Job Summary The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety‑related issues for the compound(s)/asset(s) assigned within a given therapeutic area (TA). It is the GPS representative on the cross‑functional Strategic Program Team (SPT) for the compound, leading the safety strategy and ensuring optimal support from within GPS and working collaboratively with stakeholders to deliver that strategy. This position requires the ability to work with and influence colleagues in a matrix environment, including senior management. The GPS Director joins Regeneron’s industry‑leading scientific organization and has a direct impact on drug development, operations, and commercialization in all relevant global territories. Responsibilities Directly responsible for all aspects of Global Patient Safety activities for assigned compounds and products, supporting safety surveillance, signal management, communication of the safety profile, benefit‑risk assessment, safety responses to regulatory agency queries, and the preparation of safety documents (DSURs, PSURs, development RMPs, RMPs, etc.) as well as reviewing clinical documents (investigator brochures, protocols, clinical study reports, etc.). Lead cross‑functional Safety Monitoring Team (SMT) activities. Represent Global Patient Safety for assigned compounds on cross‑functional teams, including Regeneron’s Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), Strategic Program Team (SPT), and external teams with alliance partners and CROs. Proactively identify and develop safety strategies and planning for non‑compound specific Global Patient Safety activities (e.g., mechanism of action). Act as a resource for medical review of complex International Case Safety Reports (ICSRs) and other data sources of assigned compounds. Participate in the development and maintenance of relevant SOPs, working practices, and guides. Engage in continuous improvement activities within both the therapeutic area and the GPS organization, cultivating cross‑functional relationships and mentoring junior safety scientists. Qualifications Minimum 10+ years of total relevant experience in pharmacovigilance (PV) and/or a relevant medical field, or equivalent industry experience in drug safety, including significant experience with PSURs/DSURs/RMPs or in clinical development with demonstrated achievements in safety (e.g., supporting an ISS; responsible for CSR content). At least 5+ years of total relevant experience in PV and/or a relevant medical field with a PharmD, Ph.D., or M.D. degree. Proven ability to lead and develop a diverse team of Safety Professionals in a constructive, goal‑oriented environment. Strong ability to work across organizational levels, effectively communicating safety viewpoints and findings, and recommending risk‑management and minimization activities. Ability to apply and provide critical analysis of relevant FDA, EU, and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post‑marketing environments. Ability to utilize GPS safety database for medical case review and simple queries. Clinical experience and/or industry experience in oncology is a plus. Benefits Health and wellness programs (medical, dental, vision, life, and disability insurance) Fitness centers 401(k) company match Family support benefits Equity awards Annual bonuses Paid time off and paid leaves (e.g., military and parental leave) for eligible employees at all levels Compensation Salary Range (annually): $205,000.00 – $341,600.00 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr