Senior Medical Director - Patient Safety

Role: Lead pharmacovigilance for late-stage oncology products, overseeing safety surveillance and regulatory submissions throughout the product lifecycle. Responsibilities: develop and execute safety strategies, analyze aggregate safety data, lead PV document preparation (e.g., risk management plans, periodic safety reports), support NDA/sNDA submissions, and interpret pharmacovigilance regulations. Collaborate with development, clinical, regulatory, and medical affairs teams to guide dose and safety monitoring. Requirements: MD/DO with 2+ years clinical medicine residency, 2-5 years PV/clinical development experience in pharma, oncology patient safety expertise, and experience supporting IND/BLA submissions. Preferred: additional PhD or Clinical Pharmacology fellowship. High-Value: oncology (specific focus on late-stage products), pharmacovigilance, safety data analysis, regulatory document leadership, and cross-functional collaboration. WorkSetup: not specified; position likely based in the US with potential for hybrid or onsite work.