CAP Laboratory Director (Clinical Trial Laboratory)

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies believes that it is a global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It is also one of the market leaders in certain testing and laboratory services for genomics, and in the support of clinical studies, as well as in biopharma contract development and manufacturing. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to ca. 63,000 staff across a decentralized and entrepreneurial network of more than 950 laboratories in 60 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2025, Eurofins generated total revenues of EUR 7.296 billion ($8.596 billion), and has been one of the best performing stocks in Europe over the past 20 years. Role Summary:  The Clinical Trial Laboratory Director provides scientific, medical, and regulatory leadership for high‑complexity laboratories supporting clinical research and clinical trials. This role ensures full compliance with CLIA requirements, including director qualifications and oversight responsibilities—and maintains CAP accreditation standards while meeting state-specific director/licensure requirements in multiple states, including Pennsylvania, New York, Rhode Island, Maryland, and California. The Director ensures assay validity, data integrity, patient‑subject safety, GDP, GLP. and GCP/GCLP‑aligned laboratory conduct throughout the lifecycle of clinical trials. Key Responsibilities 1. Regulatory, Trial, and Accreditation Leadership Serve as the legally accountable CLIA High‑Complexity Laboratory Director and maintain qualifications per 42 CFR §493.1443. Provide executive oversight of CAP accreditation, including biennial inspections, self‑inspections, and adherence to CAP checklist requirements. Ensure all laboratory operations supporting clinical trials meet CLIA, CAP, GLP, ICH‑GCP, and GCLP expectations for accuracy, integrity, and traceability. Oversee trial‑specific regulatory documentation, method validations, equipment qualifications, and assay change controls consistent with CAP validation/verification principles. 2. Clinical Trial Scientific Oversight Review and approve test methods, protocols, analytical plans, policies, procedures, and assay validations specific to clinical trial endpoints. Ensure test systems are suitable for the study population and meet clinical trial protocol requirements, consistent with CLIA’s requirement for appropriate test systems and reliable data. Serve as scientific liaison to sponsors, CROs, principal investigators, and regulatory authorities regarding laboratory capabilities, biomarker strategies, and test result interpretation. 3. Quality Management & Data Integrity Adhere to Quality in accordance with the ECL Quality Management System supporting clinical trial labs, including document control, method validation, instrument qualification, and ongoing competency assessments. Oversee proficiency testing (PT), quality control, and data integrity processes for trial‑critical assays, meeting CLIA/CAP expectations for PT integration and evaluation. Approve CAPA plans and deviations relevant to clinical trials and ensure compliance with protocol‑specific quality and audit requirements. Oversee day to day function of Laboratory and Specimen Management operations. Adhere to adequate Private Health Information (PHI) practices and policies. 4. Clinical Trial Operational Oversight Ensure laboratory workflows support GCP‑compliant chain‑of‑custody, blinding, documentation, metadata capture, and audit trails. Partner with project management teams to ensure lab readiness, study start‑up timelines, sample logistics, and database lock requirements. Oversee Laboratory Information System (LIS) and study‑specific data integrations supporting sample tracking, eCRF data flows, and regulatory compliance, aligned with CAP expectations for LIS management. 5. Personnel & Competency Ensure all laboratory staff involved in clinical trial testing meet CLIA/CAP qualifications and any elevated state requirements (NY CQ categories, CA LFS licensure, etc.). Provide oversight of personnel competency assessments and continuing education tied to trial‑specific techniques. (General competence requirement) Support training in GCP/GCLP, protocol adherence, and data integrity. Required Qualifications Federal (CLIA High‑Complexity Director Requirements) Must meet one of the 42 CFR §493.1443 qualification pathways: MD/DO with state medical license and board certification in anatomic/clinical pathology (ABP/AOBP); or MD/DO/DPM with ≥2 years high‑complexity lab director/supervisor experience + ≥20 CE hours in director responsibilities; or PhD or equivalent with HHS‑approved board certification (e.g., ABB, ABCC, ABMM, ABMLI) + required leadership experience + ≥20 CE hours. State Requirements (must meet the most stringent) New York: Approved CQ categories for all testing performed; adherence to NY onsite/time requirements and director limits. Pennsylvania: Qualifications per 28 Pa. Code §5.21. California: Active LFS Laboratory Direc