Clinical Lab Director
Remotedxb
Responsibilities
- Serve as the CLIA Laboratory Director for Spear Bio’s high-complexity clinical laboratory
- Provide overall clinical, scientific, and regulatory oversight of CLIA-certified laboratory operations
- Ensure compliance with all applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP
- Oversee quality management program to ensure accurate, reliable, and timely laboratory testing
- Review and approve laboratory policies, procedures, test validations, and quality documentation
- Monitor laboratory performance and implement continuous quality improvement initiatives
- Provide clinical consultation to physicians and other healthcare providers regarding laboratory testing and test results
- Support laboratory readiness for regulatory inspections and accreditation surveys
Requirements
- M.D., D.O., or Ph.D. in a relevant scientific discipline
- Clinical Laboratory Director License issued by the Massachusetts Department of Public Health (MDPH)
- Board certification in a relevant discipline (e.g., Clinical Chemistry, Clinical Pathology, HCLD, Immunology)
- 8-10 years of experience in high complexity clinical laboratory operations
- 5 years in a director-level role overseeing a CAP/CLIA-certified laboratory
- Expertise in immunoassay technologies and assay validation
- Experience with LIMS platforms and electronic quality management systems (eQMS)
- Experience working for a fast-paced, early-stage startup
Vacancy posted 2 days ago
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