking. ********************************************************* Apply online at company website http://www.santeninc.com/ Director, Medical Affairs Santen - Emeryville, CA (San Francisco Bay Area) Job Description DEPARTMENT DESCRIPTION: Global Clinical Development and Medical Affairs consists of four (4) primary areas: Clinical Operations, Medical Affairs, Drug Safety and Biometrics. Global Medical Affairs is charged with the generation, maintenance, and communication of scientific data related to the safe and effective usage of Santen products. Global Clinical Development is responsible for the design, execution and analysis of clinical trials sponsored by Santen U.S. in support of domestic and global registration of drugs. PRIMARY PURPOSE OF POSITION: The Director, Medical Affairs leads the Medical Affairs function within Global Clinical Development & Medical Affairs provides fair balanced, objective, scientific information and education about Santen product(s) as well as gathers medical intelligence through peer-to-peer interactions with thought leaders, investigators and other healthcare providers to better patient outcomes. The Director demonstrates expertise and knowledge of products, patient treatment trends, clinical trials, and scientific activities within the disease area. He/She will also provide management of other MSLs and support the Head of Medical Affairs. MAJOR DUTIES OF POSITION: The Director serves as a source of advice for management and colleagues in Development, Research and Marketing organizations, by virtue of his/her extensive drug development experience and product knowledge. He/She must be able to provide fair balanced, objective, scientific information and education about Santen product(s) as well as gather medical intelligence through peer-to-peer interactions with thought leaders, investigators and other healthcare providers to better patient outcomes. The Director must demonstrate expertise and knowledge of products, patient treatment trends, clinical trials and scientific activities within the disease area. This person will support the Head of Medical Affairs and will work closely with Research & Development, and also Global Marketing. (50% effort). The position will assist with the following:

Publications planning Medical communication Medical Science Liaison management Medical content development and promotional review – Compliance Regulatory, and safe harbor guidelines Sales Force Training Medical education Investigator Initiated Clinical Trials / related clinical development Phase IV Trials Drug Registries Formulary Support Reimbursement and Pharmacoeconomic support Continuing Medical Education (CME)

Other areas of responsibility include: Proposes new directions for Clinical Research / Development (e.g., new product claims). Evaluates new business development opportunities as needed. Identifies and manages appropriate consultant staff as needed.

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Manages and cultivates key opinion leaders in the USA, and in the near future, globally. Ensures appropriate dissemination of clinical information, knowledge and services in a

timely, ethical and customer-focused manner. Keeps abreast of the current literature, therapeutic issues and competitive landscape

related to the relevant disease areas of focus. Contributes, as appropriate, to the ongoing medical/scientific, disease area and

product-specific training of internal Santen customers. Establishes status as a knowledgeable and trustworthy medical and scientific resource

for Health Care Providers (HCPs) with expertise and knowledge of supported product(s), treatment trends, clinical trials and scientific research.

Communicates current and emerging clinical research data to HCPs in response to unsolicited inquiries.

Identifies medical experts to provide services as speakers, consultants, and investigators.

Delivers scientifically focused, balanced, and objective educational presentations to groups of strategic importance such as hospital and payer P&T committees.

Trains speakers for promotional programs on product knowledge, clinical/scientific data and information consistent with established company policies and compliance guidelines.

Provides constructive feedback to speakers regarding accuracy and delivery of scientific data and adherence to compliance policies.

Participates and interacts with HCPs, including preparing moderators at national, regional and local conferences, advisory boards and other approved gatherings.

Gathers scientific and competitive intelligence as well as customer insight during interactions with thought leaders or attendance of congresses and communicate to relevant Medical Affairs and Clinical Development personal.

Contributes to the development of the Global Medical Plan by communicating insight and knowledge derived from HCPs and/or scientific publications. Keeps abreast of the current literature, therapeutic issues and competitive landscape related to the relevant disease areas of focus.

Desired Skills & Experience Ability to work from Emeryville, CA Familiarity with the ophthalmic community desired Previous experience as part of a medical affairs team Advanced degree MD or PhD Creativity and innovativeness are clearly expected. Should have supervised a number of

clinical studies (or fewer if some are large multicenter studies), which have yielded clear-cut results and demonstrated the ability to establish satisfactory interpersonal relationships with others in the working environment, and to manage other physicians.

Proven track record of success, especially in the area of thought leader engagement and experience working with academic centers of excellence Exemplary interpersonal communication skills, both oral and written, and strong presentation skills.

Demonstrated ability to comprehend complex scientific data and concepts and communicate effectively to a variety of audiences

Authored papers in leading journals or evidence of having supported such publications. Presented scientific data in conferences and supported the preparation of such

presentations by KOLs. Awareness and understanding of regulatory guidelines (FDA, PDMA, PhRMA, etc.). Outstanding leadership characteristics exemplified through clarity of goal setting,

theability to inspire others, to set a positive example by providing assistance, recognition and encouragement.

Strong analytical, conceptual, administrative, and computer skills. Ability to approach work with a strong domestic and global perspective.

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PHYSICAL DEMANDS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. The individual must be able to travel 25-50%, domestically and globally. EMPLOYEES SUPERVISED: none currently Company Description Santen specializes in original ophthalmic and anti-rheumatic pharmaceuticals as it works to create superior pharmaceuticals for all types of ophthalmic disorders and offer information that meets clinical needs. With marketing and development bases in Japan, the United States and Europe, backed by first-rate R&D capabilities, Santen aims to increase corporate value to become a world-class company that delivers unique products to patients worldwide. Santen is headquartered in Osaka Japan - to learn more about Santen USA, the new Global Headquarters for Clinical Development & Medical Affairs where this job is headquartered, please visit http://www.santeninc.com To learn more about us: Go to http://www.santen.com/ Santen Pharmaceutical Co. (Parent Company, Osaka, Japan) Santen Ltd. http://www.santen.co.jp/ Santen Europe http://www.santen.eu/ United States Santen Inc. - http://www.santeninc.com/ Additional Information Posted: June 13, 2012 Type: Full-time Experience: Director Functions: Science, Strategy/Planning, Writing/Editing Industries: Pharmaceuticals, Biotechnology Compensation: Based on experience level Job ID: 3193180 ___________________________________________ See other Santen positions located in Emeryville with access at http://www.santencareers.com/search-jobs/ Sr. Network Engineer (Regular Full-Time) Location: Emeryville, CA Position Details Sr. Network Engineer (Contractor Approx. 3-6 mos.) Location: Emeryville, CA Position Details Senior Technical Developer / Enterprise Architect, Information Solutions Location: Emeryville, CA Position Details Sr. Analyst, Clinical Finance ***REVISED*** Location: Emeryville, CA Position Details Pharmacoepidemiologist (Contract) Location: Emeryville, CA Position Details ********************************************************************** To apply for this position, please send your resume and cover letter to: [email protected]

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Sr. Product Marketing Manager Entelos - San Mateo (San Francisco Bay Area) Job Description We are currently seeking a talented and experienced product marketing professional with a demonstrated track record of success to join our team. The Sr. Product Marketing Manager will drive the development and implementation of product positioning and go-to-market strategies. This role will also be responsible for driving sales enablement including marketing collateral, pricing models and sales tools to support the company’s rapid growth. Essential Duties:

Develop, drive and coordinate marketing activities and policies to promote products and services, working with advertising and promotion providers

Manage software requirements process to ensure product documentation meets market needs and supports development team on-time and on-spec delivery

Perform thorough market research and competitor analysis to understand and develop a competitive strategy for the marketplace

Develop and implement effective go-to-market strategies Identify and monitor new market opportunities and provide supporting justification to

pursue these opportunities Coordinate and participate in promotional activities and trade shows, working with

developers, advertisers, and production managers, to market products and services Initiate and manage technology and marketing partnerships Recommend development of product offerings, product features, and related services to

ensure attainment of market penetration and financial objectives Partner with senior leadership across product management sales, and corporate

marketing to drive consistent positioning and messaging Manage relationships with various regulatory bodies such as the FDA to ensure software

and instrumentation adheres to US and worldwide regulations Desired Skills & Experience Required Skills and Experience:

Minimum 8 years of related product or solutions marketing experience, preferably at a technology company

BA/BS in marketing or related field Demonstrated ability to lead marketing strategy in a fast-paced, fluid, cross-functional,

unstructured environment Proven track record influencing and communicating product offerings to customers,

prospects, sales people, industry analysts and trade press Self-driven, with a positive outlook and ability to motivate resources and peers Hands-on customer experience Excellent writing, business/financial, organization, project management and

presentation skills Highly Desirable:

MBA or experience with a top-tier consulting firm Experience marketing analytic products to R&D organizations of large Pharma

companies Media-trained and/or experience speaking in front of large groups

We offer competitive compensation and benefits and a creative work environment. Entelos is an Equal Opportunity Employer. Proof of eligibility to work in the United States is required. ********************************************************************** Apply on company website

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Senior Scientist Development – Clinical Informatics Genentech - San Francisco Bay Area Job Description Passionate About Science We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases. The following opportunity exists in our South San Francisco, CA, headquarters: Senior Scientist Development – Clinical Informatics Responsibilities: Genentech seeks a highly motivated informatics Senior Scientist/Scientist to lead and support biomarker data analysis within the Oncology Biomarker Development (OBD) group in gRED. The incumbent is expected to leverage extensive computing infrastructure and existing pipelines to build and maintain quality controlled, data analysis, storage and reporting pipelines focused on state of the art molecular biomarker analysis platforms (e.g. next generation sequencing, mass spectrometry or reverse phase proteomics). A second focus will be translating complex biomarker data into useful diagnostic tools that can guide the understanding of drug activity in patient tumors or the identification of subsets of patients who may benefit from therapeutic intervention. The successful candidate is expected to closely collaborate and partner with biomarker, clinical and statistics scientists in early development, participate and contribute to team meetings, publish in high quality scientific, technical or medical journals, present at meetings and drive novel innovative informatics and data analysis strategies. The incumbent is expected to coordinate and enable data sharing/exchange and engage in collegial collaborations with scientists in the Bioinformatics Research department. The Senior Scientist/Scientist will report to the Director of OBD-Dx within the Development Sciences Division of Genentech Research and Early Development. The individual will lead data analysis strategies for programs in both OBD predictive diagnostics (Dx) and pharmacodynamic (PD) groups. A key responsibility of this role will be to coordinate and engage with scientists and colleagues in the Bioinformatics Research department to enable the appropriate utilization of databases and analysis tools. Desired Skills & Experience A PhD in a relevant scientific field (molecular biology, bioinformatics, statistics, computer science etc.) is required. The candidate must have exceptional hands on informatics and data analysis expertise to biomarker scientists in OBD. He/she must identify and develop prediction algorithms based on complex genomic data. Passionate About Our People We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life. Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. To apply for this job, visit https://roche.taleo.net/careersection/10000/jobapply.ftl?lang=enandjob=00396357andsrc=JB-12000 Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer. Company Description At Genentech, we are passionate about finding solutions for people facing the world's most difficult-to-treat conditions. That is why we use cutting-edge science to create and deliver innovative medicines around the globe. To us, science is personal.

