Build our future together: The Executive Director, Global Patient Safety Sciences, Rare Disease is the first point of contact for all Rare Disease strategy-related responsibilities across clinical, and post-marketed drugs in the portfolio. As the product subject matter expert (SME) and Therapeutic Area Head (TAH) for the Rare Disease portfolio, this role defines the product safety strategy, establishes the medical safety opinion, and provides the safety scientific POV across both GPS and non-GPS interactions. In addition, the position acts as a trusted advisor to senior management regarding safety strategies/processes while developing organizational objectives and, importantly, understanding the impact of decisions across functional areas. The ED Global Patient Safety Sciences Rare Disease is responsible for the development of their team, which is comprised of GPS Leads. They will serve as a member of the GPS Leadership Team (GPS LT). When & where: Work Location: Tarrytown, NY 4 days per week on-site 25% travel may be required Discover your role: Contribute senior-level safety expertise to clinical projects across assigned therapeutic area Act as a resource for medical review for complex ICSRs, and other data sources of assigned compounds and serves as point of escalation for ICSR causality assessments Provide oversight for safety signal evaluations & deliver clinical interpretation of emerging safety issues Review benefit-risk assessments (e.g., HHAs) written by Safety Sciences Delivery and recommendations for the product safety profile as appropriate for the stage of the asset lifecycle for safety responses to regulatory agency queries and safety documents (e.g., DSURs, PSURs) Develop innovative approaches to delivering on core activities that integrate in new technologies, including AI Governance Leadership Influence cross-functional leaders to align priorities and drive enterprise results Approve and provide medical oversight for Risk Management Plans (RMPs) Approve responses to medical & clinical health authority queries as needed Oversee cross-functional Safety Monitoring Team (SMT) activities Represent GPS at cross-functional governance meetings including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and with other parties external to Regeneron (e.g., collaborators) 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 preferred; 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, added benefit if in a matrixed environment Preferred 1-3 years of international pharmaceutical activities Proven track record in developing a deep understanding of the products’ safety profile, supported by in-depth product knowledge to inform safety assessments, risk evaluations, and decision-making Experience with oversight of strategy within a global patient safety organization 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 AI technologies #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. Salary Range (annually) $285,600.00 - $475,900.00 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.