Vice President Late Stage Development

Clinical Affairs Bothell, Washington


Description

Summary: 

Reporting to the SVP of Late Stage Development, this position will lead the development of Enfortumab Vedotin and have overall accountability for the program.  This position will be responsible for defining and delivering a comprehensive development strategy while partnering with cross-functional stakeholders to ensure effective and efficient execution of the program.  This position will also lead the Global Development Team (GDT), represent Development on the Global Product Team (GPT), and serve as the primary representative of the product at governance meetings.  For partnered programs, this position will be responsible for working closely with partners to align and execute on a joint development strategy. 

 

Serving as the primary representative of the product at governance meetings, and as the scientific and medical expert internally and externally, this position will also represent the product strategy, plans, objectives, and interests to health authorities (HAs) and prominent thought leaders worldwide.

 

Responsibilities:

  • Overall strategic lead and accountable for delivering on the program strategy.  Represent the Development strategy on the Global Product Team (GPT) to develop and execute an integrated cross-functional global product strategy working in partnership with GPT members (Regulatory, Safety, Medical Affairs, CMC, Value & Access, Commercial and Program Team Leadership & Management) and key contributors (Biostatistics, Translational Sciences)
  • Lead the Global Development team accountable for developing and executing the development strategy of a late stage program.  The GDL will design and guide strategy from proof of concept through initial approval and subsequent development
  • Accountable for the design, execution and medical/scientific data interpretation of global clinical studies, and provides advice and guidance on other evidence generation programs
  • Oversee the diagnostic and biomarker plans for the program
  • Oversee the clinical pharmacology plans to support registration
  • Provide clinical leadership for global regulatory submissions
  • Accountable for the evaluation and interpretation of safety, pharmacology, and efficacy data from ongoing and completed studies
  • Oversee strategy and execution of preparation of manuscripts, abstracts and presentations for scientific meetings and Development advisory boards
  • Collaborate with a variety of internal and external partners and stakeholders, such as HAs, clinical investigators, clinicians, scientists and key opinion leaders (KOLs)
  • Provide leadership and management to clinical personnel and medical monitors who support the clinical study teams
  • Medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
  • Responsible for direct line management of multiple medical directors, with oversight of other staff in the matrix environment

 

Qualifications:
 

  • MD (or non-US equivalent) or MD/PhD with board certification in medical oncology and/or hematology preferred
  • 7+ years of experience in the pharmaceutical/biotech industry experience in oncology drug development preferred
  • Demonstrated experience working on late stage product development, including global regulatory filings and experience with product launches and life cycle management is preferred
  • Demonstrates strategic agility: has in-depth knowledge and broad experience in the pharma/biotech industry and is able to bring this to bear in accomplishing strategic goals and objectives
  • Has a strong leadership presence and the ability to work effectively with other clinical/scientific and cross functional leaders
  • Demonstrated expertise in study design, protocol generation and data analysis
  • Outstanding interpersonal skills; proven track record of building strong and sustainable relationships with internal & external partners/stakeholders
  • Strong staff management and mentoring experience and skills
  • Excellent communicator (written and verbal); exhibits professional maturity, and strong presentation skills (confident and competent presenting to Executive Committees and Board of Directors)
  • Team player, works well in a team environment both as a leader and a key contributor
  • Global perspective and mindset with ability to work effectively with colleagues from varied cultures, backgrounds and geographies


As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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