Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals•Warren, MI
•Onsite

About The Position

The Manager, Clinical Lab Project Management is responsible for clinical laboratory project and program management across therapeutic areas and clinical development programs. Working closely with the Director, Precision Medicine Clinical Laboratory Operations and cross-functional collaborators, this role keeps laboratory deliverables on track, supports study-start timelines, and manages risks. The work 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 is based on-site in Warren, New Jersey, or Armonk, New York. On-site employees are expected to work in the office four days per week.

Requirements

  • Bachelor’s degree required.
  • At least 8 years of experience, preferably in the pharmaceutical or biotech 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.

Responsibilities

  • Manage clinical laboratory portfolios for complex clinical trials and review laboratory operations timelines and risks.
  • Communicate and manage risks to support study starts and data delivery in line with expectations.
  • Use knowledge of central and specialty laboratory processes to collaborate and support clinical laboratory deliverables.
  • Track biomarker strategy delivery schedules for clinical development programs and studies; identify and track risks and decisions, and develop mitigation plans.
  • Oversee clinical laboratory operations goals, including portfolio progress, testing schedules, and data generation, with clear objectives and deadlines.
  • Liaise with internal and cross-functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads, and Global Development colleagues, to manage and implement program-level clinical laboratory management.
  • Understand complex non-oncology clinical laboratory trial requirements and implement operational decisions and coordination.
  • Communicate laboratory program direction to clinical study teams and demonstrate knowledge of studies related to the program.

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, insurance benefits, paid time off, and family support benefits.
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