Director, Global Patient Safety Sciences Delivery - Rare Disease

Role: Director of Global Patient Safety Sciences Delivery for Rare Disease at Regeneron, overseeing safety data processing, signal management, and regulatory reporting to ensure high-quality, compliant safety surveillance. Responsibilities include developing standardized processes for signal detection, managing safety monitoring activities, analyzing safety data for emerging issues, and supporting benefit-risk assessments across the portfolio. The role involves leading a team of Safety Scientists, fostering cross-functional collaboration, and driving continuous improvement through innovative approaches and technology integration. The position requires building training programs and serving as the primary liaison with Safety Sciences Strategy and other departments.

Qualifications: Advanced degree in life sciences or healthcare; 12+ years of pharmacovigilance experience, with a focus on safety sciences and rare diseases preferred. Strong leadership, organizational, and communication skills are essential, along with experience managing global safety operations and working within matrixed teams. Preferred skills include familiarity with AI technologies and experience in people management.

High-Value Details: Focus on rare disease safety surveillance within a global PV structure; work involves signal detection, aggregate safety reporting (e.g., DSURs, PSURs), and contributing to regulatory documents (ARM, RMP, SMP). The role is based in Tarrytown, NY, requiring 4 days onsite and approximately 25% travel. The scope emphasizes compliance with GxP and regulatory standards, with a strategic focus on safety data analysis and process standardization.