Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals•Warren, MI

1d•Hybrid

About The Position

Regeneron is seeking a Manager, Precision Medicine Clinical Laboratory Operations to be responsible for Clinical Laboratory Project & Program management for various therapeutic areas. This role will work closely with the Director, Precision Medicine Clinical Laboratory Operations and key cross-functional collaborators. The primary responsibility is to keep laboratory deliverables across the portfolio on track, ensuring study start timelines are met and providing risk management. This will be achieved in collaboration with Precision Medicine Strategy Leads, Clinical Trial Management, Clinical Laboratory Operations Management, Global Development colleagues, and central and specialty testing laboratories to support early and late-stage programs within the pipeline.

Requirements

Bachelors degree required.
Minimum of 8 years experience preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams.
Minimum of 5 years’ experience with Clinical Trials, with a focus on clinical sample collection.
Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience.
Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery.
Clinical study knowledge, demonstrated by knowledge in science and technology.

Nice To Haves

Masters degree preferred.

Responsibilities

Perform clinical laboratory portfolio management for complex Regeneron clinical trials.
Review clinical laboratory operations timelines and risks, and manage/communicate these risks to ensure study starts and data delivery align with expectations.
Maintain active knowledge of central and specialty laboratory processes to act as a trusted collaborator and ensure clinical laboratory deliverables.
Track biomarker strategy delivery schedules for clinical development programs/studies, identifying and tracking risks and decisions, and creating mitigation plans.
Oversee clinical laboratory operations goals, including progress and schedules of testing/data generation across the portfolio with clear objectives and deadlines.
Liaise with internal and cross-functional partners, including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads, and others within Global Development to manage and implement program-level clinical laboratory management.
Demonstrate understanding of complex non-oncology clinical laboratory trial requirements on the program and implement operational decisions and harmony.
Communicate with clinical study teams on laboratory program direction and demonstrate knowledge for the studies related to the program.