Clinical Laboratory Project Manager

Regeneron Pharmaceuticals•Warren, MI

7d•Hybrid

About The Position

The Clinical Lab Project Manager is responsible for program-level oversight of biomarker and clinical laboratory operations within Precision Medicine. The individual provides planning and operational leadership—proactively managing various strategic forums, quality, timelines, vendors, and risk—for the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP, and company Standard Operating Procedures within assigned programs. The role leads strategy, planning, and continuous-improvement efforts for the function and is a member of the Precision Medicine Clinical Laboratory Operations leadership team, interfacing with senior leadership across Global Development.

Requirements

Bachelor’s degree and 10+ years of relevant industry experience, preferably in a pharmaceutical or biotech environment or in academic or governmental cross-disciplinary teams.
Experience with working alongside clinical trials—with a focus on continuous improvement and clinical laboratory operations decision making and alignment.
Demonstrated process improvement and experience in strategic planning, vendor strategy and governance, risk mitigation, leading internal and external meetings, and complex operational solutioning is essential.

Responsibilities

Maintain a program-level overview of clinical laboratory status and issues; proactively communicate progress, risks, issues, or changes that may impact quality, timelines, and/or budget, and provide program-level updates to stakeholders as requested.
Oversee clinical laboratory timelines across the assigned program(s); review plans and provide clinical laboratory operations decision making per the clinical laboratory strategy for early lab engagement, study start-up, and conduct phases, ensuring study starts and data delivery are aligned with decision making.
Ensure timely delivery of operational deliverables and accountability for consistency of process and approach across clinical study teams within programs.
Lead and facilitate strategic forums, planning, and operations efforts for the function—including objective and goal setting, organizational planning for vendor visits, lab leadership, and cross-functional business reviews for assigned program(s).
Support functional laboratory strategy and allocation, translational meetings, IVDR committee workflows, budget management for the program(s), liaising with cross-functional leadership and finance, and review key metrics and Key Performance Indicators to track progress and drive action plans to address issues.
Build trusted relationships with internal and cross-functional partners and senior leadership—including Precision Medicine Clinical Lab Study Management, Precision Medicine Strategy Leads, and Global Development—and communicate program direction to internal teams, providing frequent executive summaries while remaining able to dive into detail when required.
Bridge laboratory clinical trial operations across research, translational medicine teams and tech centers at Regeneron, managing timelines for lab delivery in clinical trials and other human-sample projects to ensure seamless execution and adherence to commitments.
Drive decision making and lead program direction, delivery, and implementation of strategic change and continuous-improvement initiatives for Precision Medicine Operations; including but not limited to samples/assays within the protocols, timeline management for operations, translational medicine initiatives.
Incorporate industry best practices and innovation to keep operations current and practical.