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Regeneron Pharmaceuticals

Executive Director, Global Patient Safety Sciences Delivery

Uxbridge
Posted 26 days ago
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Build our future together: 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. When & where: Work Location: Uxbridge, UK 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 #GDPSJobs Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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. 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. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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Skills

Pharmacovigilance
Patient Safety
Signal Detection
Risk Management
People Management
Cross-functional Leadership
Regulatory Compliance
Benefit-Risk Assessment
Strategic Planning
Operational Oversight
Talent Development
Clinical Research

Location

Uxbridge, England, United Kingdom

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