Executive Director, Global Patient Safety Sciences Delivery
Position Overview
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).
Responsibilities
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 efficiently and scale with the demands of the business.
Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI.
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).
Care for 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.
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).
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.
Qualifications
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.