Senior Medical Director - Patient Safety

Role: Lead pharmacovigilance for late-stage oncology products, overseeing safety surveillance, signal detection, risk management, and regulatory submissions throughout the product lifecycle. Responsibilities: develop safety strategies, interpret safety data, author core PV documents (e.g., PSURs, RMPs), support IND/BLA submissions, and guide safety aspects of first-in-human trials and NDA processes; collaborate with medical, regulatory, PK, and toxicology teams. Requirements: MD/DO with 2+ years in internal medicine residency; 2-5 years pharma PV/clinical development experience focusing on oncology; experience with regulatory submissions (IND/BLA); strong analytical, communication, and cross-functional leadership skills. Preferred: PhD or Clinical Pharmacology fellowship; oncology patient safety expertise. High-Value: oncology, late-phase, pharmacovigilance, regulatory submissions, risk management, cross-functional collaboration. WorkSetup: not specified; no travel indicated.