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Additional Information Posted: June 11, 2012 Type: Full-time Experience: Mid-Senior level Functions: Science Industries: Biotechnology Job ID: 3185626 ******************************************************************** If interested contact David Obad at 415.738.7878 x 104 David Obad NCompass Recruiting Services www.ncompassinc.com Office: 415.738.7878 x 104 Subject: NCompass | Sr Manufacturing Process Engineer opening (balloon catheter) I am in search of a Sr Manufacturing Process Engineer that has balloon catheter experience. My client is a publicly held medical device company located in Sunnyvale. ********************************************************************* Sterling Life Sciences Positions in northern California. Check out this recruiter listing at http://www.sterlinglifesciences.com/index.html. This is my first contact with this group so can’t comment on them. Some listed include: Clinical Research Coordinator - Biopsy Our client is a leading privately held CRO that specializes in providing services in the dermatology, skin care and beauty industries Clinical Research Coordinator – Instruments Our client is a leading privately held CRO that specializes in providing services in the dermatology, skin care and beauty industries. Clinical Research Coordinator - Safety Our client is a leading privately held CRO that specializes in providing services in the dermatology, skin care and beauty industries. Clinical Operations Manager Our Client is a leading privately held CRO that specializes in providing services in the dermatology, skin care and beauty industries. Clinical Operations Manager Our Client is a leading privately held CRO that specializes in providing services in the dermatology, skin care and beauty industries. Global Clinical Project Manager Our client is a leading privately held CRO that specializes in providing services in the dermatology, skin care and beauty industries. Clinical Research Assistant, Clinical Pharmacology Our client is a leading pharmaceutical company. Clinical Trials Manager Our client is a leading pharmaceutical company. ************************************************************* Contact Carolyn Jones, Recruiter [email protected] Work:407-898-4440 X 105

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View open Jobs: @Legacymedsearch.com Job #559-MH2620 Job Title: Director Business Development Cardiovascular Location: Philadelphia, PA Click here to apply (mobile compatible) Director of Business Development - Cardiovascular Implantable Devices Search re-opened 6-1-2012 Our client is a leading implantable biomedical device technology company, with a broad portfolio of engineering design, development and manufacturing expertise for implants used in surgery. The Director of Business Development will leverage current, active professional relationships within the MedTech and Healthcare industry along with his/her engineering and product development knowledge to sell design, development and technology consulting services. -------------------------------------------------------------------------------- PRIMARY RESPONSIBILITIES

Provide business development leadership for surgical cardiovascular business segments, all within the medical industry, to grow business opportunities and revenue

Work closely with the engineering staff to support a wide range of business development activities to support products used in the operating room and cath lab.

Develop and execute transactions to support the business by performing market analysis, identifying targets, presenting the opportunity and structuring/negotiating deals

Work with General Manager to develop strategies for marketing and selling, client identification, client screening

Develop relationships with primary decision makers on the project initiation level EDUCATION REQUIREMENT Bachelor's Degree in Engineering or related field (Required) Master’s degree - MBA preferred EXPERIENCE REQUIREMENT

Minimum of 5 years of business development / sales experience with a consulting, design and development services company or sales experience with a medical products company

1 year minimum prior experience as a product development, research, or design engineer within a medical based company (manufacturing, development, OEM, R&D consulting services, etc)

National or Global Contacts with Decision Makers in the Medical Technology Industry Proven "deal-maker" leadership skills with track record of successful closed transactions

(and documentable income in excess of $100,000) Unrestricted authorization to work in the United States 50% to 70% domestic and international travel Powerful presentation abilities working with Engineers, Senior-Level executives, including

Accounting & Finance, to generate 15+ major proposals per year generating several million dollars in consulting and technical fees.

***Prior experience as an engineer within a medical device or medical-based consulting company is required and you will need to be able to demonstrate your individual contribution to the design of a medical product to demonstrate the base-line proficiency in engineering necessary to succeed in this upstream business development role. This is a high profile, high level sales position for a highly regarded company with global range and influence and you must have significant contacts and the ability to open doors for our client. ***************************************************************************

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Please check out our website, www.bionexsolutions.com, and then send your resume to [email protected]. Electrical Engineer Opportunity BioNex Solutions, is an emerging life science instrumentation company focused on the unmet needs of customers in the lab automation and liquid handling markets. We're seeing a talented Electrical Engineer to complement our outstanding Development Team. Candidates must have at least 3 years' experience in the design and development of electrical assemblies for automation devices, experience with MS Visio, Altium Designer, Orad, or other CAD package, and 24 VDC logical and controls. This equity position is an outstanding opportunity to be highly impactful in an innovative, team-oriented environment. ************************************************************************ CONTACT: Janet Jarboe, Principal FOR JOB DESCRIPTIONS Jarboe & Associates [email protected] 970-686-5899 (OFFICE) 970-689-2962 (MOBILE) SERVING PROFESSIONALS SINCE 1997 - CONFIDENTIAL SERVICES Head of Business Development - S CA Strong leadership and management skills Must provide a deal sheet A strong work ethic and ability to lead multidisciplinary teams A combination of PhD (preferably in a biological discipline) and MBA is most desired At least 10 years experience in business development, financial modeling, or quantitative marketing A strong track record in identifying opportunity, negotiations, closing business and licensing deals A track record demonstrating strong analytic skills in market assessment, valuation, IP analysis, and technical analysis Familiarity with use of business and financial databases, and analytic methods Strong communicative skills, ability to rapidly generate MS Excel and Powerpoint based presentations and effectively present to Sr. Management. Ability to generate accurate and timely budget Other desirable qualifications: 1) Demonstrated strong personnel management skills 2) Experience in diagnostics 3) Knowledge of CPT and disease coding 4) Familiarity with Laboratory, Marketing and Sales organizations 5) Familiarity with Pharma organizations Manager, Quality Assurance - CO or CA *Strong technical, analytical and writing skills to identify and solve problems and document them appropriately. *Ability to exercise independent judgment in making decisions to assure product quality. *Working knowledge of drug development process, FDA/EMA/ICH guidelines and GMPs, especially as applied to small molecule development, IV and oral dosage forms. *Working knowledge of validation as applied to pharmaceutical manufacturing, testing and equipment. *Working knowledge of preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World. *Demonstrated project management experience and skills, with the ability to coordinate multiple projects in a demanding fast-paced environment.

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*Excellent oral and written communication skills for effectively interfacing with other departments within the company, suppliers, and other contractors. *Demonstrated audit conduct and management experience is desired. *Strong technical, analytical and writing skills to identify and solve problems and document them appropriately. *At least five years experience in a quality role within a pharmaceutical development setting required. *A degree in Pharmacy/Pharmaceutical Sciences, Chemistry, Analytical Chemistry or related scientific discipline is desirable. *Expertise in the areas of CMC, Quality and Regulatory. *This is an office based position with some travel. Manager, Statistical Programming - CA BS Degree (MS preferred) in Computer Science, Biostatistics, Statistics, or a related quantitative discipline. Minimum of 10 years (12 years preferred) of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Additionally, the successful candidate must minimally possess abilities in the following: Knowledge of using SAS/Base, SAS/Macro, SAS/STAT, SAS/Graph, and SAS/SQL in a windows environment to develop and validate analysis datasets, tables, listings, and figures/graphs. Ability to clearly communicate processes and standards with management and team members. Constructing technical programming specifications. Working in a team environment. Leading projects and teams. Knowledge of CDISC SDTM and ADaM models and experiences in transforming raw data into those standards. Knowledge of: Relational Databases, Good Clinical Practices, Good Programming Practices, 21CFR Part 11 Standards, Integrated Summary Safety/Efficacy Analyses, NDA/ BLA submissions, Safety data and Coding Dictionaries (MedDRA and WHODD), Creating all documents necessary to support an electronic submission in the eCTD format. Biostatistician / Sr. Biostatistician - S CA Ph.D. in statistics/biostatistics with at least 2 years experience

OR Master's Degree in statistics/biostatistics Oncology clinical trials experience. Pharmaceutical/biotechnology experience is a plus. Sound knowledge of theoretical and applied biostatistics. Sound understanding of regulatory guidelines in a pharmaceutical research setting. Good verbal and written communication skills. Demonstrated ability to read, analyze, and interpret scientific and technical journals,

statistical texts, government regulations, financial statements, and legal documents. Ability to respond to inquiries or complaints from customers, regulatory agencies, or

members of the medical community. Proficiency in writing articles for publication, presentations, operating procedures,

procedure manuals, and business correspondence. Ability to effectively present information to top management, public groups, and/or

boards of directors. Proficiency with explaining statistical concepts and results of data analyses to non-

statistical audiences and project team members. Good organizational and problem-solving skills Detail oriented, self-motivated with ability to multi-task.

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Demonstrated ability to comprehend and apply principles of advanced calculus, modern algebra, probability and advanced statistical theory.

