Director, Safety Scientist Lead - General Medicine

About the role

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director to join our Global Patient Safety Sciences Delivery team. The Director, Global Patient Safety Sciences Delivery, General Medicine, serves as the first point of contact for all General Medicine operations including safety data processing, submission creation, and documentation to ensure completeness, accuracy, and timeliness. This role is responsible for high quality, compliant execution of safety surveillance, signal management, and aggregate reporting activities across the portfolio. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

• Develop the team of Safety Scientists and work closely with other Directors to drive standardization and consistency in execution of signal detection activities.
• Report to the ED, Global Patient Safety Sciences Delivery.
• Develop common practices, processes and templates to drive standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and therapeutic areas.
• Ensure compliance and quality management of Safety Sciences Delivery activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools.
• Lead all aspects of signal detection coordination and signal management process across General Medicine, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER).
• Develop innovative approaches to delivering on core activities that integrate new technologies; analyze aggregate safety data to identify emerging safety issues and patterns, in partnership with Safety Sciences Strategy.
• Support cross‑functional coordination to support high quality, timely, and compliant delivery of benefit‑risk assessment for periodic safety reports (e.g., DSURs, PSURs) and contribute Medical and Safety perspective to the GPS portfolio of documents (e.g., ARM, RMP, SMP) where required.
• Drive development and implementation of relevant training programs for GPS staff, including maintenance of a standardized Safety Sciences training curriculum, proficiency matrix, and knowledge management repository across both