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V P , P h a r m a c o v i g i l a n c e Search & Selection

2014

TOGETHER, WE CAN MAKE A DIFFERENCE

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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.

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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

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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

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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 Pharmacovigilence 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!

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Scope of Accountabilities he charter of the Vice President, Pharmacovigilance will be to insure the safety of patients in all

TESARO therapeutic area clinical trials, detecting signals and generating risk management plans regarding drug safety.

s the leader and owner of TESARO’s Pharmacovigilance and Drug Safety program, this individual will provide medical expertise on future safety related initiatives and be accountable for the design and implementation of the safety monitoring plan, ensuring the integrity of all safety and efficacy data. As all TESARO therapeutic programs are in various phases of development, this individual must be alert to all worldwide regulatory authorities’ requirements, i.e., FDA/EMA, and provide key medical guidance to interaction with those authorities, ensuring effective communication both internally and externally, and in both the pre-marketing and post-marketing settings.

eporting to the Chief Medical Officer, this individual will have a leadership role in the company, be a champion of the organization, working to drive the success 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 Pharmacovigilance team;

Drive the development of strategic objectives for the oversight medical surveillance, risk assessment and risk management (RMP, REMS), and provide hands-on tactical design and implementation of appropriate risk mitigation and communication plans;

Ensure patient safety in all clinical studies and post-market surveillance, assessing the safety profile based upon clinical/medical evaluation of adverse reactions, early detection and evaluation of potential safety signals, and primary medical analyses of aggregate safety data;

Provide essential safety expertise for decisions related to study/protocols, regulatory, cross-functional Medical Affairs activities, and internal processes, as well as responding to requests from Regulatory Authorities;

Make key contributions to the preparation of safety sections of IND, NDA/BLA, Annual Reports, Clinical Study Reports and DSURs;

Execute Analysis of Similar Events (AOSE) during data acquisition covering all clinical trials to drive signal detection and risk management activities; generate medical queries upon receipt of Serious Adverse Event aimed at signal detection and risk management

Interact and provide guidance to Regulatory, Clinical, Medical Affairs, Marketing, and Executive Management;

Develop strong partnerships with Regulatory and Clinical functions as part of a strategy to partner with regulatory and health authorities (i.e. FDA) on issues regarding drug safety;

Participate in Independent Data Monitoring Committee activities, audits, inspections, and on cross-functional project teams;

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Build and motivate a team 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;

Contribute and support clinical initiatives through continuous improvement of the quality and safety of all clinical programs 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 Pharmacovigilance & Drug Safety Plan for current pipeline that integrates with current strategic & development goals;

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

Build and manage a process that enables consistent and appropriate safety oversight for patients in clinical trials across the product portfolio with defined triggers for escalation of events and signals;

Build and manage a safety and PV department with appropriate systems and processes that are right-sized for the business strategy and organization given the current state and future projections for growth, with flexibility to morph to the needs of a rapidly changing company while maintaining functionality;

Collaborate with Medical Affairs to build and maintain library of medical information letters that are used to communicate with HCPs in response to inbound inquiries.

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Desired Qualifications he VP, Pharmacovigilance will bring a deep understanding of oncology and possess strong

expertise in the multi-dimensions of the clinical development process, challenges and opportunities.

Professional qualifications will include:

An ABIM (or equivalent) certified physician with US clinical training and/or practice experience is required; Medical specialty and sub-specialty training and certification in oncology is strongly preferred;

Minimum of 12 years pharmaceutical industry safety experience , i.e. drug safety filing procedures and a working knowledge of domestic and international regulatory requirements;

5+ years of hands on experience in both pre and post-marketing settings required;

Deep understanding of underlying medical issues faced by patients with cancer, and perspective when making judgment calls/recommendations about a potential safety issue;

Thorough understanding of the regulatory environment for safety and Pharmacovigilance with working knowledge of worldwide regulatory guidelines, including FDA , EMA and ICH;

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.

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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 tfuller@EpsenFuller.com

+1 212-392-4842

Rick Cannellos Life Science Partner

rcannellos@EpsenFuller.com +1 646-706-7602

Elisabeth Parkinson Director, Life Science Research eparkinson@EpsenFuller.com

+1 443-996-8663

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