Ability to work with concepts such as probability distributions, limits, rings, quadratic and differential equations, and proofs of theorems.

Mastery of at least one statistical programming language (e.g., SAS, S-Plus). Proficient with Microsoft Word, Excel and PowerPoint. Knowledgeable with the concepts of database structure. Ability to work with data processing, programming, systems design, problem, analysis,

and hardware. Clinical Operations Systems Manager - CA •8-10 of experience in a pharmaceutical or biotechnology company •2 years of direct document management experience •3 years of CTMS management experience •Excellent knowledge of U.S. regulations governing clinical trials •Ability to direct, coach, develop, and manage the document control team •Excellent verbal and written communication skills •Must possess sound judgment and discretion and be detail orientated •Ability to think independently, creatively and proactively propose solutions •Strong analytical skills •Computer literate; Knowledge of word-processing and spreadsheet applications •BS degree or equivalent work experience

Clinical Supply Coordinator - CA •3-5 years experience in a GXP environment •3 years experience in clinical supply management •Experienced with MicroSoft Office Platform •Experience in working with CMOs in a virtual environment •Attention to detail •Willing to learn and gain experience •Self motivated and organized •Working knowledge of IV/IWRS a plus •Degree in a science or pharmaceutical related field or supply chain management or related experience Product Manager, Marketing reporting to the Brand Marketing Director - CA •Four years’ marketing experience in pharmaceuticals or biotechnology •Previous marketing experience collaborating with a sales force •Launch experience in the last 2 years highly preferred •Prior marketing experience working with a co-promotion partner •Oncology and urology marketing and/or sales experience •Knowledge of the prostate cancer disease state and key opinion leaders in oncology and urology •Self-starter with excellent interpersonal skills, decision-making capabilities and demonstrated problem solving skills •Adaptable to changing roles/responsibilities required in a fast-paced, rapidly growing company •Proven ability to work with cross-functional team members •Excellent communication skills are essential Education: •BA/BS required. MBA or advanced degree preferred Brand Director, Breast Cancer Services - S CA (Ph.D. or M.D.)

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- MBA or Equivalent or MD or PhD required. -Undergraduate degree in biological sciences, prior experience in a molecular diagnostic or life science tools company with strategy / market research focus. -Previous position in the field of breast cancer diagnostics a huge advantage. -Previous working experience in breast cancer treatment market an advantage. -A Minimum of 8-10 years experience, with demonstrated ability in broad range of areas including, but not limited to marketing; health care sales, strategic planning; market research, business development; financial analysis; and financial modeling required. -Excellent verbal and written communications, analytical, organizational and interpersonal (teamwork oriented) skills required. -Must have strong presentation skills. -Strong leadership capabilities, particularly influencing in a complex matrix organization and motivating teams across divisions, cultures and time zones. Associate Director/Director, Clinical Pharmacology - MA (PharmD, PhD, MD) •PharmD, PhD or MD/PhD with 7+ years of industry experience in an area relevant to clinical pharmacology •Demonstrated accomplishments in experimental design, regulatory considerations and clinical execution of clinical PK/PD studies •Strong data analysis skills and an in-depth knowledge of pharmacokinetic and pharmacodynamic principles, including their application in clinical research and drug development. •Comprehensive understanding of clinical regulatory requirements and knowledgeable in ICH and GCP guidelines •Ability to produce and present quality scientific presentations at internal or external meetings. •Excellent verbal and written communication and presentation skills •Demonstrated ability to work effectively in a matrix, team environment, manage multiple priorities and exercise sound judgment •Title will be commensurate based on experience *************************************************************************** . Please send your resume to [email protected]. We are an equal opportunity employer. BioCardia® is a growing medical device company on the mid-peninsula. We are developing revolutionary catheter delivery systems for cardiovascular regenerative medicine. We have also leveraged our core technology to create and grow a vascular access product line used by interventional cardiologists, vascular surgeons, and interventional radiologists. We are building our technical team and are seeking exceptional leaders to join our innovative team of engineers and scientists. This is a unique opportunity to develop and launch ground breaking technology.

MANUFACTURING ENGINEER RESPONSIBILITIES:

Design and develop product changes and enhancements consistent with a zero defect level and low product cost.

Design line layout, utilizing lean manufacturing techniques.

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Design and develop testing methodology. Coordinate process validation efforts. Conduct process based risk analysis. Propose and implement risk minimization actions and controls.

Design, develop, and implement manufacturing fixturing and tooling in coordination

with QA and R&D functions.

Oversee training of manufacturing staff. Coordinate the work of assigned technicians and temporary workers as needed.

Work with R&D Staff to design optimally manufacturable products.

Provide engineering and technical support of products introduced into both the domestic

and international markets.

Oversee maintenance of company facilities and equipment. QUALIFICATIONS:

BSME or equivalent is required 2 – 5 years experience in the medical device industry is also required as is a

background in catheter design and production Must have strong analytical, problem solving, communication, and interpersonal skills Experience with equipment or mechanical design is preferred as is the ability to use

standard machine shop equipment Proficiency with 3D modeling software is strongly preferred

We offer a competitive compensation package including health insurance, stock options and a challenging work environment **************************************************************************** Sales Rep - Pain Management/Wound Care - Northern Los Angeles Now hiring: Sales Rep - Pain Management/Wound Care - Northern Los Angeles http://www.ziprecruiter.com/job/Sales-Rep-Pain-Management-Wound-Care-Northern-Los-Angeles/0e4ebcf1/?source=social-linkedin-group-jobs *********************************************************************** Senior Manager/Associate Director, Data Management – Full Time Position (San Francisco Bay Area) To view this and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. *Current U.S. work permit status required. No VISA sponsorship provided. DESCRIPTION: The Senior Manager, Associate Director is responsible for overseeing all Data Management (DM) operational activities ensuring compliance with the corporate timeline and scope of work outsourced to the DM service provider (SP) and coordinating activities from other external vendors that may also provide study data. This includes but is not limited to vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all DM services from study start-up through study close-out and final reporting. This position reports to Head of Biometrics.

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Specific Duties • Participate in vendor and technology (e.g., EDC) evaluation, qualification and selection. Involved in RFP development and contract negotiation, as needed. • Oversee and manage all DM related activities outsourced to DM SP as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget. • Participate with the Study Operations Teams (SOTs) for all study activities, and lead all DM functional activities using established FGN templates/processes as applicable (e.g. FGN DM standards include CRFs, Completion Guidelines, edit check specifications, metric/status reports, transfer agreements, DMP template, medical coding conventions, etc.). • Provide operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring established standards. • Review study data for completeness and general clinical sense. Assess the overall quality of data and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., increased frequency of queries, protocol deviations, and early treatment discontinuations. • Develop and manage the data review plan for each assigned study, including maintenance and tracking of findings from all team members through issue resolution and involving the data vendors as needed. EXPERIENCE AND QUALIFICATIONS: • Bachelor’s degree in a relevant scientific discipline or equivalent • Minimum of ten years of relevant clinical experience in the pharmaceutical, biotech and/or CRO industries, or equivalent • Skills present in core data management activities (e.g., Data Management Plans, data edit specifications, understanding of database dictionaries/specs, electronic data transfers, efforts/process in data quality assurance, use of medical coding dictionaries). CCDM Certification a plus • Knowledge and experience with various clinical databases (e.g., Clintrials, Oracle Clinical, SAS) and key technologies (e.g., EDC, Scanning/Imaging, IVRS/IWRS) • Knowledge of FDA regulations, GCP, GCDMP and ICH guidelines required • Excellent communication, written and interpersonal skills • Self sufficient and able to work with minimal oversight • Demonstrate leadership skills and the ability to lead teams and motivate team members, as needed • Able to prioritize and handle multiple tasks and studies simultaneously • Able to manage direct staff, as needed. Ability to develop project management objectives and manage performance reviews, as needed • Proficiency with MS Word, Excel, Outlook, and PowerPoint, SAS programming a plus • Must be willing to travel as required To apply for a position send your resume to [email protected] ************************************************************** Apply on company website Senior Business Solutions Program Manager Actelion - South San Francisco (San Francisco Bay Area) Job Description Position Summary To provide program management leadership and business analysis services to facilitate the successful execution of Actelion Pharmaceuticals US business objectives. The role will plan,

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execute, and finalize projects and programs according to strict deadlines and within budget aligned to the Actelion business strategy. Additionally, they will be responsible for driving program execution while ensuring that the programs meet internal partner requirements. Primary Responsibilities Include the following. Other duties may be assigned

Lead multiple programs and projects across the Actelion US operations. Manage relationships with Actelion US and Global operations for the effective delivery of

Actelion US operations project portfolio. Define project scope, goals, and deliverables that support business goals in

collaboration with senior management and stakeholders. Create detailed plans, project milestones and deliverables. Lead program teams to meet the requirements of functional leadership to drive

program strategy. Track program progress against goals and communicate summary reports to Actelion

Senior leadership. Manage project personnel activities.

Facilitate program team meetings, develop meeting agendas, prepare and maintain project documentation (including developing and delivering project progress reports, proposals, requirements documentation, and presentations Desired Skills & Experience Qualifications This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requirements

Minimum 8 years of direct project and program manager experience supporting complex, multi-functional projects.

Bachelor of Science or equivalent degree required. At least 5 years in pharmaceutical or biotech industry with an understanding of

Commercial, Medical and back office operations. Prior experience in professional services organization strongly preferred. Project management certification preferred. Proven track record of successfully leading complex programs and projects. Superior communication (verbal, written, and presentation), organization and planning

skills. Strong interpersonal skills and ability to effectively work collaboratively and provide

leadership in a global matrix team environment. Proven success in management with demonstrated ability to supervise and motivate

large teams in a global matrix organization while building working relationships that foster teamwork and trust.

