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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical laboratory operations, strategic planning, and process improvement, with a strong focus on managing timelines and delivering operational excellence in clinical trials. Proven ability to communicate effectively with cross-functional teams and senior leadership while ensuring compliance with industry regulations.
Highest-signal resume keywords
Clinical Laboratory OperationsStrategic PlanningProcess ImprovementRisk MitigationVendor Strategy
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trials ManagementOperational DeliverablesKPI ReviewDecision MakingBudget Management
Soft Skills
CommunicationRelationship BuildingLeadershipFacilitationCollaboration
Industry Keywords
PharmaceuticalBiotechICH/GCPStandard Operating ProceduresTranslational Medicine
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Maintain a program-level overview of clinical laboratory status and issues
- Communicate progress, risks, issues, or changes affecting quality, timelines, and budget
- Oversee clinical laboratory timelines across assigned programs
- Review plans and provide clinical laboratory operations decision making for early lab engagement, study start-up, and conduct phases
- Ensure timely delivery of operational deliverables and consistency of processes across clinical study teams
- Lead and facilitate strategic forums, planning, and operational efforts
- Set objectives and goals and support organizational planning for vendor visits, lab leadership, and cross-functional business reviews
- Support laboratory strategy and allocation, translational meetings, IVDR committee workflows, and program budget management
- Review key metrics and KPIs and drive action plans to address issues
- Build relationships with internal, cross-functional, and senior leadership partners
- Communicate program direction and provide executive summaries while maintaining operational detail
- Bridge clinical trial laboratory operations across research, translational medicine teams, and technology centers at Regeneron
- Manage laboratory delivery timelines for clinical trials and human-sample projects
- Drive decision making and lead program direction, delivery, implementation of strategic change, and continuous-improvement initiatives
- Incorporate industry best practices and innovation into operations
Requirements
What you’ll need- Bachelor’s degree
- 10+ years of relevant industry experience
- Preferably experience in a pharmaceutical or biotech environment or in academic or governmental cross-disciplinary teams
- Experience working alongside clinical trials, with a focus on continuous improvement and clinical laboratory operations decision making and alignment
- Demonstrated process improvement experience
- Experience in strategic planning, vendor strategy and governance, risk mitigation, leading internal and external meetings, and complex operational solutioning
- Work in accordance with applicable regulations, ICH/GCP, and company Standard Operating Procedures
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses, where required