Reporting to the Clinical Development Lead, Biotech Unit (BU), the position is a member of BU and contributes to clinical development strategy and supports successful execution of clinical development programs in BU.
Leveraging deep therapeutic and functional area expertise, the incumbent will play a key role in medical monitoring for pivotal stage studies, will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research to ensure successful deliveries by study team.
**Essential Functions of the Job:**
+ Facilitate generation of, author, update, and/or review key documents, including, but not limited to:
+ Protocol concepts, synopses, protocols, and amendments of Informed con...