Evidence of effectively managing change and ambiguity as business needs change. Strong analytical and technical skills with the ability to analyze technical and business

processes and translate them into business requirements. Ability to identify and efficiently solve project issues. Skilled in organizing resources, establishing priorities, and managing cross-functional

dependencies. Proven influencing, facilitation, negotiation and conflict management skills. Ability to proactively mediate and encourage team discussion and debate. Experience in effectively managing vendors.

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Self motivated and able to work independently. Proficiency with MS Office and project applications.

Actelion provides equal opportunity to all qualified applicants and employees by prohibiting discrimination in employment decisions because of race, color, religion, sex, national origin, age, veteran status or disability and all other protected categories. EEO/VET Company Description Actelion Pharmaceuticals Ltd is a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, focusing on the discovery, development and commercialization of innovative treatments to serve high unmet medical needs. Actelion was founded on 17 December 1997 and is now a public listed company on the Swiss stock exchange (SIX). Additional Information Posted:

May 18, 2012 Type:

Full-time Experience:

Mid-Senior level Functions:

Project Management Industries:

Pharmaceuticals Job ID:

2907024 ******************************************************** Mike DeLaney, BSEE GNR - Global Network Recruiting President - Medical Devices & Instrumentation 888.338.9087 x113 [email protected] - ADD me as a LinkedIn connection www.gnr-corp.com DIRECTOR of QUALITY & REGULATORY AFFAIRS-Medical Implants! We are recruiting for a well established, international based company who?s offering a HIGHLY visible opportunity within their rapidly growing SENIOR LEADERSHIP Team for a ?Hands-On? DIRECTOR of QUALITY ASSURANCE & REGULATORY AFFAIRS! You will be responsible for developing, planning and managing the successful execution of RA & QA programs for their ?Specialty? high-precision medical implants. As part of the Executive Management Team you will report directly to the GM. Experience and knowledge of; -Strong leadership experience while taking a hands-on management approach.

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-Experience reviewing and establishing quality processes and procedures for a manuf./machining environment. Technical background needed. -In depth knowledge of standards (21 CFR Part 820, ISO 13485& 14971). BENEFITS: GENEROUS base salary w/ 20% bonus (totaling more than $160K!) + full relocation package! LOCATION: Northern Utah region - direct-hire / full-time Interested in hearing more details? Reply directly to [email protected] include REQID#2073 with an updated resume, email address and a convenient time/number to reach you. ********************************************************** For more info: Contact Corey at [email protected] Director of Reimbursement Operations and Customer Service Job ID: 301 | Location: California |Technology: Cardiovascular Job Description: A cardiovascular genomic diagnostics company located in Palo Alto, CA. Our client has developed a clinically validated genomic test to aid in assessing and tailoring care of individuals with cardiovascular disease, including coronary artery disease (CAD), cardiac arrhythmias, and heart failure. This is a great opportunity to be a part of one of the more compelling Cardiovascular technologies that are available today. In this role, the Director of Customer Service and Reimbursement Operations will be responsible for all aspects of the customer experience, providing top-notch support to our clinician customers, patients, and our field-based sales employees. The Director will interface extensively with internal departments including the commercial laboratory, quality, clinical research, and marketing. Responsibilities:

Depending on the timing of hire, the Director may lead the transition from our current vendors and processes to a new centralized vendor; cutover activities include designing, developing and documenting new reimbursement processes and procedures, performing training and communicating these changes to various impacted parties

Take ownership of all non-laboratory elements of the test result-to-revenue cycle, with a continual focus on process improvement and optimization

Work cross-functionally with the commercial management team to constantly improve the customer experience for patients and clinicians

Provide leadership and direction to staff members including training, development and performance management

Develop and review all reports to assess key business information that may require action, troubleshoot vendor issues and track the vendor’s progress against various deliverables

Communicate with both internal and external parties (such as the sales team) on various customer service issues as needed

Overall, the scope of the Customer Service and Reimbursement Operations functions are: Customer Service:

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Work closely with the commercial laboratory to receive and accession (perform data entry) patient samples, partner with our clinician customers to resolve missing or inaccurate information provided on test requisition forms, field questions and concerns about insurance coverage or patient financial responsibility for their test, distribute and track field inventory and provide support for the field-based Territory Managers. Reimbursement Operations: Manage a third-party vendor responsible for insurance claim submissions, appealing denied claims, patient financial services, and credit / collections processes. Minimum Qualifications:

BS/BA is required; concentration in business administration, health information management, financial accounting or other equivalent degree or equivalent experience is preferred

Strong technical understanding reimbursement operations processes such as claims submission, appeals, and credit and collections; Customer Service experience is preferred

Understanding of medical billing, healthcare laws, regulations and HIPAA requirements Strong interpersonal and leadership skills Minimum of five years of supervisory experience, preferably in molecular diagnostics,

biotech or pharmaceutical industries ******************************************************** To apply for a position send your resume to [email protected] Clinical Data Manager – Full Time Position (San Francisco Bay Area) To view this position and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. *Current U.S. work permit status required. No VISA sponsorship provided* DESCRIPTION: The Data Manager is responsible for managing the efficient collection, processing, and review of data from clinical trials. This position serves as a technical resource in the conduct of Phase I to Phase III Clinical Trials. • Directly manages staff and conducts recruitment and on-boarding; Oversees the work of direct reports to ensure on-time, on-target and within-budget results • Conducts regular one-on-one and any other staff meetings to ensure timely communication with direct reports • Select and implement internal thesaurus management system and select and oversee external thesaurus management vendor • Ensure consistency of classification within a study and across studies for the same compound • Set global classification conventions • Author study specific thesaurus management plan with classification conventions; Perform thesaurus classification of adverse events to MedDRA • Perform thesaurus classification of concomitant medications to WHO drug • Create and maintain thesaurus management SOPs, work instructions and template; Perform SAE vs AE reconciliation • Perform clinical data review consistency between medical history, adverse event and concomitant medication • Set global lab data conventions • Author study specific lab data management plan • Collect local lab ranges; Assign local lab ranges to local lab data and Perform conversion of local lab data to standardized reporting units • Select and oversee central labs

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• Author external lab data management plans and specifications • Receive test and production lab data transfers; Review central lab data transfers • Create and maintain lab data management SOPs, work instructions and templates • Perform clinical data review consistency between lab data and adverse event data • Provide technical assistance to the CDM, clinical, safety, medical and biostatistics departments - Thesaurus, central lab, and local lab management EXPERIENCE AND QUALIFICATIONS: • Excellent oral and written communication skills. • Understanding and familiarity of the drug development process. • Knowledge of execution of Phase I-III Clinical Trials. • Excellent knowledge of MedDRA and WHO drug coding dictionaries required • Basic knowledge of SAS dataset structure required, working knowledge preferred. • Excellent knowledge of local and central lab data required • 8+ years clinical development experience required. • 3 years management experience required. • Working knowledge of paper based/ fax based and electronic data capture (EDC) processes and software. • Working knowledge of adverse event and concomitant medication classification processes and software. • Master's Degree and 5+ years clinical development experience required; or • Bachelor’s Degree and 10+ years clinical development experience required. or • No degree and 15+ year clinical development experience required. ***************************************************************** Program Manager-Molecular Diagnostics (MDx) - Full Time or Contract Position (San Francisco Bay Area) To view full job description and other current positions please visit www.JGBBioPharma.com. Interested parties should contact [email protected]. *Current U.S. work permit status required. No VISA sponsorship provided. DESCRIPTION: The Program Manager for the Molecular Diagnostics (MDx) Business Unit manages the development of internally developed diagnostics products or companion diagnostics products co-developed with external partners. This responsibility requires involving departmental or cross-functional teams focused on the delivery of new products. Plans and directs schedules and may monitor budget/spending. Monitors the project from initiation through delivery. Organizes the interdepartmental activities ensuring completion of the project/product on schedule and within budget constraints. Has overall project management responsibility. In this role, direct people management responsibility is not required. Essential Functions: • Leads cross functional core team through product launch • Develops project plan and timeline • Coordinates with external Assay Partner teams to achieve project / product deliverables • Be the internal expert in PCP process and IVD project management. • Act as “mini GM” as leader of cross functional core team. • Act as communication liaison with Business Unit Management to assure deliverables are met, appropriate resources are applied and team(s) remains focused and engaged Competencies: • Facilitative leadership skills, particularly the ability to influence stakeholders in other functions over whom the Project Manager has no direct authority. Must be a highly-motivated

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driver able to complete tasks by leveraging relationships and established goals. • Has analytical skills, especially the ability to generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations. • Willingness to be flexible and adaptable in a complex, matrixed environment. The ability to adapt to changing needs and parameters caused by time, budget, or other constraints • Discusses and presents factual information to other members of the team. Ability to convey very complex information in both written and oral form. Actively and constructively contributes to core team’s efforts through networking within the organization and effectively communicating to MDx management. Able to influence others and gain acceptance and build consensus. • Ability to manage moderately complex projects and initiatives. • Acts as a mentor/role model for team members. • Demonstrates understanding of company’s external customer needs and how they affect business unit products and services. • Makes decisions that involve the consideration of complex issues. • Works autonomously and checks-in as decisions are made. EXPERIENCE AND QUALIFICATIONS: • The candidate will have 3-5 years of project management experience in IVD product development **** Experience with Device Design Control and biological/PCR based diagnostics is strongly desired • Working knowledge of design control and FDA QSR requirements • Microsoft Project Management skills • The candidate will have proven ability to execute through influence within a matrixed organization • The candidate will have an undergraduate degree in science or engineering. Additional advanced degrees are preferred but not required • In their repertoire, the candidate will be self-motivated & a driving force of execution in their current or past organizations • Experience working with external collaborators; Negotiations skills; Leading through influence • Strong written and verbal communication skills • Strong presentation skills • PMP certification is preferred To apply for a position send your resume to [email protected] Margaret Imperiale, Human Resources Coordinator www.JGBBioPharma.com Diagnostics Jobs jgbbiopharma.com Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to [email protected]. Then we can contact you if a good... ******************************************************************************** CONTACT & additional info: *** SEE www.fpccareers.com FOR FULL POSTING of this and other opportunities ***. Also, contact Ira Mann at [email protected] Principal Validation & Quality Engineers - Critical Utilities and Process Equipment - Biologics and Biopharmaceutical -Southern California Global Biologics leader undergoing an expansion of over 1 billion seeks Validation and Quality Engineers at multiple levels including Principal to lead in areas including the following:

