Medical Laboratory Director

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. Within CareDx's Specialty Oncology business, we are focused on improving the management of HPV-driven cancers through innovative diagnostic solutions. NavDx®, our blood-based DNA test, helps clinicians detect molecular signs of disease recurrence, monitor treatment response, and guide patient management throughout the care journey. Our team is committed to expanding access to actionable insights that support more informed cancer care. 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…