Clinical Lab Director (Part-Time)

Spear Bio, founded in 2021, is a well-funded and rapidly growing biotech start-up headquartered in Woburn, Massachusetts.  Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), is a novel wash-free immunoassay platform, offering unprecedented sensitivity. We are dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable, ultrasensitive solutions that deliver unparalleled accuracy in measuring low-abundant biomarkers, enabling clinicians and researchers to improve patient outcomes and advance global health.

Spear Bio is seeking a part-time Laboratory Director to support the establishment, certification, and operation of our CLIA-certified laboratory in Massachusetts. The Laboratory Director will provide clinical, scientific, and regulatory oversight to ensure Spear Bio delivers accurate, reliable, and high-quality testing services in compliance with applicable regulatory and accreditation requirements, including CLIA, CAP, and other applicable state requirements.

The Laboratory Director will be responsible for overseeing laboratory QMS, ensuring appropriate validation and performance of immunoassay testing methods, reviewing laboratory procedures, and supporting continuous improvement initiatives. This role provides clinical and technical guidance for test interpretation, quality assurance and regulatory compliance.

This is a consulting role intended to support Spear Bio’s CLIA/CAP certification readiness and early clinical laboratory operations. The Laboratory Director may delegate specific duties to qualified personnel but retains the ultimate responsibility for ensuring these duties are properly performed and documented.

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.

We offer competitive compensation, meaningful stock ownership, comprehensive benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage and play an integral role in the company's growth and success. We are focused on identifying candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of building an industry-leading company.

Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.

Spear Bio does not accept resume submissions from external recruiting agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of Spear Bio, and no placement fees will be paid.