Senior Director, Global Patient Safety Science

Rapport Therapeutics seeks a Senior Director of Global Patient Safety Science to lead safety strategy and pharmacovigilance across clinical development programs. This role requires expertise in signal detection, risk management, and regulatory submissions for precision neuromedicines in development.

Responsibilities

• Develop and operationalize safety surveillance strategy and signal detection protocols
• Lead risk management activities including protocol safety sections, reference safety information, and labeling
• Oversee preparation of DSURs, safety components of study reports, and regulatory submissions
• Participate in Data Monitoring Committees and guide safety data interpretation
• Advance signal management capabilities through technology adoption and team mentorship

Requirements

• Extensive experience in pharmacovigilance and clinical safety surveillance
• Demonstrated expertise in signal detection and risk management strategy
• Strong knowledge of regulatory submissions and compliance (IND, NDA, MAA)
• Experience leading Data Monitoring Committees and safety governance
• Scientific acumen in evaluating clinical trial safety data and real-world evidence
• Track record implementing digital tools and process improvement in safety operations