Medical Director, Global Drug Safety

Role: Medical Director, GDS&RM, overseeing safety assessments for Replimune’s oncology therapies, both pre- and post-approval. Responsibilities include conducting safety case reviews, leading safety signaling activities, representing the department in audits, and contributing to clinical and regulatory safety documentation. The role involves close collaboration with clinical teams, Medical Affairs, and regulatory groups to monitor, evaluate, and report safety data, including SAE reconciliation, benefit-risk assessments, and regulatory submissions. Qualifications: MD, DO, or equivalent; minimum 5 years in drug safety/pharmacovigilance or medical monitoring, with oncology/immunotherapy experience preferred. Skills include strong medical knowledge, understanding of GCP/ICH, safety data analysis, and regulatory report generation. High-Value: focus on oncology (cancer immunotherapies), safety monitoring during clinical trials and post-marketing, experience with NDA/BLA submissions, and familiarity with global safety regulations. Work setup: hybrid in Woburn, MA, requiring a minimum of 2 days/week onsite.