Senior Manager, Clinical Study Lead, Internal Medicine

Build our future together: At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. Senior Clinical Study Lead (CSL) – you will lead and oversee the global execution of large and/or complex clinical trials from study design to close‑out, ensuring timelines, budgets, and compliance with Regeneron SOPs and ICH/GCP. Work Location Armonk, NY; Warren, NJ – Hybrid; 4 days per week on site. Travel may be required (up to 25%). Key Responsibilities Lead the cross‑functional study team and serve as the primary point of contact for leadership and oversight. Oversee and contribute to study documents such as case report forms (CRF), data management plan, monitoring plan, statistical analysis plan, and more. Set up and maintain study systems, including the Clinical Trial Management System (CTMS) and Trial Master File (TMF). Identify outsourcing needs, engage vendors, and manage contracting and vendor oversight. Assist in baseline budget and timeline development and monitoring. Lead risk assessment, identify mitigation strategies, and assess feasibility for region and country selection. Monitor site activation, monitoring visits, data entry, query resolution, and recruitment/retention strategies, acting on any deviations from plan. Support study drug and clinical supplies forecasting, accountability, and reconciliation. Escalate issues related to conduct, quality, timelines or budget to the Program Operations Leader (POL) and appropriate stakeholders, and implement corrective actions. Manage study close‑out activities, including database lock, vendor contract reconciliation, TMF, budget, and drug accountability. Provide direct supervision of CTM staff, including assignments, performance management, recruitment, and professional development. Qualifications Bachelor’s degree (or higher) and a minimum of 8 years of relevant clinical trial experience. Extensive experience in global clinical trial operations, with knowledge of protocol development and key study documents. Line‑management experience with strong interpersonal, leadership and mentoring skills. Proactive, self‑disciplined, and able to meet deadlines with effective prioritization. Excellent influence and negotiation skills across diverse stakeholders. Advanced technical proficiency with trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC). Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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. We provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc (USA)