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Top Challenges: 1) Lead / participate as a validation and quality expert in cross-functional teams related to process equipment and critical systems. 2) Validation of aseptic processes, filling equipment, lyophilizers, pasteurizers, washers, tunnels, WFI generation and distribution systems, filter presses, purified gases, CIP/COP systems and, inspection and packaging equipment. 3) Lead validation of depyrogenation ovens, autoclaves and other sterilization equipment 4) Perform development cycles for sterilization, cleaning/CIP and mixing/suspending/formulating 5) Lead implementing quality systems and quality change control process. 6) Conduct assessments of quality systems, identify and close gaps related to validation, compliance and divisional procedures. Salary: Base will be dependent on your expertise and should range from the 100’s into the 110’s. Also available is strong benefits, bonus and relocation Location: California Qualifications: 1) 8+ years of validation experience with specific demonstrable experience in validating aseptic processes, process equipment and critical systems. 2) Experience specific to biologics, biotechnology, plasma or biopharmaceutical. 3) BS Degree in Engineering or Science 4) Validation experience related to Computer System Validation for PLCs, Delta V, SCADA and electronic batch records desirable 5) Experience specific to tanks, P&ID, washers and tunnels 6) Project Management experience ***************************************************************************** ************************************************************************** Apply Here! http://jobsboard.biocareers.com/c/job.cfm?job=10360889&site_id=9326 Position Title: Associate or Full Specialist Company Name: University of California San Francisco

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The Diabetes Center at the University of California San Francisco is seeking an outstanding candidate as Associate or Full Specialist depending upon the finalist’s level of experience. The successful candidate will help generate complex DNA constructs for the purposes of generating transgenic, knockout, or knocking mice and also would be involved in gene targeting experiments in embryonic stem cells and screening of stem cells for homologous recombination or transgenic insertion events. **************************************************************** To Apply: http://hiring.at/doys4 Sr. Quality Control Specialist, Analytical Orange County, CA Established Orange County pharmaceutical company has an immediate need to hire a full time Sr. Analytical Quality Control Specialist. The Sr. QC Specialist will perform sampling and testing to support manufacturing lot release, process development, reference standard qualification, validations and stability studies. The Sr. QC Specialist will also continuously work to improve and develop cGMPs and quality systems. Job Responsibilities: Adhere to written procedures and the high level of diligence during execution. Perform protein characterization, aseptic techniques, electrophoresis, chromatography, cell culture, LAL and assay validation and qualification. Write analytical, investigation and incident reports to be presented to technical audience. Perform accurate technical reviews of cGMP analysis, test methods, technical reports, validation protocols and other job related controlled documents. Perform aseptic sampling and pH measurements. Position Requires: Bachelors Degree in Chemistry or related and a minimum of 4 years of pharmaceutical industry quality control experience. Strong background in Analytical Chemistry required. Must have expertise in ELISA and HPLC. ******************************************************************** Contact http://theranos.com See list of Jobs at Theranos in Palo Alto:

Java Systems Architect – Theranos Java Systems Architect – Theranos Modeler – Theranos UI/UX Designer – Theranos Embedded Systems Engineer (OS) – Theranos Embedded Systems Engineer (RTOS/Firmware/Device Drivers)- Theranos .Net Software Developer – Theranos Java Systems Developer – Theranos .Net Systems Architect – Theranos Machinist Programmer – Theranos Manager QA/QC – Theranos Manufacturing Engineer – Theranos Mechanical Engineer – Theranos

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Contact Janet Jarboe at 970-686-5800; [email protected] • Manager, Statistical Programming - CA • Biostatistician / Sr. Biostatistician S CA • Clinical Operations Systems Manager - CA • Clinical Supply Coordinator Position - CA • Product Manager, Marketing - CA • Market Access Account Executive – 2 positions: West & Midwest • Brand Director, Breast Cancer Services - S CA PhD / MD • Associate Director/Director, Clinical Pharmacology - MA PharmD / PhD / MD

**************************************************************** Ruchika Raval President, Global Biopharm Regulations Inc [email protected] I need a person with 5-7 years expertise in CMC writing. Familiar with eCTD format. Knowledge of biological CMC processes an advantage. The assignment is for 4 weeks and in the bay area. *********************************************************************** Application: To apply please send CV/Resume to [email protected] Technical Marketing/Product Manager BioGenex - San Francisco Bay Area Job Description Job: Technical Marketing/Product Manager Job Summary: BioGenex has an opening for a Technical Marketing/Product Manager committed to global molecular medicine in the area of advanced automated molecular diagnostic projects for diagnosis, prognosis and therapy selection of cancer. Principal Responsibilities:

Drive all Marketing Efforts Maintain broad knowledge of state-of-the art molecular biology and oncology field Heavy emphasis on the reagents product line Act as the spokesperson to drive product awareness, interest and preference Work closely with R&D team members to successfully develop products Development of marketing strategy, messaging and content Manage product life cycle, which includes pricing analysis and direction on

discontinuation of product line Presentation at internal and external launches, seminars, sales training and marketing

programs Partner closely with sales team to offer positioning and pre-sales solutions

Desired Skills & Experience Preferred Qualifications:

MBA, Masters or Ph.D. in Cell Biology, Molecular Biology, Biochemistry, or related field 2 to 3 plus years of experience in an industrial environment and/or post doctorate work. Product launch experience Experience with laboratory techniques including immunohistochemistry, FISH, and in

situ hybridization is a plus Solid knowledge of immunology, molecular biology, histopathology and virology First-hand experience of immunohistochemistry and in situ hybridization Experience with miRNA is a plus Excellent verbal and written communication and presentation skills

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Publication and presentation experience Good network presence in the scientific community Experience with PC-Based software including MS Word, Excel, PowerPoint, Outlook, etc.

Company Description BioGenex is committed to advancing the pace of molecular medicine and diagnostics. We support cellular and molecular pathology laboratories with a range of IHC, ISH reagents, detection kits, antibodies, probes and automated staining for automated immunohistochemistry. Our state-of-the-art automated systems are designed for high throughput IHC, ISH, FISH, miRNA at a low cost of ownership. They provide consistent, quality results with ease of use and maximum flexibility for clinical diagnostics, life science research and drug discovery. Our customers include reference laboratories, hospitals, cancer treatment centers, university medical institutions, large and retail practice groups. Further, we continue to partner with life sciences industries and academia driving molecular drug discovery and translational and clinical research. Our passion for sustained and leading edge innovation helped us to develop strong research and development skills and improve our product and service offerings. Our intellectual property includes several U.S. and foreign-issued patents, in the areas of DNA labeling and amplification techniques, automation of tissue and cell sample preparation, automated staining for nucleic acid, immunohistochemistry (IHC), special stains, antigen and nucleic acid retrieval techniques. Additional Information Posted:

June 7, 2012 Type:

Full-time Experience:

Mid-Senior level Functions:

Marketing Industries:

Biotechnology Job ID:

3164606 *********************************************************************** Apply on company website Vice President, Marketing Fluidigm Corporation - San Francisco Bay Area Job Description Reporting to the Chief Business Officer, the Vice President of Marketing will be responsible for the strategic and tactical marketing functions at Fluidigm. This individual will drive the development of Fluidigm’s overall product marketing strategy, as well as manage the classical marketing functions of product marketing, communications and public relations. This person will also play a significant role in corporate branding and positioning. S/he will lead these functions and will direct an organization of 10+ people to carry out these responsibilities. The successful candidate will build a marketing organization that will be a strategic asset of the company.

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ESSENTIAL DUTIES AND RESPONSIBILITIES: · A member of the executive team of the company, representing the functions that specify new product and service offerings, drive execution of their development and effective promotion, and generate interest and opportunity for the sales organization sufficient to ensure growth as required by the company. · Develop and lead the execution of marketing plans that drive increased market size and share for Fluidigm's products. · Supervise the leaders of product and program marketing teams. · Develop creative and actionable value propositions for targeted segments that will generate sustainable and superior financial performance. · Create unique and compelling positioning for Fluidigm’s products via advertising, marketing and promotional efforts. · Strengthen and expand relationships with customers by providing valued-added services. · Create a best in class marketing function at Fluidigm through acquiring and developing marketing talent and developing the department’s methodologies, processes, and procedures. · Present strategic options to the executive management team in order to expand the business and sustain growth and profitability. Desired Skills & Experience - Experience leading the marketing function at a LEADING life sciences COMPANY or in a closely related technology domain. - Prior experience in managing product managers, communications programs, and commercial processes in a capital goods environment required. - Demonstrates sound business judgment: has outstanding record of good decisions; shows excellent analytical process; understands consequences of actions; has good intuition. - Is self-motivated; seeks additional assignments; manages multiple projects simultaneously. - Recommends and champions new methods and ideas; accepts new ideas and builds on them; learns quickly; has high degree of curiosity relating to marketing; adds value to a given situation; does not accept the “status quo.” - Excellent verbal and written communication skills: conveys ideas effectively; tests effectiveness of communication; determines most effective method of communicating; conveys ideas to the appropriate people; is a good listener. - Experience in direct selling role highly desirable. - Experience in global business highly desirable. - Experience in genomics and cellular science highly desirable. Company Description Fluidigm Corporation develops and manufactures complete systems based on its patented microfluidic valve technology that revolutionizes life-science research. Fluidigm’s product portfolio includes application specialization in gene expression, genotyping, and protein crystallization. Based in South San Francisco, Fluidigm offers an exciting, collegial working environment with excellent compensation and benefits, including pre-IPO stock options. Additional Information Posted:

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May 31, 2012 Type:

Full-time Experience:

Executive Functions:

Marketing Industries:

Biotechnology Employer Job ID:

375 Job ID:

3122825 ******************************************************************** Apply on company website Senior Director, Marketing (Women’s’ Health) Depomed, Inc. - San Francisco Bay Area Job Description Senior Director, Marketing This position reports to the Vice President of Marketing and is accountable for product strategy development and tactical execution across professional and consumer marketing efforts for Depomed’s growing Women’s’ Health franchise. Additionally, this person will lead and/or participate in the development of product life-cycle management plans, as well as high-level facilitation and communication with Sales Management to ensure field goals are supported with brand strategy and tactics. Requirements: · Lead the strategic development behind the professional & consumer marketing plans for Serada and other Women’s Health products Depomed may be selling · Responsible for leading and directing cross-functional team members (i.e.Medical, Regulatory, Promotion, Advertising Agency, Sales Operations, etc.) in the development of strategic and operational plans · Utilize strong communication skills to effectively communicate the marketing plan to the entire commercial organization · Develop and manage forecasts and budgets · Participate in the development and management of key customer and thought leader relationships · Compliance with Depomed internal processes regarding legal, regulatory and financial policies and procedures · Assess and develop marketing talent while coaching to achieve targeted results · Maintain a comprehensive and current understanding of relevant therapeutic markets, · Engage with internal customers on a consistent basis to bring an additional layer of strategic thinking and research expertise · Lead andsupport initiatives to improve the Teams processes and tools · Develop, manage, and track the Serada Marketing budget. Desired Skills & Experience Core Competencies: Team Management / Leadership skills: Articulates a clear direction and demonstrates the ability to motivate and positively influence others. Effectively manages people, projects, and budgets. Clearly defines performance standards for employees and gives recognition when appropriate. Ensures employees have clear measurable goals aligned with organization’s priorities and holds people accountable for results. Addresses performance and behavior issues

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in a timely manner. Inspires people to excel by modeling excellence and enthusiasm. Empowers teams to solve problems and initiate improvements. Identifies organizational needs and attracts, selects and retains talent. Decisions and Judgment: Gathers relevant information systematically and considers a broad range of issues or factors when making decisions; grasps complexities and sees the relationship among problems or issues. Uses a mixture of analysis, experience and judgment to make timely and effective decisions; evaluates results in order to improve future performance. Willing to make difficult business and personnel decisions and accept responsibility; decisions are timely, fact-based and well-reasoned. Teamwork/Collaboration: Establishes and maintains cooperative and productive working relationships with coworkers. Proactively and constructively resolves disagreements. Demonstrates support of team and companygoals. Provides unsolicited assistanceto others. Shares recognition and credit with others. Acts with integrity and earns the trust of others by dealing with them respectfully and honestly. Shows awareness and considers the opinions of others. Required Education, Experience, & Competencies:

Bachelor’s Degree Required; preferably in Life Sciences or Business, with an advanced degree in Business or Science strongly preferred.

Demonstrated experience and success in the area of direct to consumer (DTC) and direct to patient (DTP) marketing.

Minimum of 12 years of applicable pharmaceutical marketing experience with a minimum of 5 years of management experience.

Demonstrated leadership skills and ability to manage complex processes and initiatives. Experience and the desire to work within a fast-paced department is required. Action-oriented with strong sense of urgency; responsive to others; meets service

expectations of others. Results driven; highly organized with strong ability to follow through, prioritize and

execute agreed upon plans without supervision. Leads by example; does what it takes to get a job done; enthusiastic and positive. Effective communicator – both oral and written; is clear, complete and consistent. Listens effectively; customer focused; establishes effective relationships to gain trust

and respect. Innovative; offers suggestions on ways to improve processes. Strong knowledge of Microsoft Word, Excel, and PowerPoint. Excellent organizational and time management skills.

Company Description At Depomed our employees are passionate about creating great. Since our founding in 1995 we've worked hard to create a great specialty pharmaceutical company with great products. Our expertise and hard work has led to FDA approval and commercialization of our two marketed products, Gralise and Glumetza, a pipeline with late-stage product opportunities, and the development of our Acuform™ delivery technology, a unique, patented, polymer-based technology designed to optimize drug delivery. We are currently seeking a Senior Director, Marketing to join our great team in Menlo Park. *Note- Some relocation assistance will be offered to the right candidate. Depomed is an Equal Opportunity/Affirmative Action Employer. Thisis a direct full time hire- No agencies please. Additional Information Posted:

May 22, 2012 Type:

Full-time

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Experience: Not Applicable

Functions: Marketing

Industries: Pharmaceuticals

Job ID: 3070887

***************************************************************** Apply on company website Product Marketing Director, Chemical & Energy Freeslate Inc. - Sunnyvale, CA (San Francisco Bay Area) Job Description JOB SUMMARY: The Product Marketing Director will be responsible for developing and implementing a global marketing strategy for sales into Chemical and Energy market segments, identifying new product opportunities and current product improvements, creating effective marketing campaigns and promotional materials, and providing sales and internal product support. The position will report to the Vice President of Marketing and Strategic Planning. Up to 40% travel required. JOB RESPONSIBILITIES:

Ensure the voice of customer is represented in product development and product strategy at Freeslate for the Chermical and Energy market segments

Develop strategic and tactical plans to assure success in the Chemical and Energy market segments including identifying strategic opportunities and threats to Freeslate.

Define requirements and provide market input into a cross-functional process to conceptualize and execute new products

Manage all marketing aspects of product development projects, as part of a cross functional team, including market requirements, pricing strategies, financial analysis and sales forecasts, product literature and user information.

Define and execute product launch plans to include promotional plans, manufacturing forecasts, sales training plans, and support plans.

Formulate and continuously update value propositions for each market segment, with resultant positioning statements and major messages

Work with the sales organization to create and attain performance goals for the Chemical and Energy market segments

Provide product training and marketing support to field sales, applications and technical support personnel

Drive processes for identifying and rectifying product problems Create, approve and manage promotional plans, including product literature, trade

shows, space advertising, direct mail, web pages, newsletters, etc. REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

Bachelor's degree in chemistry, chemical engineering, or combination of equivalent education and work experience. Ph. D. preferred.

3-5 years marketing and/or product management experience ideally in the Chemical or Energy markets.

5-7 years overall work experience in a technically related field. Experience with automation is preferred. Demonstrated understanding of the chemical development process including a working knowledge of current pain points in discovering and developing new catalysts.

Experience in working with large chemical and petrochemical companies

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Understanding of the development of polyolefins and/or bio-based chemicals Experience in applying automation to scientific applications. Understanding of what is

critical for the success of an automated solution for chemical applications. PREFERENTIAL QUALIFICATIONS:

Successful track record defining customer requirements, reaching the customer (e.g. surveys, promotions, tactical marketing communications), working on product development teams, launching products and managing product life cycles.

Ability to analyze and dissect competitive information, market research, and customer data and use it to make sound recommendations.

A creative thinker with excellent written and verbal communication skills. Good organizational skills with the ability to prioritize and manage multiple projects

simultaneously. Ability to work effectively with cross-functional teams to achieve product launches

Freeslate is an Equal Opportunity Employer that is committed to diversity and inclusion. Our hiring decisions are made without regard to race, color, religion, creed, disability, genetic information, national origin, gender, gender identity and expression, age, sexual orientation, marital status, or veteran status. Company Description Freeslate is a privately held company of ~100 employees that provides products and related services for high throughput research. Based on its proprietary laboratory automation platforms, high throughput pressure reactors, and integrated Lab Execution and Analysis (LEA) software suite, the company enables dramatic gains in its customers’ productivity and innovation by delivering seamlessly integrated automation solutions. Freeslate leverages its scientific expertise through its team of Ph.D. scientists, engineers, and software developers with directly relevant experience in the industries it serves. Collaborating with customers for more than a decade, the business has provided high throughput research solutions for the pharmaceutical, chemical, energy, and consumer products industries. The company is headquartered in the heart of Silicon Valley in Sunnyvale, California, with direct sales and service in North America, Europe and Asia. We have comprehensive and competitive compensation and benefits offerings with a comfortable and collegial work environment. If you are interested in working with leading edge technologies with the brightest minds in high throughput research, Freeslate is the place for you. Submit qualified resumes to: [email protected] Additional Information Posted:

May 29, 2012 Type:

Full-time Experience:

Mid-Senior level Functions:

Marketing Industries:

Biotechnology Employer Job ID:

L74 Job ID:

3109215 ********************************************************

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Apply on company website Manager, Medical Writing Nektar Therapeutics - San Francisco, CA (San Francisco Bay Area) Job Description Summary: Oversees and maintains the relationship with contract research organizations. Evaluates and analyzes tools and processes to support outsourcing efforts. Contracts investigators for studies and ensures compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature. Typically travels to field sites to supervise and coordinate clinical studies, by monitoring schedules and clinical evaluation projects. Selects, develops and evaluates personnel to ensure the efficient operation of the function. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Essential Duties and Responsibilities: Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques. Reconfigure/renegotiate all contracts for all studies as needed. Serve as Clinical liaison to Legal to facilitate the proponent responsibility with the timely drafting, review, and processing of study-related agreements, CDAs, and contracts for study sites and vendors. Manage and track study-related payments. Manage and work w/ finance to process study-related invoices and ensure timely sign off by appropriate study managers. Contribute, as necessary, to study-related budgeting and coordinate data between the multiple departments for purchasing, finance, and legal departments. Work closely with Clinical and Project Management to ensure study supply plans are aligned with internal requirements. Proactively manage and resolve issues that may impact study timelines. Contribute to the development and implementation of departmental policies, standards and process improvement initiatives. May mentor and develop junior clinical staff. Desired Skills & Experience Minimum Qualifications and Requirements: A bachelor’s degree in clinical, biological or mathematical sciences or related field, or nursing qualification. A master’s degree is preferred. Equivalent experience may be accepted. A minimum of 8 years Pharmaceutical development experience with at least 4 years managing CROs is required. A minimum of 5 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong organizational skills. Excellent written and verbal communication skills are required. Experience and understanding of ICH, and GCP is required. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills. Advanced knowledge of Data Management processes and systems. Solid understanding of clinical drug development processes is preferred. Ability to develop data management processes and training is preferred. Previous people management experience is preferred. Must have effective problem solving skills. Company Description Nektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for NKTR-118, an investigational drug candidate, being evaluated in Phase 3 clinical studies as a once daily, oral tablet for the treatment of opioid-induced constipation. The agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of NKTR-118 and an opioid. NKTR-181, a novel mu-opioid analgesic molecule, is being evaluated in Phase 1 clinical studies. In oncology, NKTR-102, a novel topoisomerase I-inhibitor, is being evaluated in Phase 2 clinical studies for the treatment of breast, ovarian and colorectal cancers.

