Senior Manager, Clinical Lab Project Management

Regeneron Pharmaceuticals•Warren, MI

1d•Hybrid

About The Position

Regeneron is seeking a Senior 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 10 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, 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 Regeneron clinical trials.
Review clinical laboratory operations timelines and risks, and manage and communicate risks.
Ensure study starts and data delivery are aligned with expectations.
Serve as a subject matter expert on central and specialty laboratory processes.
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, including progress and schedules of testing/data generation across the portfolio with clear objectives and deadlines.
Manage strong relationships and trust with internal and cross-functional partners.
Demonstrate relevant knowledge and understanding of clinical laboratory trial requirements on the program and implement operational decisions.
Ensure the laboratory portion of the studies are harmonized for the assigned program from onset to final delivery.
Communicate with clinical study teams on laboratory program direction.
Demonstrate authority for the studies related to the program.
Create and communicate enhancements to Clinical Laboratory Project Management and connections through the matrix environment.
Design and develop processes to address identified gaps.