Patient Safety Medical Director

Role: Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH), overseeing safety and benefit-risk activities for Vertex's products from first-in-human trials through post-marketing. Responsibilities: lead safety teams, manage signal detection, develop and implement risk management strategies, collaborate on regulatory submissions (e.g., labeling, RMPs, REMS), review safety data and reports, and support safety-related regulatory responses. Work closely with Clinical, Medical Affairs, and Regulatory teams to ensure safety compliance and proactive risk assessment. Requirements: MD, with 7+ years in pharmacovigilance or safety, including management experience; broad medical knowledge, expertise in GxP, ICH, and global regulations; strong leadership and communication skills. HighValue: focus on biopharma safety across early and late clinical stages, including post-marketing; experience with benefit-risk evaluation, signal detection, regulatory submissions, and safety data review; hybrid or onsite; flexible work arrangements.