Senior Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals • Warren, MI

25d • Onsite

About The Position

The Senior Manager, Precision Medicine Clinical Laboratory Operations is responsible for clinical laboratory project and program management across therapeutic areas. Working closely with the Director, Precision Medicine Clinical Laboratory Operations and cross-functional collaborators, this role keeps laboratory deliverables across the portfolio on track, ensures study-start timelines are met, and manages risk. The role supports early- and late-stage pipeline programs in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues, and central and specialty testing laboratories.

The position performs portfolio-level clinical laboratory management for clinical trials, tracks biomarker strategy delivery schedules, and coordinates laboratory goals, testing and data-generation schedules, and deadlines. It applies subject-matter expertise in central and specialty laboratory processes and clinical trial requirements to help ensure laboratory deliverables and study data meet expectations. The role also manages relationships with internal and cross-functional partners, harmonizes laboratory operations across assigned programs from study onset through final delivery, and develops process improvements to address identified gaps.

The role is based on-site in Warren, New Jersey, or Armonk, New York. If on-site, employees are expected to work on-site four days per week.

Requirements

• Bachelor’s degree required.
• At least 10 years of experience, preferably in the pharmaceutical or biotechnology industry, or in academic or governmental cross-disciplinary teams.
• At least 5 years of clinical trial experience, with a focus on clinical sample collection.
• Extensive experience in clinical laboratory operations, biospecimen logistics, and/or clinical study work.
• Strong understanding of the technical, clinical, and strategic aspects of laboratory operations delivery.
• Clinical study knowledge demonstrated through knowledge of science and technology.

Nice To Haves

• Master’s degree preferred.
• Experience in the pharmaceutical or biotechnology industry is preferred.

Responsibilities

• Manage clinical laboratory projects and programs across clinical trial portfolios and therapeutic areas.
• Review clinical laboratory operations timelines and risks; communicate and manage risks to keep study starts and data delivery aligned with expectations.
• Serve as a subject-matter expert on central and specialty laboratory processes and collaborate to ensure clinical laboratory deliverables.
• Keep biomarker strategy delivery schedules for clinical development programs and studies on track; identify and track risks and decisions and create mitigation plans.
• Manage clinical laboratory operations goals, progress, testing and data-generation schedules, objectives, and deadlines across the portfolio.
• Build and maintain strong relationships with internal and cross-functional partners, including Precision Medicine Clinical Lab Study Management and Precision Medicine Strategy Leads.
• Manage and implement program-level clinical laboratory management in collaboration with Global Development partners.
• Apply knowledge of clinical laboratory trial requirements and make operational decisions for programs.
• Ensure laboratory activities for assigned studies are harmonized from study onset through final delivery.
• Communicate laboratory program direction to clinical study teams and provide operational subject-matter expertise and authority for studies within the program.
• Develop and communicate enhancements to Clinical Laboratory Project Management and matrix connections, and design processes to address identified gaps.

Benefits

• 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, medical, dental, vision, life and disability insurance, paid time off, and family support benefits. Availability depends on country and role.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior