tesaro vp of medical development search & selection

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World Wide Search | World Class Leaders US Partner of IMD International Search VP, Medical Development Search & Selection 2014 TOGETHER, WE CAN MAKE A DIFFERENCE

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Epsen Fuller Group announces a new search for a Vice President, Medical/Clinical Development.

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Page 1: TESARO VP of Medical Development Search & Selection

World Wide Search | World Class Leaders

US Partner of IMD International Search

V P , M e d i c a l D e v e l o p m e n t Search & Selection

2014

TOGETHER, WE CAN MAKE A DIFFERENCE

Page 2: TESARO VP of Medical Development Search & Selection

US Partner of IMD International Search

Founded in 2010, TESARO is a

publicly-held, oncology-focused

biopharmaceutical company

dedicated to improving the lives of

cancer patients by leveraging the

experience and competencies of its

leadership team to acquire, develop

and commercialize safer and more

effective therapies for the treatment

and support of patients with cancer.

Page 3: TESARO VP of Medical Development Search & Selection

World Wide Search | World Class Leaders

US Partner of IMD International Search

ESARO has achieved numerous milestones since its founding in 2010 and is, after successful Phase III trials, on the threshold of submitting an NDA in mid-2014 for rolapitant, a potent and selective neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).

nrollment is ongoing in two Phase 3 trials of niraparib, a potentially best in class, orally active PARP inhibitor, in ovarian cancer maintenance and BRCA-positive breast cancer. Together, these initial two market opportunities are estimated to exceed $3B worldwide.

dditionally, TESARO recently announced the expansion of the niraparib development program to include further trials in small cell lung cancer and first line ovarian cancer maintenance.

ost recently, TESARO announced an exclusive worldwide license agreement with AnaptysBio for multiple immuno-oncology programs, which provides a portfolio of candidates focused on high value targets, potentially augments the value of other pipeline candidates, and enhances TESARO's overall oncology strategy. The therapeutic antibodies selected from these programs will form the basis of a strategic platform that will enable TESARO to develop novel monotherapy and combination-based approaches with immuno-oncology and other anti-cancer agents in a variety of indications.

Near-Term Milestones: Nearing NDA submission of rolapitant for the prevention of CINV; Continuing PH III clinical development and successfully commercialize

niraparib for cancers that are susceptible to PARP inhibition; Advancing TSR-011 through clinical trials for treatment of NSCLC and other

tumor types associated with ALK and TRK mutations; Potential first-in-class anti-TIM-3 antibody clinical candidate expected to be

selected second-quarter 2014; Anti-LAG-3 antibody clinical candidate expected to be selected by third-

quarter 2014; Dual reactive antibody clinical candidates targeting PD-1/TIM-3 and PD-

1/LAG-3 expected to be selected by first-quarter 2015; Investigation planned - preclinical combinations of TSR-042 (anti-PD-1

antibody) with each of TSR-011 (ALK/TRK inhibitor) and niraparib (PARP inhibitor);

First clinical trial of TSR-042 projected to begin in H2 2015.

See TESARO’s ASCO 2014 Presentation

Page 4: TESARO VP of Medical Development Search & Selection

US Partner of IMD International Search

Executing on the Mission of Improving the Lives of Patients with Cancer

Phase 3 Trials of Rolapitant Initiated

2010 2011 2012 2013 2014

TSR-011 IND Cleared

TSR-011 Phase 1 Trial

Initiated

Niraparib In-Licensed

Initial Phase 1 TSR-011 Data

Presented

Niraparib Phase 3 Trial in Ovarian Cancer Initiated

Rolapitant IV Clinical Program

Initiated

First Two Pivotal Trials of Rolapitant Successfully

Completed

IO Platform

In-Licensed

Third Pivotal Trial of Rolapitant Successfully

Completed

Niraparib Phase 3 Trial in Breast Cancer Initiated

Market Cap - $1 Billion

Rolapitant In-Licensed

TSR-011 In-Licensed

Series B Financing - $101M IPO - $87M

Follow-on Stock Offering -

$98M

TESARO Founded; Series A Financing -

$20M

Follow-on Stock Offering -

$101M

Page 5: TESARO VP of Medical Development Search & Selection

World Wide Search | World Class Leaders

US Partner of IMD International Search

Opportunity

ESARO is undergoing a full-scale expansion in preparation of product commercialization post-FDA approvals, and to support the expansion of their exciting immuno-oncology platform.

