Clinical Lab Director

About the Company

Spear Bio is a well-funded and rapidly growing biotech start-up dedicated to revolutionizing early disease diagnosis and monitoring. Their proprietary SPEAR technology is a novel wash-free immunoassay platform offering unprecedented sensitivity for measuring low-abundant biomarkers.

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