Clinical Development Director

5 days ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Director, Clinical Development

Job Summary:

As a key member of our clinical development team, the Director, Clinical Development will serve as a primary source of medical accountability and oversight for one or more clinical trials. This role will be responsible for matrix management responsibilities across the internal and external network, managing Phase 1-3 studies, and providing medical and scientific expertise to cross-functional DSI colleagues.

Responsibilities:
  • Provide medical input regarding country feasibility and contribute to site feasibility assessments from a physician's perspective.
  • Participate in the design of eCRFs, UAT, and CCG reviews, and conduct clinical data reviews per Integrated Data Review Plan (IDRP).
  • Assess protocol deviations, discuss medical eligibility questions, and answer safety questions related to dose modifications, discontinuations, and adverse event management.
  • Participate in Site Initiation Visits (SIV) and conduct medical monitoring visits to provide medical input.
  • Provide medical guidance for coding of AEs, medical history, and medications when needed.
  • Address medical questions directly from sites/IRBs and other site personnel as needed.
  • Serve as a study-specific subject matter expert (SME) for internal audit or Health Authority (HA) questions related to medical monitoring.
Qualifications:
  • MD or equivalent required.
  • Postgraduate training in a therapeutic area (TA) or related specialty preferred.
  • 4 or more years of industrial experience required.

Travel: Ability to travel up to 20% domestically and internationally.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.



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