Clinical Lab Director (Part-Time)

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, 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.

Qualifications

• 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.

Pay

Competitive compensation.

Schedule

Part-time.

Benefits

Comprehensive benefits.

Skills

Leadership, scientific excellence, regulatory compliance, quality management, clinical consultation, laboratory operations, immunoassay technologies, assay validation and verification, LIMS platforms, eQMS, workflow automation.

Benefits

Equal opportunity employer.