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Clinical Lab Director – Part-Time
Spear BioPart-time Laboratory Director overseeing operations of CLIA-certified clinical laboratory for Spear Bio. Focused on clinical, scientific, and regulatory oversight to ensure accurate testing services.
About the role
Key responsibilities & impact- 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, as applicable.
- 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.
- Foster a culture of quality, compliance, and scientific excellence.
Requirements
What you’ll need- M.D., D.O., or Ph.D. in a relevant scientific discipline (e.g., immunology, pathology, clinical chemistry, biochemistry, molecular biology, or a related field)
- Qualified to serve as Clinical Laboratory Director of a high-complexity CLIA laboratory under applicable federal and Massachusetts state regulations -- Clinical Laboratory Director License issued by the Massachusetts Department of Public Health (MDPH) is required
- Board certification in a relevant discipline (e.g., Clinical Chemistry, Clinical Pathology, HCLD, Immunology, or other appropriate specialty) is required
- Minimum 8-10 years of experience in high complexity clinical laboratory operations, with at least 5 years in a director-level role overseeing a CAP/CLIA-certified laboratory.
- Proven track record of successfully establishing or scaling a clinical lab.
- Demonstrated expertise in immunoassay technologies (such as Immuno assay PCR, or digital ELISA), assay validation and verification.
- Strong knowledge of laboratory quality systems, proficiency testing, and inspection readiness.
- Experience with LIMS platforms, electronic quality management systems (eQMS), and workflow automation in a high-complexity testing environment.
- Experience working for a fast-paced, early-stage startup.
Benefits
Comp & perks- competitive compensation
- meaningful stock ownership
- comprehensive benefits
- great work environment
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
High-Complexity Clinical Laboratory OperationsAssay Validation and VerificationRegulatory ComplianceQuality Documentation ReviewContinuous Quality Improvement
Soft Skills
Clinical ConsultationLeadershipCollaboration
Certifications
M.D.D.O.Ph.D.Board Certification in Clinical PathologyHCLD Certification