Executive Director, Global Patient Safety Sciences Delivery

Executive Director, Global Patient Safety Sciences Delivery

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Executive Director to join our Patient Safety team.

The Executive Director, Global Patient Safety Sciences Delivery serves as the key point of contact for all Safety Sciences operations and risk-related responsibilities across all Therapeutic Areas (TAs). This role is responsible for driving consistency across the portfolio for standard activities performed by the Safety Scientists (e.g., data transformation, safety surveillance, SMT preparation, early draft of aggregate reports, signal evaluations, label enhancement justifications). This role is also responsible for the processes and written procedures that underpin the safety governance, and other fundamental processes within Safety Sciences. This role requires the ability to work cross-functionally, partnering with the Safety Sciences TAHs and other leaders. They will serve as a member of the GPS Leadership Team (GPS LT). The Executive Director, Global Patient Safety Sciences Delivery is also responsible for the development and management of their team.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Work Location: Tarrytown, NY, Warren, NJ or Cambridge, MA

Hybrid: 4 days per week onsite

Travel: As needed

Discover your role:

• Define the strategy to ensure standardization and consistency in execution of core activities (e.g., signal detection, authoring sections for safety documents) across all products and TAs through development of common practices, processes, templates
• Oversee relevant training programs for GPS Safety Sciences, including a standardized training curriculum, proficiency matrix, and knowledge management repository
• Enable the Global Capability Center (GCC) to operate more efficiency and scale with the demands of the business
• Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI

Operational Delivery Oversight

• Ensure compliance and quality management of Safety Sciences Operations activities, including compliance with all regulations and establishment of SOPs and associated monitoring tools
• Oversee all aspects of signal detection coordination and signal management process across all TAs, including Safety Monitoring Team (SMT), Safety Surveillance Plan (SSP) and Signal Evaluation Report (SER)
• Coordinate and 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
• Set and oversee the framework for aggregate safety data analysis to ensure effective coordination and delivery

Cross-Functional Partnership

• Serve as strategic point of contact to enable SS operational delivery in partnership with TAHs and GPS Leads
• Partner with key Regeneron interfaces (e.g., Clinical, Regulatory, Med Affairs, Biostats & Data Management)

Talent Development & Organizational Leadership

• Build, coach, and scale a high-performing team, and drive succession planning and talent pipelines
• Lead talent strategy and leadership development initiatives that strengthen capabilities across the organization.

This role requires:

• Minimum M.D., PA, PhD or PharmD Degree; Board Certification or equivalent in relevant clinical specialty, MBA is an advantage.
• 17+ years total experience in PV or relevant clinical experience in the pharmaceutical industry required
• 6+ years of leading a team and people management experience
• Preferred experience with oversight of operations within a global patient safety organization
• 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