Senior Manager Clinical Study Lead; Clinical Experimental Sciences

This role is not eligible for remote work and must be onsite in one of our US office locations.

Senior Clinical Study Lead (CSL) – Clinical Experimental Sciences Operations (CES Ops) is accountable for the execution of assigned clinical studies and research collaborations from study design through execution to study close‑out. The Sr. CSL also oversees CES Ops continuous improvement and Strategic Imperatives work streams. The Sr. CSL is accountable for oversight of contract and budget execution, study timelines, budget management, and ensuring conduct is in accordance with Regeneron SOPs, CES Ops Business Practice Tool processes, and ICH/GCP as applicable.

The CES Ops portfolio includes a range of study types from simple data transfer agreements to complex prospective studies involving biomarker validation, genotypic/phenotypic call‑back studies, and challenge/screening studies. This role interfaces heavily with Basic Research/Discovery and clinical site staff at academic institutions. In rare instances, more complex studies may require outsourcing to Clinical Research Organizations (CROs); the balance of direct leadership versus oversight varies accordingly.

The Sr. CSL also drives ongoing process improvement initiatives and may be responsible for direct line management.

• Leads the cross‑functional study team responsible for clinical study delivery and is the primary point of contact for leadership and oversight as required.
• Provides operational input into research plan and/or study protocol development.
• Ensures development of study‑specific documentation such as sample management plans and data management plans are completed on time and in accordance with the protocol.
• Oversees setup and maintenance of study systems including the Clinical Trial Management System (CTMS), Trial Master File (TMF), and study SharePoint.
• Identifies outsourcing needs and leads engagement, contracting and management of required vendors when appropriate.
• Provides input into baseline timeline and budget development and management, and facilitates internal review of the study budget for assessment of Fair Market Value.
• Ensures accurate budget management and scope changes for internal and external studies.
• Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and implements appropriate actions to address issues.
• Oversees the execution of the clinical study against planned timelines, deliverables and budget.
• Ensures CROs and third‑party vendors are in alignment and delivering per scope of work.
• Manages and oversees study close‑out activities.
• Ensures End of Study Summary is delivered and properly archived.
• Facilitates and contributes to study‑level lessons learned.
• Assigns tasks to Clinical Study Management staff and supports their deliverables.
• Recommends and participates in cross‑functional and departmental process improvement initiatives.
• Identifies innovative approaches to clinical study execution including global considerations and continuous improvement departmental processes and procedures.
• Works with Therapeutic Focus Area groups within Basic Research/Discovery.
• Works closely with clinical site staff, predominantly at academic institutions.
• Maintains higher volume and/or greater complexity studies.
• Communicates learnings, best practices and relevant information to other study leads at all levels, ensuring consistency and internal alignment across staff.
• May be responsible for direct supervision of CTM staff, including work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight.

A minimum of a Bachelor’s degree and eight (8) years of relevant clinical experience is required.

$ – $

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.

Where required, reasonable accommodation will be provided to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.