o-Founders, Lonnie Moulder, CEO, and Mary Lynne Hedley, Ph.D., President & CSO, are building a world-class team dedicated to improving the lives of patients with cancer and leveraging their collective knowledge and experience to transform TESARO into an integrated development and commercial stage company. With a current market capitalization of ~$1Billion, and a successful track record in fund-raising, the company is well-positioned to capitalize on its impressive and balanced portfolio of products under development.

ith this foundation, impressive history of accomplishments and trajectory in just four years since inception, a seasoned management team, and strong and growing pipeline of oncology and immuno-oncology candidates, TESARO is executing on its mission to successfully commercialize multiple products globally, and fulfill its vision of re-defining cancer treatment, including immuno-oncology as a platform that will become the foundation of many future cancer therapy regimens.

his rapid growth demands that TESARO expand their management team and are seeking a Vice President of Medical Development to report to the Chief Medical Officer, Robert Martell, M.D., Ph.D.

his is a unique opportunity to join an exciting biotech company that 1) is well-funded to pursue a very robust pipeline of candidates under various stages of development; 2) is led by a senior leadership team that is highly regarded among the investor community; 3) maintains a collegial and family-style culture while operating in an intense, high-pressure/high-impact environment; and 4) has the true promise of bringing to reality safer and more effective therapeutics and changing the lives of patients with cancer.

Meet the TESARO Co-Founders!

Page 6: TESARO VP of Medical Development Search & Selection

US Partner of IMD International Search

Scope of Accountabilities eporting directly to the Chief Medical Officer, the new Vice President of Medical Development will

have complete oversight of all clinical development teams with direct reports including five Medical Directors. As an integral member of the senior leadership team, this individual will provide the highest level of clinical knowledge and strategic direction with complete accountability for the Medical Development function to ensure TESARO’s continued success in their strategic therapeutic areas through innovative clinical design and outstanding scientific leadership.

he/he will have a significant positive impact on the overall clinical effectiveness by proactively defining, leading and implementing the medical development strategy associated with all development programs up through registration. She/he will collaborate with key internal stakeholders across multifunctional groups including regulatory, stats, medical writing, clinical operations and medical affairs as well as external stakeholders including CROs and KOL’s.

ith an emphasis on being a champion of the organization, s/he will be a visible and outward facing leader working to raise awareness of TESARO’s portfolio of promising novel oncology and supportive care product candidates.

Specific Accountabilities include:

Create a compelling and inspired vision and sense of core purpose that is sharable by everyone on the Clinical Development team;

Build and motivate a team of multidisciplinary professionals and clinical scientists through a time of rapid change and growth; drive a positive organizational culture, and provide ongoing coaching, guidance and feedback to ensure functional excellence and success;

Drive the development of innovative medical strategies, ensuring that the overall scientific and medical content of all clinical programs is sound, and provide hands-on oversight of the tactical implementation of all clinical projects;

Ensure the integration of pre-clinical and early clinical findings with planned clinical programs; secure cross functional alignment and/or transparent discussion of risks associated with clear plans to further investigate and track through clinical development;

Prepare clinical development plans, and institute properly approved clinical protocols;

Design scientifically rigorous and maximally cost-effective clinical development programs for the desired indication(s); present and defend protocols;

Monitor study progress, leading the analyses and data evaluation process for progress reporting and presentations;

Prepare various official and regulatory documents for Regulatory and other agencies and effectively address medical issues/questions on study for regulatory authorities/IRBs;

Page 7: TESARO VP of Medical Development Search & Selection

World Wide Search | World Class Leaders

US Partner of IMD International Search

Drive safety signal detection monitoring of clinical trials, and manage the process from protocol development thorough individual study report and integrated regulatory documentation;

Ensure that Serious Adverse Events are properly reported;

Contribute and support clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver TESARO’s expanding portfolio;

Be an outward champion of the organization and its mission, expanding TESARO’s influence throughout the industry, strengthening its reputation for excellence in innovative science and practical therapies for the treatment of cancer.

