Senior Medical Director- Early Development Oncology

Role: Lead pharmacovigilance for late-stage oncology products, focusing on safety surveillance throughout the product lifecycle. Responsibilities: develop and execute safety monitoring strategies, manage pharmacovigilance documents (e.g., medical safety assessments, risk management plans), analyze aggregate safety data, support regulatory submissions (NDA/sNDA), and guide risk mitigation strategies. Collaborate closely with development medical, PK, toxicology, regulatory, clinical, and medical affairs teams to inform dose selection, trial design, and safety monitoring. Lead safety components in regulatory submissions and responses, and oversee safety reporting (e.g., PSURs, DSURs). Requirements: MD/DO with 2+ years clinical medicine experience, preferably in oncology; 2-5 years pharmacovigilance or clinical development in pharma; strong analytical, writing, and cross-functional leadership skills. Preferred: additional PhD or Clinical Pharmacology fellowship. HighValue: oncology, pharmacovigilance, clinical safety, regulatory submissions, biologics/pharmaceuticals, late-stage development, safety data analysis, global regulatory compliance. WorkSetup: not specified; no travel explicitly mentioned.