Patient Safety Senior Medical Director

Vertex Pharmaceuticals seeks a Patient Safety Senior Medical Director to lead safety and risk management activities for assigned pharmaceutical products across pre- and post-approval stages. The role requires medical expertise in clinical safety evaluation, regulatory submissions, and cross-functional team leadership in Boston.

Responsibilities

• Lead safety representation on cross-functional clinical teams and programs for assigned products.
• Conduct medical evaluation of safety data from toxicology, non-clinical studies, and product quality complaints.
• Provide strategic leadership on periodic safety reports, risk management deliverables, and product labeling.
• Review individual case safety reports from clinical trials and post-marketing sources with timely medical judgment.
• Participate in protocol development, safety data analysis, and regulatory submissions including Advisory Committee meetings.

Requirements

• MD, DO, or equivalent non-US medical degree
• 7+ years of relevant experience or equivalent education and experience combination
• Advanced knowledge of General Medicine and benefit-risk assessment principles
• Solid understanding of GCP, ICH guidelines, and global regulatory requirements
• Advanced experience evaluating safety data, adverse events, and clinical study documents
• Strong written and oral communication skills for complex topics and senior stakeholder engagement
• Sound independent judgment and decision-making in matrix environments

Compensation: $276,000 - $414,000 base