Key Year One Objectives Gain understanding of current programs, key assumptions,

deliverables, internal and external risks and deliver a fully-vetted Clinical Development Plan for current pipeline that integrates with current strategic & development goals;

Establish a Vision related to Medical Development, and foster organizational buy-in; conduct a gap analysis related to that vision, implement necessary changes, and hire key staff;

Define and implement a code of work practice for collaborating with each functional area within the company, with endorsement by the head of each functional area;

Define immuno-oncology clinical development strategy, and deliver effective in-house education and training to ensure both organizational buy-in and effective implementation;

Identify and establish forward looking immuno-oncology KOL relationships, Clinical Advisory Boards, and associated total medical budget.

Page 8: TESARO VP of Medical Development Search & Selection

US Partner of IMD International Search

Desired Qualifications he VP, Medical Development will bring a deep understanding of immunology, oncology and

emerging immuno-oncology platforms, and have a strong expertise in the multi-dimensions of the clinical development process, challenges and opportunities.

Professional qualifications will include:

An ABIM (or equivalent) certified medical oncologist with US clinical training and/or practice experience is required; Specialty training in immunology, and/or immuno-oncology is strongly preferred;

Substantial clinical development experience in immuno-oncology is required;

12+ years experience in the Pharmaceutical, Biopharma, or Biotechnology industry, to include several years as a clinical development leader of oncology and immunology products that realized demonstrated success;

Significant understanding of the challenges and issues associated with delivering multiple effective, successful clinical development programs;

Experience in the development of drug candidates from research through preclinical development and a proven record for advancing drug candidates through the clinic; knowledge of FDA, EMEA, and ICH guidelines governing clinical development;

Deep knowledge of leading KOL’s worldwide in the area of immunology, oncology and combination therapies and related technologies;

Superior conceptual and critical thinking skills, naturally innovative, and ability to integrate disparate input with demonstrated intellectual rigor is an absolute must;

Ability to structure, manage, and coordinate complex cross-enterprise projects, analyses and processes with multiple work streams and multiple stakeholders at both senior and junior levels;

An excellent and persuasive communicator with strong oral and flawless written communication skills.

Personal characteristics and attributes will include:

Particularly energetic, responding with quick a sense of urgency; an outcome-focused individual who sets genuinely ambitious, challenging goals, in a results-oriented organization;

Interpersonal skills to include a sense of humility, tactful diplomacy, and ability to influence; the gravitas, self-awareness and leadership to operate at the highest intellectual and strategic levels;

Ability to operate effectively in environments with rapid change, complexity and uncertainty;

A team-player with a collaborative approach and a natural desire to achieve consensus; a strong relationship builder;

A value system that includes flawless personal and business honesty, integrity, openness, and a dedication to exceeding expectations.

Page 9: TESARO VP of Medical Development Search & Selection

World Wide Search | World Class Leaders

US Partner of IMD International Search

Location The position is based in the Boston, MA area and will include moderate travel.

Compensation The successful candidate will receive a competitive and compelling compensation package, which will include an attractive base salary, performance based bonus, equity participation, and long-term incentives.

Application Process Candidates who represent the opportunities and attributes presented in this profile are encouraged to contact Epsen Fuller Group. All inquires are kept strictly confidential and may be made to: Equal Employment Opportunity Epsen Fuller Group shall provide equal employment opportunity to all qualified candidates, and will refer candidates without regard to race, color, religion, national origin, sex, age, disability, veteran status or any other legally protected basis. Epsen Fuller Group shall comply with all applicable laws, rules and regulations in the performance of duties pursuant to this project, including but not limited to, Title VII of the Civil Rights Act, the Age Discrimination in Employment Act, the Americans with Disabilities Act, and state and local anti-discrimination laws to the extent applicable.

Thomas Fuller CEO & Managing Partner [email protected]

+1 212-392-4842

Rick Cannellos Life Science Partner

[email protected] +1 646-706-7602

Elisabeth Parkinson Director, Life Science Research [email protected]

+1 443-996-8663

Page 10: TESARO VP of Medical Development Search & Selection

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