Medical Laboratory DirectorWaltham, MA

CareDx is a leading precision medicine diagnostics company advancing care in transplant, specialty oncology, and cell therapy. Through our innovative portfolio of molecular diagnostics, digital health solutions, AI-powered data and analytics, and patient support services, we partner with healthcare providers, patients, and biopharma organizations to help inform clinical decision-making and improve patient outcomes.

We are seeking a Medical Laboratory Director - CLIA Laboratory to provide clinical, scientific, regulatory, and administrative leadership for high-complexity CLIA laboratory operations. This Director-level role is responsible for ensuring the quality, accuracy, compliance, and timely delivery of laboratory testing services while supporting a culture of quality, collaboration, and continuous improvement.

The Medical Laboratory Director will provide oversight of laboratory testing activities, interpretation of test results, consultation with physicians and other healthcare providers, and guidance to laboratory professionals. This leader will help ensure that laboratory results are accurate, reliable, and available in a timely manner to support patient care.

This role will partner closely with Laboratory Operations and cross-functional stakeholders to support laboratory performance, quality assurance, regulatory compliance, staffing, budgeting, technology evaluation, and continuous process improvement. The position requires strong collaboration with laboratory operations, clinical, scientific, technical, regulatory, and corporate teams to advance company objectives and enhance patient care.

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.

Minimum Education, Experience, & Specialized Knowledge (Required):

Education and Certifications

• Ph.D. in a relevant scientific field such as chemistry, biology, clinical laboratory science, medical technology, or a related discipline.
• M.D., D.O., or M.D. with eligibility to hold valid Massachusetts and North Carolina medical licenses preferred.
• 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.
• Eligibility to hold a Certificate of Qualification in Oncology, Molecular and Cellular Tumor Markers issued by the New York State Department of Health preferred.

Experience

• 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.

Knowledge, Skills, and Abilities

• In-depth knowledge of oncologic pathology, clinical laboratory operations, laboratory regulations, quality systems, and high-complexity molecular diagnostics.
• Strong working knowledge of local, state, and federal laboratory regulations applicable to medical diagnostic testing.
• Demonstrated ability to lead a diverse team of laboratory professionals and build a strong laboratory culture centered on quality, collaboration, engagement, and patient care.
• Excellent interpersonal, communication, training, and relationship-building skills, with the ability to work effectively across multiple disciplines.
• Highly organized, detail-oriented, and committed to strong documentation practices.
• Results-oriented leader with strong integrity, sound judgment, and a commitment to quality.
• Ability to work effectively in a fast-paced, evolving corporate environment and adapt quickly to changing priorities.
• Ability to collaborate cross-functionally with non-laboratory and non-scientific personnel to advance company objectives and enhance patient care.

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