Director, Global Patient Safety Sciences Delivery - General Medicine

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.,

• The Director is responsible for the development of their team, which is comprised of Safety Scientists. The Director will also be expected to work closely with other Directors on driving standardization and consistency in execution of signal detection activities in partnership. This role will 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 TAs
• 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 in 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 support Safety Sciences Strategy in contributing 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 Strategy and Delivery
• Serve as main point of contact to liaise with Safety Sciences Strategy General Medicine GPS Leads
• Collaborate with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management)
• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
• Implement talent strategy and leadership development initiatives that raise capabilities across the organization
  
  Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and General Medicine experience
• Strong attention to detail with the ability to assess and optimize Safety operations processes, drive consistency, and ensure high-quality, compliant execution across activities
• Strong leadership capabilities and presence, interpersonal, verbal and written communication skills organizational and workload planning skills along with the ability to manage multiple different projects simultaneously
• Preferred experience with oversight of operations within a global patient safety organization
• Preferred experience with AI technologies
• Preferred experience leading a matrixed role working across multiple areas of an organization and people management experience
  
  Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the
recruitment process. If you have any questions, please speak with your recruiter.