CAP Laboratory Director (Clinical Trial Laboratory)
Core
Provide scientific, medical, and regulatory leadership for high-complexity laboratories supporting clinical research and trials, ensuring compliance with CLIA, CAP, GLP, and GCP/GCLP standards.
Role type
Senior IC Clinical Trial Laboratory Director
Builds
Clinical trial laboratory operations and data integrity for biomarker, pharmacokinetic, immunogenicity, genetic, and flow-cytometry endpoints
Domain
Life sciences / Clinical diagnostics / Regulatory compliance
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CLIA high-complexity director qualifications, CAP accreditation oversight, GCP/GCLP compliance, method validation, assay lifecycle management, regulatory documentation, personnel competency assessment, data integrity management, LIS management, multi-state licensure navigation
Preferred skills
Experience with EU IVDR, global multi-site clinical trial networks, biomarker strategy, interaction with sponsors/CROs/regulatory authorities
Technologies
Laboratory Information Systems (LIS), eCRF systems
Responsibilities
Serve as legally accountable CLIA High-Complexity Laboratory Director, oversee CAP accreditation inspections, review and approve test methods and analytical plans, ensure GCP-compliant chain-of-custody and blinding, oversee proficiency testing and quality control, manage personnel qualifications and competency assessments
Seniority
Senior, hands-on IC with executive oversight