Sr. Director - Clinical Trials, Clinical Development
Foundation Medicine · Boston, Massachusetts, United States
About this role
About the Job: The Sr Director, Clinical Trials, Clinical Development is a senior, highly visible and cross-functional leadership role within the Foundation Medicine (FMI) Clinical Development team, partnering closely with various teams across the company. It is designed for a biopharma drug developer leader with deep experience across first-in-human (FIH) through Phase 3 clinical trials. This position partners with internal and external collaborators to design, execute, and interpret precision medicine-enabled clinical trials that integrate FMI’s genomic profiling into therapeutics development programs
The ideal candidate is an experienced physician (M.D.) with a strong track record in oncology drug development, clinical protocol authorship, and end‑to‑end execution of global interventional studies. This leader will ensure that FMI assays are optimally incorporated into internal evidence programs defined in the Clinical Development Plans (CDPs), and into biopharma or academic (AMC)-sponsored trials in order to generate data that support clinical development, regulatory and reimbursement strategy, and downstream clinical adoption. Key Responsibilities: • Provide strategic and scientific leadership for clinical trial design and execution across FIH, Phase 1, Phase 2, and Phase 3 oncology programs incorporating precision medicine approaches to support CDPs and product strategy
• Lead or co-lead the design, authoring and review of clinical protocols, including biomarker strategies, statistical consideration and operational feasibility. • Serve as a senior clinical development partner to biopharma or AMC collaborators, advising on optimal use of FMI assays within therapeutic development programs. • If appropriate, oversee execution of interventional and observational studies, ensuring high-quality delivery, data integrity, and adherence to GCP and regulatory standards • Provide expert clinical input into the translational research to develop insights into predictive a
Apply for this role on Foundation Medicine’s official careers site.