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About the Role

The Director, Global Patient Safety Sciences Delivery, Rare Disease, serves as the first point of contact for all Rare Disease 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 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 Rare Disease, 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 Rare Disease 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

Requirements

• Advanced Degree required in life sciences or healthcare with 12+ years of PV experience, preferably with a focus on Safety Sciences and Rare Disease 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

Location

• Uxbridge, UK

Work Type

• 3 days per week on site
• 25% Travel may be required

Experience Level

• 12+ years of PV experience

Education Level

• Advanced Degree in life sciences or healthcare

Benefits

• 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
• family support benefits

About the Company

• At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

Equal Opportunity

• Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
• Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.