Director, Safety Scientist Lead - Rare Disease

Regeneron Pharmaceuticals • Warren, MA

3d • Onsite

About The Position

Regeneron is seeking a Director to join its Global Patient Safety Sciences Delivery team. The Director, Global Patient Safety Sciences Delivery, Rare Disease, serves as the first point of contact for Rare Disease operations, including safety data processing, submission creation, and documentation, ensuring completeness, accuracy, and timeliness. The role is responsible for high-quality, compliant execution of safety surveillance, signal management, and aggregate reporting across the portfolio.

The Director develops and leads a team of Safety Scientists and partners with other Directors to standardize and ensure consistency in signal detection and related activities. The position reports to the Executive Director, Global Patient Safety Sciences Delivery, and works closely with Safety Sciences Strategy and cross-functional partners across the organization. The role is based in Tarrytown, New York, with four days per week on site; travel may be required, estimated at 25%.

Requirements

• Advanced degree in life sciences or healthcare.
• 12 or more years of pharmacovigilance experience.
• Strong attention to detail and ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution.
• Strong leadership capabilities and presence.
• Strong interpersonal, verbal, and written communication skills.
• Organizational and workload-planning skills, including the ability to manage multiple projects simultaneously.

Nice To Haves

• Pharmacovigilance experience focused on Safety Sciences and experience in Rare Disease.
• Experience overseeing operations within a global patient safety organization.
• Experience with AI technologies.
• Experience leading a matrixed role across multiple areas of an organization.
• People management experience.

Responsibilities

• Develop common practices, processes, and templates to standardize core activities, including signal detection and authoring sections of safety documents, across products and therapeutic areas.
• Ensure compliance and quality management of Safety Sciences Delivery activities, including regulatory compliance and the establishment of SOPs and monitoring tools.
• Lead signal detection coordination and signal management across Rare Disease, including Safety Monitoring Teams, Safety Surveillance Plans, and Signal Evaluation Reports.
• Develop innovative approaches to core activities that integrate new technologies.
• Analyze aggregate safety data to identify emerging safety issues and patterns in partnership with Safety Sciences Strategy.
• Coordinate cross-functional work to support high-quality, timely, compliant benefit-risk assessments for periodic safety reports such as DSURs and PSURs.
• Support Safety Sciences Strategy in contributing medical and safety perspectives to Global Patient Safety portfolio documents, including ARM, RMP, and SMP, as required.
• Drive development and implementation of training programs for Global Patient Safety staff, including a standardized Safety Sciences training curriculum, proficiency matrix, and knowledge management repository across Strategy and Delivery.
• Serve as the main point of contact for liaison with Safety Sciences Strategy Rare Disease GPS Leads.
• Collaborate with key Regeneron interfaces, including Clinical, Regulatory, Medical Affairs, Biostatistics, and Data Management.
• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines.
• Implement talent strategy and leadership development initiatives to raise capabilities across the organization.

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match, depending on country and role.
• Health and wellness programs, depending on country and role.
• Fitness centers, depending on country and role.
• Insurance benefits, including medical, dental, vision, life, and disability insurance, depending on country and role.
• Paid time off, depending on country and role.
• Family support benefits, depending on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Director