Manager, Global Site Start-Up Lead

Build Our Future Together The Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global execution of site activation for clinical trials, performing the role with moderate oversight to ensure efficient and compliant processes aligned with Regeneron SOPs, ICH-GCP guidelines, and industry standards. Partnering closely with cross‑functional teams and clinical research organizations (CROs), this role balances strategic oversight with hands‑on leadership to address challenges and deliver study objectives. The SSU Lead develops site activation projections, mitigates risks impacting site activation, monitors CRO performance, and leads all aspects of site start‑up activities, including fast‑track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision‑making. When & Where This in‑office role is located in either Warren, NJ or Armonk, NY. Responsibilities Site Start‑up Strategy Develop the site start‑up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks. Oversee tracking and analysis of study metrics, including risks and mitigation strategies, to evaluate CRO performance and implement corrective actions. Advocate for optimized site selection strategies, leveraging data‑driven insights to guide cross‑functional teams toward effective decision‑making. Lead the development, assessment, and alignment of site activation projections, ensuring cross‑functional and CRO collaboration to meet strategic objectives. Ensure comprehensive and compliant documentation of site start‑up materials in the Trial Master File (TMF) to maintain inspection readiness. Country Start‑up Partner with cross‑functional and CRO partners to develop a comprehensive global country start‑up strategy, outlining all dependencies impacting country start‑up and actively mitigating and escalating risks cross‑functionally. Monitor and maintain country intelligence data to support informed decision‑making and develop accurate start‑up projections and strategic plans. Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising CRO insurance requests. Ensure timely country submission deliverables with clear task completion, critical path identification, and effective communication. Site Start‑up Management Lead and oversee all aspects of site start‑up activities, including fast‑track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes. Serve as the subject‑matter expert for essential site documents, providing training, guidance, and support to teams and sites on regulatory requirements, document management, and TMF filing. Oversee CRO site start‑up management or, where applicable, in‑house site‑facing regional SSU team. Lead the collection and analysis of site intelligence to support strategic site selection and site start‑up. Oversee preparation and approval of site regulatory package, ensuring compliance with country‑specific requirements, TMF standards, and ICH‑GCP guidelines, while supporting inspection readiness and maintaining high‑quality site documentation. Team Interactions Represent SSU on cross‑functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start‑up issues. Act as the escalation point for CRO and internal teams to ensure timely SSU issue resolution. Process Improvement Recommend and participate in cross‑functional and departmental process improvements. This Role Requires A bachelor's degree and 6+ years of relevant experience. Demonstrated interpersonal and leadership skills. Ability to understand and implement the operational strategic direction for clinical studies. A data‑driven approach to planning, executing, and problem‑solving. Effective communication skills in verbal, written, and presentation contexts. Proactive and self‑disciplined, able to meet deadlines and prioritize tasks. Ability to influence and negotiate across key stakeholders. Ability to build productive study team collaborations. Experience in the clinical drug development process with expertise in study start‑up. Demonstrated vendor‑management experience. Technical proficiency in trial management systems (CTMS, TMF) and MS applications such as Project, PowerPoint, Word, and Excel. Knowledge of ICH/GCP and regulatory guidelines/directives. Effective project‑management skills, cross‑functional team interaction, and organizational skills. May require up to 25% travel. Benefits Regeneron offers a competitive and comprehensive total rewards package which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S. visit careers.regeneron.com/en/working-at-regeneron/total-rewards/. Equal Opportunity Employer 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. Salary Range (annually) $114,800.00 - $187,400.00 #J-18808-Ljbffr BioSpace