Medical Laboratory Director

The posting, as CareDx, Inc. wrote it

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

[…]
re 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 and 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

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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