Director, Global Patient Safety Sciences - Oncology

Regeneron seeks a Director of Global Patient Safety Sciences for oncology compounds. This leadership role oversees all safety surveillance, signal management, and regulatory strategy for assigned assets across development and commercialization. The position requires deep pharmacovigilance expertise and the ability to lead cross-functional teams in a matrix environment.

Responsibilities

• Lead safety strategy and serve as primary contact for all safety issues across assigned compounds
• Oversee signal management, benefit-risk assessment, and safety surveillance activities
• Chair and lead Safety Monitoring Team and represent GPS on cross-functional strategic teams
• Develop and maintain safety documents (DSURs, PSURs, development and commercial RMPs)
• Mentor junior safety scientists and drive continuous improvement initiatives within the organization

Requirements

• 10+ years in pharmacovigilance, medical field, or clinical drug safety (with PSUV/DSUR/RMP experience)
• Alternative: 5+ years relevant experience with PharmD, PhD, or MD degree
• Demonstrated expertise in safety document preparation and regulatory submissions
• Strong knowledge of FDA, EU, and ICH pharmacovigilance guidelines and regulations
• Proven leadership experience managing diverse safety science teams
• Oncology clinical or industry experience preferred