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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical laboratory operations, regulatory compliance, and quality management, with a strong focus on immunoassay technologies and laboratory performance improvement. Holds necessary qualifications and certifications to lead a high-complexity CLIA laboratory effectively.
Highest-signal resume keywords
Clinical Laboratory Director LicenseBoard Certification in Clinical ChemistryImmunoassay Technologies ExpertiseQuality Management Systems KnowledgeLIMS Platform Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
High-Complexity Clinical Laboratory OperationsAssay Validation and VerificationRegulatory ComplianceQuality Documentation ReviewContinuous Quality Improvement
Soft Skills
Clinical ConsultationLeadershipCollaboration
Tools & Technologies
LIMS PlatformsElectronic Quality Management SystemsWorkflow Automation
Certifications & Qualifications
M.D.D.O.Ph.D.Board Certification in Clinical PathologyHCLD Certification
Industry Keywords
CLIACAPNY State CLEPImmunologyClinical Chemistry
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