Role Overview Senior Clinical Study Lead (CSL) – Clinical Experimental Sciences Operations (CES Ops). The role is not eligible for remote work and must be onsite in one of Regeneron's U.S. office locations. Accountable for the execution of assigned clinical studies or research collaborations from study design, through execution, to study close‑out. Supports initiation, oversight, and completion of CES Ops continuous improvement and Strategic Imperatives workstreams. Responsible for oversight of the contract and budget execution, study timelines, study budget management, and ensuring study conduct complies with Regeneron SOPs, CES Ops Business Practice Tool processes and ICH/GCP, as applicable. Responsibilities Lead the cross‑functional study team responsible for clinical study or research collaboration delivery and serve as the primary point of contact for leadership and oversight. Provide operational input into research plan and/or study protocol development. Ensure development of study‑specific documentation such as sample management plans and data management plans are completed on time and in accordance with the study protocol. Oversee the set‑up and maintenance of study systems, including Clinical Trial Management System (CTMS), Trial Master File (TMF), and study SharePoint. Identify outsourcing needs for the study, lead and oversee engagement, contracting and management of required vendors when appropriate. Contribute to baseline timeline and budget development and management, facilitate internal review of the study budget for Fair Market Value assessment, and manage accurate budget and scope changes for internal and external studies. Escalate issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders, and develop and implement appropriate actions to address issues. Oversee execution of the clinical study against planned timelines, deliverables and budget, ensuring CROs and third‑party vendors deliver per scope of work. Manage and oversee study close‑out activities and ensure the End of Study Summary is delivered and properly archived. Facilitate and contribute to study‑level lessons learned, assign tasks to Clinical Study Management staff and support their deliverables. Recommend and participate in cross‑functional and departmental process improvement initiatives, identify innovative approaches to clinical study execution, including global considerations and continuous improvement of departmental processes and procedures. Work with Therapeutic Focus Area groups within Basic Research/Discovery and work closely with clinical site staff, predominantly at academic institutions. Maintain higher volume and/or greater complexity studies, communicate learnings, best practices and relevant information to other study leads at all levels, and ensure consistency and internal alignment across staff. May be responsible for direct supervision of CTM staff, including work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight. Qualifications A bachelor’s degree and a minimum of 8+ years of relevant clinical experience. Benefits and Compensation Salaries for the U.S. based position range from $150,500.00 to $245,500.00 annually. Benefits vary by location and may include health, 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 such as military and parental leave. Background Checks Background checks may be part of the recruitment process and will be conducted in accordance with the laws of the country where the position is based. 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, 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 veterancy status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will provide reasonable accommodation for known disabilities or chronic illnesses unless the accommodation would impose undue hardship on the operation of the business. #J-18808-Ljbffr