Senior Manager Clinical Study Lead; Diabetes​/Obesity​/Metabolism

Senior Manager Clinical Study Lead (Diabetes/Obesity/Metabolism)

Join Regeneron as the Senior Manager Clinical Study Lead (CSL) for Diabetes, Obesity and Metabolism trials. The position is not eligible for full remote work; it requires on‑site presence at one of our locations with relocation support provided to qualified candidates.

• Lead the cross‑functional study team and serve as the primary point of contact for study oversight.
• Provide operational input into protocol development and study documentation such as case report forms, data management plans, monitoring plans, statistical analysis plans, etc.
• Oversee the setup and maintenance of study systems (CTMS, TMF, etc.) and ensure compliance with registry requirements.
• Identify outsourcing needs, engage and manage vendors, and contract with CROs.
• Contribute to baseline budget and timeline development and manage them throughout the study cycle.
• Lead risk assessment, mitigation planning, and feasibility assessments for study regions and countries.
• Oversee site evaluation, selection, activation, monitoring visits, and data quality monitoring.
• Manage study drug and clinical supplies forecasting, accountability, and reconciliation.
• Escalate issues related to conduct, quality, timelines, or budget to Program Operations Leaders and stakeholders, and drive corrective actions.
• Ensure audit and inspection readiness, support internal and external inspections, and contribute to CAPAs.
• Manage study close‑out activities (database lock, vendor contract reconciliation, TMF, drug accountability).
• Facilitate and contribute to study‑level lessons learned and process improvement initiatives.
• Support direct supervision of CTM staff, including task assignment, performance management, recruitment, development, and compliance oversight.
• May perform unmasked tasks for studies (e.g., masked product handling, IVRS supervision).
• Travel may be required up to 25% of the time.

• Exceptional interpersonal and leadership skills.
• Advanced expertise in operationally directing clinical studies.
• Expert knowledge with a data‑driven approach to planning, execution, and problem‑solving.
• Strong verbal, written, and presentation communication skills.
• Proactive, self‑disciplined time management and prioritization.
• Ability to influence and negotiate across diverse stakeholders.
• Strong budget management experience.
• Awareness of current industry trends.
• Skill in building, leading, and developing productive study teams.
• Advanced negotiation and interpersonal skills for vendor management.
• Advanced technical proficiency in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC).
• Extensive experience in global clinical trial operations, contributing to protocols and key study documents.
• Knowledge of ICH/GCP and regulatory guidelines.
• Advanced project management, cross‑functional team leadership, and organizational skills.
• Line‑management experience.

In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years of relevant clinical trial experience at a sponsor, CRO, or site.

• Prior experience in Obesity/Metabolism/Diabetes related trials.
• Extensive Phase III experience required.

Salary Range (annually): $ - $

Regeneron is an equal opportunity employer. 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.

Regeneron will provide reasonable accommodation to qualified applicants with disabilities or chronic illnesses unless it would impose undue hardship on the operation of the business.

Please note that certain background checks will be part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based.