Senior Medical Director, Global Drug Safety

Role: Senior Medical Director, GDS&RM, specializing in pharmacovigilance and safety signal management for Replimune’s oncolytic immunotherapies. Objectives: oversee safety monitoring, benefit-risk assessments, and regulatory safety submissions to ensure product safety and compliance. Responsibilities: lead safety signal detection and management activities, oversee safety data review including ICSRs and aggregate reports, collaborate cross-functionally with Clinical Development, Medical Affairs, Regulatory, and Data Management; support regulatory filings and safety communications; direct safety-related audits and inspections; develop pharmacovigilance strategies and maintain regulatory knowledge. Requirements: MD or equivalent, minimum 8 years’ experience in safety/pharmacovigilance within biopharma, with at least 4 years clinical practice in academic or hospital settings. Expertise in oncology, immunotherapy, and biologics (viral vectors preferred). Knowledge of GCP, ICH, FDA, EMA regulations; proficiency with drug safety software (e.g., ARIS-G, ARGUS); strong communication, organizational, and problem-solving skills. Work setup: hybrid in Woburn, MA, requiring a minimum of 2 days onsite weekly. High-value: oncology, immunotherapy, viral vectors, biologics, pharmacovigilance, safety signal detection, regulatory compliance, clinical safety, and global safety standards.