Medical Laboratory Director

About the role

CareDx is seeking a Medical Laboratory Director - CLIA Laboratory to provide clinical, scientific, regulatory, and administrative leadership for high-complexity CLIA laboratory operations.

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.
• 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.

Requirements

• 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.
• 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.

Qualifications

• 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.
• Able to work effectively in a fast-paced, evolving corporate environment and adapt quickly to changing priorities.
• Able to collaborate cross-functionally with non-laboratory and non-scientific personnel to advance company objectives and enhance patient care.