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Nektar's technology has enabled seven approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia. Nektar is headquartered in San Francisco, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com. Additional Information Posted:

May 29, 2012 Type:

Full-time Experience:

Mid-Senior level Functions:

Writing/Editing Industries:

Pharmaceuticals, Chemicals, Biotechnology Compensation:

Based on Experience Employer Job ID:

2686-525-R Job ID:

3108573 ************************************************ Jim Brown Associates 15 Southwind Circle Marina Bay – The Breakers Richmond, CA 94804-7405 Phone: (510) 235-4472 FAX: (510) 235-4482 e-mail: [email protected] Scientific Director – San Francisco It’s a health care marketing communications agency focusing on the biotech industry. Relationships Reports to VP, Scientific Services or Senior Scientific Director Job Summary The Scientific Director will hold the following core competencies: commitment to quality, management, leadership, team player, written and verbal communications skills, listening skills, and time management. Serving as a scientific liaison, this position is responsible for the development of editorial content, directing a team of medical writers and associate scientific directors, and maintaining the scientific integrity of all medical communication deliverables produced by the Company. Qualifications Advanced degree in the Life Sciences (MD, PhD or PharmD) from an accredited college or university. Residency and/or publication/writing experience or experience in medical or pharmaceutical field strongly preferred. At least 8 years relevant pharmaceutical and clinical experience, an in-depth understanding of one or more key therapeutic areas, including, but not limited to anti-infectives and oncology or an equivalent combination of education and experience.

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Publication/ writing experience or experience in medical or pharmaceutical field required. Willing to write/do some content development. Strong oncology background, hematological malignancies preferred. Prior experience mentoring and managing staff required. Advanced computer literacy necessary, including proficiency in Microsoft Office Applications such as PowerPoint and Word in addition to online medical resource searching (i.e. Ovid, Medline, PubMed, etc.) Candidates must have commercial experience in the above areas. Essential Responsibilities Department Management and Supervision

Conduct semi-annual performance appraisals for all direct reports in coordination with Director, Human Resources and VP, Scientific Services

Provide ongoing guidance and consultation to a team of medical writers and sr. medical writers and Associate Scientific Director

Makes recommendations and collaborates with HR on the training and development of medical writers and sr. medical writers

Develops, communicates, implements and monitors policies and procedures for the editorial services function in coordination with VP, Scientific Services

Recommend methods for improving the quality of editorial services provided to our clients

Editorial Project Management Direct the planning and execution of all editorial projects in coordination with VP,

Scientific Services Plan and coordinate project teams, work assignments, resource planning and allocation Determine deadlines and budgeted editorial hours for each project undertaken, either

from the relevant client service representative or senior editorial colleague Ensure assigned tasks are completed on time and within the time allocated in the

project estimate Communicate or warn when timelines are not likely to be met as well as suggest an

alternative arrangement if necessary Coordinate with client services and other colleagues to reach a consensus on content

and style for assigned editorial projects Contribute ideas to senior management to enhance productivity/competitive edge of

company By drawing on working knowledge of the different tools available for communicating

messages in the pharmaceutical industry, support project teams, contribute ideas, and share experiences

Play an active role in establishing a cohesive and dynamic relationship between the client services team, other editorial colleagues, and the client

Communicate regularly with editorial teams in other offices in order to share best practice ideas to achieve great efficiency

Coordinate at an appropriate level with external parties such as clients and key opinion leaders (e.g. liaising with speakers in the preparation of briefing notes and slide presentations)

Research and Information Management Maintains expertise and interprets new research findings in at least one area of

expertise and advises clients and internal staff on how new developments will impact the field

Predicts trends in at least one field of expertise Research medical and scientific topics utilizing various information services including in-

house reference system, on-line journal subscriptions, libraries, and literature search databases (i.e., Pub Med)

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Research and source appropriate medical literature for editorial projects and proposals (often within a tight timeline)

Efficiently and effectively use medical literature searching resources available within the company

General Writing Assist with development of concepts and planning for editorial projects Write and/or edit publication manuscripts, slide kits, monographs, newsletters, meeting

reports, posters, and other materials that utilize assimilated knowledge of specialized therapeutic area

Draft and edit work in different writing styles targeted at different audiences (including internal audiences) in different therapy areas. On all editorial projects, incorporate feedback from editorial colleagues, project team colleagues, and activity faculty

Review work for scientific accuracy Demonstrate an in-depth understanding of at least two key therapeutic areas Seek additional opportunities to develop skills in research, writing, and IT as well as

knowledge of specialized therapeutic areas Advise clients on the appropriateness and relative advantages/disadvantages of

presenting particular data in particular journals or forums Client Counsel and Relations

• Provide ongoing strategic and scientific consultation to clients • Monitor external competitor environment and scientific data. Report changes and

findings to clients as appropriate • Coordinate at an appropriate level with external parties such as clients and opinion

leaders (e.g. coordinating with speakers in the preparation of briefing notes and slide presentations)

• Facilitate client presentations, speaker briefings, etc. Professional Contacts

Identify, develop and maintain professional relations with key opinion leaders globally On-Site Meeting Attendance

React quickly to new data at scientific meetings and symposia quickly and formulate implications of this data in order to serve as a critical strategic consultant to clients on-site

Advise clients on the appropriateness and relative advantages/disadvantages of presenting particular data at particular meetings/symposia

Attend conferences, scientific symposia, and advisory boards Participate in on-site activities as deemed appropriate (e.g. front-of-house duties,

printing and duplicating slide-sets, running pre-meeting slide review with client or key opinion leaders)

Assist in the preparation of executive summaries and other deliverables from conference sessions in various formats and styles. This may include writing, editing, working with designers, proofreading, or liaising with faculty to gain copy approval prior to publication

Collect any relevant information available at on-site conferences (e.g., competitor information from exhibition stands)

Business Development Assist or take the lead in strategic identification, development, and writing detailed

grant proposals for new business Attend and present at meetings for new/maintenance of business where appropriate Seize opportunities for organic growth of business and advise senior strategic

colleagues of any potential opportunities for new business Help to identify opportunities to present capabilities of the scientific editorial

department Provide input and approve all editorial-related components of grant budgets

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Physical Requirements The physical requirements of this position are that of general office conditions and can include but are not limited to: working alone and/or with others, complex reading and writing, analysis and comprehension, judgment and decision making, seeing, hearing and listening, sitting for long periods of time, typing and verbal contact with others. Upon request, a reasonable accommodation may be made by the Company to enable individuals with disabilities to perform the essential functions. “We are an equal opportunity employer, committed to providing equal employment opportunities. We do not discriminate on the basis of race, religion, color, sex, age, national origin or disability." “This job description is not designed to entail a comprehensive list of position responsibilities required by the employee.” ************************************************************************** ************************************************************************* *************************************************************************

Other Information for Those in Transition ************************************************************************* *********************************************************************** Check out the annual Beyond Borders: Global biotechnology report 2011 on the biotechnology industry at www.ey.com. This is the 25th anniversary issue using consistent measures to track the industry sector. *************************************************************** Check out the CHI.org website for the most recent publications on the status and trends of the California Biomedical Industry and workforce. These reports were prepared by leading organizations that research the market and lobby for the industry-- PWC, CHI and BayBio. They contain useful information for individuals as well as companies in researching the industry here locally. See 2012 report authored by CHI, PWC and BayBio at http://baybio.org/about/2012-biomedical-report/ ******************************************************* NOVA workboard releases a report that is of interest to those looking for new opportunities-- Tech Resumes 2.0, an Employer Perspective Silicon Valley in Transition: Tech Job Growth Poses Both Opportunities and Challenges for the Valley- Based on 250 employer surveys and over 50 executive interviews. As a portion of that effort, NOVA released a 2nd report: “Silicon Valley in Transition: Economic and Workforce Implications in the Age of iPads, Android Apps and the Social Web.” It proposes a number of recommendations for better preparing and connecting job seekers with available employment opportunities and for Silicon Valley to maintain its dominance as the world’s preeminent innovation factory. Tech resumes 2.0, an Employer Perspective - The study includes resume advice from 27 Valley recruiters and hiring decision makers as well as practical employment search and resume tips, key messages for job seekers, employers, economic development leaders, educators, and workforce boards. A link to the report is http://goo.gl/uXTX7 ****************************************************

