--- title: 'Medical Laboratory Director at CareDx, Inc.' canonical: 'https://feeny.ai/job/medical-laboratory-director-caredx-inc-waltham-58vww2r7qykb' type: 'job' last_seen: '2026-09-15' --- # Medical Laboratory Director at CareDx, Inc. - **Company:** CareDx, Inc. - **Location:** Waltham, MA - **Compensation:** $142k–$185k - **Posted:** 2026-07-29 - **Last confirmed live:** 2026-09-15 - **Apply:** https://job-boards.greenhouse.io/caredxinc/jobs/4330347009 ## Job description 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 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% Minimum Education, Experience, & Specialized Knowledge (Required): Education and Certifications - 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 ## 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. CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program. By proceeding with our application and submitting your information, you acknowledge that you have read our [U.S. Personnel Privacy Notice](https://nam04.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.caredx.com%2Fus-personnel-privacy-notice&data=05%7C02%7C%7C7909ec363e2b416b016a08de7886b61c%7C9ec77d4e480144b4b8fea5749eaf06b0%7C1%7C0%7C639080717137822026%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=rz649lSGHm5Ca8UOMhbSARMbRhbyMFHdOgEEBXImKs4%3D&reserved=0)https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fcaredx.com%2Fus-personnel-privacy-notice%2F&data=05%7C02%7C%7C82daf31a87e44746b2ea08dceef5e348%7C9ec77d4e480144b4b8fea5749eaf06b0%7C1%7C0%7C638647987067924758%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=fvNqQdyyA0YaWb3Y4bxHjbbzsxfJ4EmKAEMFQr39KnU%3D&reserved=0and consent to receive email communication from CareDx. Certain jurisdictions require notice of how we use and protect your personal information. For more information, please read our [Privacy Policy](https://caredx.com/privacy-center/#ca-privacy) The U.S. EEO posters are available [here](http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf). Note: We do not accept resumes from headhunters, placement agencies, or other suppliers that have not signed a formal agreement with us. This is the anticipated base salary range for candidates who will work in Waltham, MA. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience within the job, the type and length of experience within the industry, education, etc. Base pay is one part of the Total Package that is provided to compensate and recognize employees for their work, and this role may be eligible for additional discretionary bonuses/incentives and restricted stock units. CareDx is a multi-state employer, and this salary range may not reflect positions that work in other states. United States $142,000—$185,000 USD ## About CareDx, Inc. ## Company Overview - **One-liner**: CareDx is a precision medicine company providing molecular diagnostics, workflow software, patient support, and pharmacy services for transplant patients and, following the acquisition of Naveris, for specialty oncology. - **Entity Type**: Public (NASDAQ: CDNA) - **Headquarters**: Brisbane, California, USA (with a co-headquarters in Stockholm, Sweden) - **Founded**: 2000 - **Founders**: Not publicly available ## Core Business - **Primary industry/industries**: Transplant diagnostics, precision medicine, molecular testing, healthcare IT, specialty oncology - **Target customers**: B2B (transplant centers, clinicians, hospitals) and B2C (transplant patients and caregivers) - **Mission**: Create life-changing solutions that enable transplant patients to thrive. - **Vision**: A world where every patient receives the transplant they need to live longer, fuller lives. ## Products & Services - **AlloSure® / AlloMap® / HeartCare® / KidneyCare® / LiverCare®**: Non-invasive molecular monitoring tests (donor-derived cell-free DNA and gene expression profiling) to detect organ rejection earlier in heart, kidney, and liver transplant recipients. (Type: Diagnostic test) - **CareDx Transplant Pharmacy**: Full-service pharmacy that fills over 150,000 prescriptions annually, providing immunosuppressant and supportive medications. (Type: Service) - **CareDx Software Suite (e.g., XynManagement, CareDx Connect)**: Workflow tools used by 70% of US transplant centers to manage patient data, lab results, and care coordination. (Type: SaaS) - **Naveris (acquired July 2026)**: Extends CareDx’s portfolio into high-growth specialty oncology, focusing on circulating tumor DNA (ctDNA) monitoring. (Type: Diagnostic test / Service) ## Market Standing - **Valuation/Market Cap**: ~$2.5 billion (as of early July 2026) [investors.caredx.com](https://investors.caredx.com/) - **Key Metric (Annual Revenue)**: $379.8 million (most recent fiscal year) [linkedin.com](https://www.linkedin.com/company/care-dx-inc) - **Notable Investors/Partners**: Bristol‑Myers Squibb (Series G lead), Sprout Group (Series D lead); partnerships with over 180 commercial employees supporting transplant centers. - **Growth Signals**: Completed acquisition of Naveris (July 2026) to enter oncology – a high‑growth adjacent market. Completed sale of its Lab Products business to Eurobio Scientific (June 2026) to sharpen focus on diagnostics and digital health. Over 30 abstracts and 9 oral presentations at the 2026 American Transplant Congress. Performed its one‑millionth rejection‑monitoring test. ## Competitive Advantages - **Market leadership** in transplant diagnostics, serving the vast majority of US transplant centers. - **Integrated end‑to‑end platform** – from molecular tests and pharmacy to software and patient support – that creates stickiness and deep integration into clinical workflows. - **Large, real‑world evidence database** from millions of test results, enabling continuous improvement of algorithms and clinical evidence. - **High barriers to entry**: regulatory clearance (CMS coverage, FDA clearance for certain tests) and long‑standing relationships with transplant centers. ## Strategic Focus - **Expansion beyond transplant** into specialty oncology via the Naveris acquisition, leveraging existing commercial and diagnostic infrastructure. - **Deepening digital health and software capabilities** to further integrate with hospital systems and improve patient outcomes. - **Maximizing value of the transplant franchise** through innovation in molecular monitoring (e.g., new indications, multi‑organ panels) and pharmacy adherence programs. ## Why Work Here - **Mission‑driven culture**: Employees directly contribute to helping transplant patients live longer, fuller lives. - **Values**: Respect One Another, Decide with Data, Take Accountability, Evangelize Your Work – emphasizing transparency, data‑driven decisions, and ownership. - **Benefits**: Competitive medical/dental/vision plans, 401(k) with employer match, Employee Stock Purchase Plan (ESPP), Health Savings Account (HSA), flexible spending accounts, paid time off, living‑donor recovery policy, on‑site gym (Brisbane office). - **Work environment**: Collaborative, purpose‑driven, with opportunities for growth across diagnostics, biotech, and digital health. Remote/hybrid policy not publicly specified; likely varies by role. ## Sources 1. [caredx.com](https://caredx.com/) – Company overview and product information 2. [caredx.com/company](https://caredx.com/company/) – Mission, leadership, employee count, values 3. [caredx.com/careers](https://www.caredx.com/careers) – Benefits and culture details 4. [investors.caredx.com](https://investors.caredx.com/) – Market cap, recent acquisitions, SEC filings 5. [linkedin.com](https://www.linkedin.com/company/care-dx-inc) – Revenue, employee count, funding history, stock details ## Other roles at CareDx, Inc. - [Staff Scientist](https://feeny.ai/job/staff-scientist-caredx-inc-brisbane-f760y58ffwm8) — Brisbane, CA - [Medical Director Oncology](https://feeny.ai/job/medical-director-oncology-caredx-inc-united-states-brdec8mdb6p5) — United States - [Lead Finance Systems Administrator](https://feeny.ai/job/lead-finance-systems-administrator-caredx-inc-remote-6mx7v1yapb83) - [Clinical Lab Aide II](https://feeny.ai/job/clinical-lab-aide-ii-caredx-inc-brisbane-j473ce82gf5s) — Brisbane, CA - [Research Associate – Molecular Assay Development (Digital PCR)](https://feeny.ai/job/research-associate-molecular-assay-development-digital-pcr-caredx-inc-waltham-v0ewmcc1n2b6) — Waltham, MA - [Insurance Reimbursement Specialist](https://feeny.ai/job/insurance-reimbursement-specialist-caredx-inc-brisbane-byd2tm0v4tz9) — Brisbane, CA - [Senior Biostatistician](https://feeny.ai/job/senior-biostatistician-caredx-inc-brisbane-1nrnj2fxfadj) — Brisbane, CA - [Vice President of Specialty Oncology, Franchise Leader](https://feeny.ai/job/vice-president-of-specialty-oncology-franchise-leader-caredx-inc-brisbane-wtzyppeq47zt) — Brisbane, CA - [Sr. Manager, Accounts Payable](https://feeny.ai/job/sr-manager-accounts-payable-caredx-inc-united-states-2nysesx99qv2) — United States - [Lung Transplant Account Manager](https://feeny.ai/job/lung-transplant-account-manager-caredx-inc-remote-pg767rcpfj61)