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Medical Laboratory Director

Caredxinc • Waltham, MA

Job Description

<div class="content-intro"><p><span style="font-family: times new roman, times, serif;"><span style="font-size: 16px;"> </span></span></p></div><p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <div class="x_x_elementToProof"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span data-olk-copy-source="MessageBody">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.</span></span></div> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">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.</span></p> <p><span style="font-family: 'times new roman', times, serif; font-size: 12pt;"><strong>Responsibilities: </strong></span></p> <ul> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Provide clinical, scientific, regulatory, and administrative oversight for high-complexity CLIA laboratory testing services.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure laboratory operations and testing services comply with applicable regulatory and accreditation requirements, including CLIA, CAP, NY State CLEP, and other relevant regulatory bodies.</span></li> <li style="font-family: 'times new roman', times, serif; font-size: 12pt;"><span style="font-family: 'times new roman', times, serif; font-size: 12pt;">Ensure testing systems, methodologies,

Job Reference ID: CF-169592 • Posted on CloudFrame Job Scanner