Director, Global Patient Safety Sciences Delivery - Rare Disease

Regeneron Pharmaceuticals•Warren, MI

8d•Hybrid

About The Position

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, 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.

Requirements

Advanced Degree required in life sciences or healthcare
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

Nice To Haves

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

Responsibilities

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.
Responsible for high quality, compliant execution of safety surveillance, signal management, and aggregate reporting activities across the portfolio.
Responsible for the development of their team, which is comprised of Safety Scientists.
Work closely with other Directors on driving standardization and consistency in execution of signal detection activities in partnership.
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.