Patient Safety Senior Medical Director

Role: Lead safety and risk management activities as Senior Medical Director for assigned biopharma products, overseeing all safety-related activities pre- and post-approval. Responsibilities: provide medical evaluation of safety data, lead risk management strategies, contribute to regulatory submissions, represent safety on cross-functional teams, and guide safety reporting and labeling. Engage in departmental SOP development, safety signal detection, and safety communication with affiliates and partners. Qualifications: MD/DO with approximately 7+ years of relevant experience; strong knowledge of GCP, ICH, benefit-risk principles, and safety data evaluation; excellent communication and independent judgment skills. High-Value: focus on safety for biopharma therapeutics, with involvement in clinical trial safety data review, regulatory interactions (e.g., advisory committees), and global safety signal detection. Work setup: hybrid or onsite role, with flexible work arrangements.