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About the Role
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 for the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP, and company Standard Operating Procedures. 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.
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.
- Oversee clinical laboratory timelines across 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.
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.
- Background checks may be conducted in accordance with the laws of the country where the position is based to verify information prior to employment commencement.
Location
- Armonk, NY
- Warren, NJ
- Remote, USA
Work Type
- Hybrid
Education Level
- Bachelor's degree
Salary/Compensations
- $114,800.00 - $187,400.00
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- We are committed to building a workplace with an inclusive culture.
- Regeneron offers a competitive and comprehensive total rewards package.
- We believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.