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Free Newsletters to Keep You Informed Check out free newsletters delivered to your email box: • “Biospace”’s “Genepool,” “Deals and Dollars,” and “Clinical Focus” • “FierceHealthCare,” “FierceHealthIT,” FiercehealthFinancial”, “FierceHealthPayer,” “FierceEMR,” “FierceBiotech,” “FierceMedicalDevices” and “FiercePharma” • “Drug DiscoveryOnline,” • “IN VIVO Blogspot,” “Pharm Exec blog” • “QMed Daily” (formerly DeviceLink.com) • “PRWeek Healthcare Newsletter” • “[email protected] ” ********************************************************************* Ken Wu advises “I found this article titled, 7 Mistakes Job-Seekers Over 50 Make, via the American Society of Quality (ASQ) daily email update. It's worth reading if you're considering how to reposition your self for the upturn in the job market.” The link; http://internsover40.blogspot.com/2009/09/7-mistakes-job-seekers-over-50-make.html?WT.mc_id=EM3965M&WT.dcsvid=1541418993. ************************************************************************* Job Sites Review my weekly listings for individual recruiters and review their websites where they post jobs. The most known site for career and job listings is www.biospace.com which focuses on biotech and pharma. There’s another site which is focused on life science recruitment and placement; note featured company listings may be listed—www.beaker.com There’s website with jobs specific to medical device area at the www.legacymedsearch.com. Darshana Nadkarni posts medtech jobs in the jobs category, in her blog at www.darshanavnadkarni.wordpress.com. For any jobs that interest you, she advises you send resume directly to her at [email protected]. You can look up pharmaceutical jobs in your area by zip code at http://jobs.findpharma.com/careers/jobsearch. They include all functions in pharmaceutical companies. ************************************************************************* Susan Caldwell wrote an article regarding writing a resume as well. “10 Tips for Creating a Door-Opening Resume” by Susan E Caldwell If you're a medical writer, how can you make sure that you still have work in these tough economic times? Important for staff and freelancers alike, marketing your name and abilities can be done in many ways. One way is to develop and maintain a living resume that speaks to the best you have to offer employers. As an experienced worker, you likely have a professional reputation. Maybe it's good, or maybe it's not so good. How can you enhance or improve your resume so that your best shines through? Here are a few suggestions:

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1. Resume Format. Your resume's format should be simple and pleasing to the eye. Because resumes are often input into databases, the simpler the format, the better. Using a simple format should help avoid the need to reformat before your resume is uploaded into a database. When you submit your resume to a recruiter or job board, you should submit it as a Microsoft Word file, but without special formatting. Avoid bullets, bolding, italics, indents, and other formatting that are lost in plain text files. If you do use special formatting, your resume may look like alphabet soup after it's put in a database. Organize your resume in sections, each with a heading that tells the reader what is in that section. Here are some sections typically found in resumes and their approximate order of appearance: Introduction or Career Goal Summary Work History or Professional Accomplishments (if candidate has work history) Academic Background Skills Honors and Awards Publications There are many variations on the organization and section labels listed above, and you should use what is appropriate for your career stage. Points 7-10 (below) specifically address what content should be included in some of your resume's major sections. When you are ready to format your resume, consider looking at the many examples of resumes available online. Seeing the structures of other resumes may help you decide on your own resume's format and organization. 2. Job Targeting. Decide what your target job or assignment is, and tailor your resume to that job. How do you do that? For one thing, you can pepper your resume with the key concepts, terms, and abbreviations for your target job in your resume; this will show that you know the language in that field. Examples include the terms ICH Guidelines, investigator brochure (IB), style guide, and eCTD. Another way to target your resume is to rewrite portions of your resume to match the target job description. This strategy sounds like a lot of work, but it can pay huge dividends. When you submit a targeted resume, it's more likely you will be considered a great match for the position. 3. Resume Emphasis. Emphasize your best accomplishments (for example, an approved eCTD submission that you worked on). Make it clear that you got the job done in an effective way, particularly if it saved time or money. You can do this by positioning these stellar achievements toward the resume's front, writing more about those accomplishments, and/or including specific comments about them in your resume. If there's a web site or information on the web that illustrates or supplements information about your accomplishment, link that information to your resume. 4. Lying on Your Resume. This one is simple: don't lie on your resume. It's a bad idea for several reasons. Not only is it wrong, but if you exaggerate or lie, you may be in over your head if you do get the job. In addition, employers do check resume facts, and they are likely to identify any lies or inconsistencies. 5. Errors in Your Resume. If you're seeking a new job or contract assignment, your resume should be flawless. That is, it should have no typos, misspellings, incorrect grammar, or other writing errors. If you want to open the door to a job interview, show the reader that you are

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careful about your writing. As a medical writer, the writing that appears in your resume will be the first writing sample an employer sees. Be sure that it will stand up to scrutiny. 6. Resume as Living Document. Ensure that your resume is always current and well crafted; it should be a living document. Update it every time you have new material to add to it. Again, the resume's purpose is to get your foot in the door for an interview. If you don't keep your resume current, you may miss a chance to include vital information, especially if you need it on short notice. For this reason, you should always be ready to send your resume to recruiters or employers on a moment's notice. The remaining points in this article address issues within your resume's sections: 7. Summary. At the start of your resume, include a short (usually 1 to 2 paragraphs) thumbnail summary of your work experience and academic background. It's also appropriate to have a statement that tells the reader what your want to do in your next job. 8. Academic Background. The academic background section should include your earned degrees, the name of the institution where you earned the degree, and the dates when they were conferred. If you have earned an advanced degree, this section may be a good place to list the title of your thesis or dissertation, if any. (Alternatively, your dissertation's citation can be included in your resume's Publications section.) A separate section following your academic background can include the continuing education and training courses you've taken. The list should include the subject matter (or course title) and date(s) when you had the training. And here's an important tip: whenever possible, include specific dates for the education and training. The dates add to your credibility, and their absence can be conspicuous. As you advance in your career, your academic background generally becomes less important than your work history. After you have a work history, especially in medical writing, consider moving the academic background information in your resume to a location following your work history. 9. Work History or Professional Achievements. In this section of your resume, include specific details about your work history. The reverse chronological work history format often works well, with your most recent job listed first. The work history section should describe your milestone accomplishments for each job or contract assignment. As with the academic background section, include the start and stop dates for the jobs and/or contract work that you've done. The dates will give you added credibility. 10. Publications. If you've authored any publications, put a list of them in your resume with the full citations in a consistent reference format. For publications with multiple authors, you should include all of the authors' names in the order that they appeared in the publication. Finally, try to get access to electronic copies of your publications on the internet. Consider hyperlinking those citations in your resume to the actual articles. In so doing, your reader can easily find and read examples of your work. You can also prepare a set of publication samples as a zipped file to provide to prospective employers. Done well, your resume will open many doors for you, including some you may want to walk through. There are many resources on the internet that will help you create an excellent resume. Take the time to use them, too! You'll be glad you did.

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About the Author Susan Caldwell is a medical writer, PhD scientist, and entrepreneur. After 10 years of laboratory research, she made a major career course correction and never looked back. She found she could make a career of doing what she loves--writing--and applied it to her background in biomedical research. Since 1995, she has directed medical writers at five life-science companies, including her company, Biotech Ink, LLC. Her specialty is writing regulatory documents for clinical, preclinical, and manufacturing activities that support the development of biotechnology, pharmaceutical, and medical device products. She also has considerable experience writing book chapters, newsletters, brochures, white papers, web content, and many other document types. Susan has been writing and publishing the Biotech Ink Insider newsletter since October 2008. You can email Susan at [email protected], phone her office (650-286-9300), see her LinkedIn profile, follow her on Twitter, and you're invited to join her Medical Writers Twibe (for which you have to have a Twitter account). Copyright 2009 Biotech Ink, LLC. All rights reserved. *************************************************************************Susan E. Caldwell a local medical writer shares some insights into finally mastering touch typing. As writers, we must type to do our work, at least if we're using Microsoft Word or other word processor. Many writers become writers without knowing how to touch type (typing without looking at the keys). Touch typing at 40-60 average words per minute, which is industry standard, is roughly 3 to 4 times faster than you can write by hand. The links below are offered so that you can learn and practice touch typing for free (and they aren't presented in any particular order: 1. http://www.sense-lang.org/typing/ 2. http://play.typeracer.com/ 3. http://10-fast-fingers.com/ 4. http://www.learn2type.com/ 5. http://www.touch-typing-tutor.com/ 6. http://www.nimblefingers.com/ 7. http://www.alfatyping.com/ 8. http://www.typeonline.co.uk/typingspeed.php ************************************************************************* Salary Surveys See most recent life scientist salary survey from The Scientist at http://the-scientist.com/2011/12/01/life-sciences-salary-survey-2011/ Contract Pharma publishes an annual salary survey for employees of contract manufacturing companies at http://www.contractpharma.com/issues/2011-06/view_features/2011-annual-salary-survey/. The most recent Medtech survey for R&D can be found at http://www.mddionline.com/article/salary-survey-2010-research-and-development. You can also find salaries for other functions at the same location. 2011 is now available at http://www.mddionline.com/article/salary-survey-2010-research-and-development MM&M reports salaries in the September issue each year. See 2011 results at http://www.mmm-online.com/25th-annual-career-salary-survey/article/211850/

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************************************************************************* Given the current economic climate, this is a wonderful time to prepare for a career transition and to reassess your career path so that it is aligned with your personal and professional goals. Career Opportunities in Biotechnology and Drug Development, www.careersbiotech.com, published by Cold Spring Harbor Laboratory Press, is a comprehensive, in-depth exploration into the many careers found in the life sciences industry (biotech, pharma and medical devices), based on interviews with over 200 industry executives. It covers 20 vocational areas and over 100 careers. The book was written with the goal of helping readers identify career areas that best suit their interests, values, skills and goals. Each chapter explores the many in-depth nuances of each vocational area. Additionally, there are chapters on resume preparation, job search strategies, informational interviewing and more. A free sample chapter on careers in Project Management is available at www.careersbiotech.com. This insightful and extremely helpful book was researched and written by Toby Beth Freedman, Ph.D., President, Synapsis Search (www.synapsissearch.com) and local guru on life science careers. Toby freely shares her experiences acquired as a researcher, business development manager, recruiter and her indepth research with local industry organizations, such as, local AWIS, the Bio2Device Group and universities. The target audience for this book is people working in academia or in industry who are considering a career transition. It has a broad appeal to scientists, doctors, nurses, lawyers, engineers, business executives, high tech professionals, etc. The book is available on Amazon and a paperback version will be available soon. ************************************************************************* These job postings are listed on my blog accessed at www.audreysnetwork.com along with my suggestions for local industry meetings for networking and expanding your knowledge and skills. Please direct other interested parties to my email address at [email protected] if they wish to receive these mailings directly. *************************************************************************