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Medical Laboratory Director

CareDx· LAB
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Hybrid (Waltham, MA)$142k - $185kPosted 2mo ago

About the role

Medical Laboratory Director - CLIA Laboratory leading high-complexity molecular diagnostics operations in CareDx's Specialty Oncology division, focused on HPV-driven cancers and NavDx testing. Provides clinical, scientific, regulatory, and administrative leadership to ensure quality, compliance, and timely delivery of laboratory testing services, with collaboration across operations, clinical, regulatory, and corporate teams.

Responsibilities

  • Provide clinical, scientific, regulatory, and administrative oversight for high-complexity CLIA laboratory testing services.
  • Ensure laboratory operations and testing services comply with applicable regulatory and accreditation requirements, including CLIA, CAP, NY State CLEP, and other relevant regulatory bodies.
  • Ensure testing systems, methodologies, and laboratory processes provide accurate, reliable, and high-quality results across the pre-analytic, analytic, and post-analytic phases of testing.
  • Provide clinical interpretation of laboratory test results and consultation to ordering physicians, patients, and other healthcare providers as appropriate.
  • Oversee quality assurance and quality control programs to monitor laboratory performance, identify quality issues, and support timely corrective and preventive actions.
  • Ensure proficiency testing is performed in accordance with CLIA and other applicable requirements.
  • Ensure acceptable levels of analytical performance are established and maintained for each test system.
  • Ensure appropriate documentation of remedial actions when deviations from established performance specifications are identified, and ensure patient results are reported only when systems are functioning properly.
  • Maintain awareness of current and future laboratory accreditation standards and ensure duties are performed consistent with applicable regulatory expectations.
  • Participate in laboratory-related managerial decisions, including staff selection, test methods, equipment purchases, quality systems, safety, regulatory compliance, hours of operation, scheduling, and utilization management.
  • Partner with the head of Laboratory Operations on laboratory strategy, budgeting, resource planning, technology evaluation, and operational improvements.
  • Support the development, validation, and implementation of laboratory testing processes and methods in a high-complexity molecular diagnostics environment.
  • Ensure the laboratory environment, physical plant, and safety conditions are appropriate for the testing performed and provide a safe work environment.
  • Ensure approved procedure manuals are available to personnel responsible for all aspects of the testing process.
  • Lead, mentor, and support laboratory professionals, fostering a culture of quality, accountability, collaboration, high morale, and engagement.
  • Collaborate cross-functionally with laboratory, clinical, scientific, operations, technology, and corporate teams to support company objectives and patient care.
  • Establish and maintain effective communication with internal and external stakeholders to support laboratory service needs, clinical trends, and program planning.
  • Perform other responsibilities required by CLIA and other applicable local, state, federal, or accreditation requirements.
  • Required travel is <20%

Qualifications

  • M.D./D.O., and/or Ph.D. in a relevant scientific field such as chemistry, biology, clinical laboratory science, medical technology, or a related discipline.
  • Eligible to hold valid Massachusetts, North Carolina, and California director licenses required.
  • Qualification under the personnel regulations of the Clinical Laboratory Improvement Amendments of 1988 required.
  • ABCC, ABMGG, and/or ABB certification strongly desired.
  • Certification by the American Board of Pathology in Anatomic Pathology and/or Clinical Pathology preferred.
  • ABP certification in Molecular Genetic Pathology preferred.
  • Current Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers and eligible for Certificate of Qualification in Genetic Testing issued by the New York State Department of Health
  • At least 10 years of experience in a high-complexity CLIA laboratory focused on molecular diagnostics, including at least 5 years in a leadership role.
  • Demonstrated experience overseeing the scope, standards, and quality of clinical testing services.
  • Experience with all phases of developing, validating, and implementing high-complexity molecular testing in a CLIA environment.
  • Experience in molecular diagnostics, gene expression platforms, real-time PCR, and next-generation sequencing preferred.
  • Participation in clinical activities of multidisciplinary cancer care with the ability to communicate directly with treating physicians and patients.
  • Experience evaluating laboratory programs, solving complex problems, and building strong cross-functional relationships.

Skills

Required:Clinical laboratory leadershipRegulatory compliance (CLIA, CAP, NY CLEP)Quality assurance and controlMolecular diagnosticsClinical interpretation of results
Last updated Aug 12, 2026. Interested? Apply on the company site.
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CareDx delivers transplant-focused diagnostics, digital health tools, and services that support patients and clinicians across the entire transplant journey.

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