Senior Global Development Scientist, Director

Role: Lead clinical science for late-phase oncology trials, translating strategy into protocols and guiding global pivotal studies from concept to registration. Responsibilities: develop study concepts, ensure protocol integrity, oversee trial delivery, safety monitoring, data review, regulatory submissions, and external engagement; serve as a cross-functional leader and mentor within the clinical development team. Requirements: PharmD, Ph.D., or MD; 7+ years in drug development with significant oncology expertise; strong knowledge of FDA/regulatory standards, GCP, and clinical operations; proven ability to lead complex global trials and collaborate across functions. HighValue: oncology, late-phase (Ph 2/3), biomarker and adaptive trial methodologies, regulatory submissions (NDA/BLA), global clinical execution. WorkSetup: in-office (Gaithersburg, MD or Cambridge, MA) with flexibility, some travel expected.