Assay Development Jobs in Boston, MA (NOW HIRING)

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.

CareDx is seeking an accomplished Director of Research & Development to lead the scientific and technical advancement of the NavDx and NavDxGyn product portfolios. This position will provide scientific leadership across assay development, technology innovation, analytical validation, translational research, and future oncology product development.

The Director will be responsible for sustaining and expanding the NavDx platform while advancing next-generation HPV-associated cancer diagnostics, including gynecologic oncology applications and future disease indications. The role requires a scientist with deep expertise in molecular diagnostics, circulating nucleic acids, assay development, translational oncology, and cross-functional leadership.

The successful candidate will operate at the intersection of research, product development, clinical studies, laboratory operations, medical affairs, and regulatory strategy to ensure successful execution of CareDx's specialty oncology growth strategy.

• Lead scientific strategy for NavDx, NavDxGyn, and future HPV-driven cancer products.
• Drive innovation in circulating tumor DNA, viral DNA, fragmentomics, and related molecular diagnostic technologies.
• Identify and evaluate new biomarkers, assay approaches, and product opportunities.
• Develop long-term scientific roadmaps aligned with CareDx specialty oncology strategy.

• Direct analytical development, optimization, and verification of new assays and product enhancements.
• Lead assay transfer activities from research environments into clinical laboratory operations.
• Support design control and product development processes consistent with CareDx quality systems.
• Define technical requirements and development milestones for new oncology products.

• Oversee analytical validation activities supporting laboratory-developed tests.
• Establish experimental designs for sensitivity, specificity, precision, reproducibility, stability, and robustness studies.
• Ensure scientific rigor and documentation suitable for regulatory, reimbursement, and publication purposes.
• Guide implementation of emerging technologies that improve assay performance and scalability.

• Partner with Clinical Affairs and Medical Affairs to design validation studies supporting clinical utility and coverage objectives.
• Support evidence generation for existing and future indications including:
• Contribute to publication strategies, conference presentations, and scientific communications.

• Serve as the R&D lead on cross-functional product teams.
• Collaborate with Laboratory Operations, Quality, Regulatory, Medical Affairs, Market Access, and Commercial teams.
• Support reimbursement initiatives by providing scientific rationale, validation data, and technical expertise.
• Partner with external investigators, key opinion leaders, academic institutions, and collaborators.

• Build and mentor high-performing research scientists and laboratory development teams.
• Establish a culture of scientific excellence, innovation, accountability, and execution.
• Manage departmental budgets, resources, and external research collaborations.
• Recruit and develop scientific talent to support portfolio growth.

• Represent CareDx at scientific meetings, advisory boards, and investigator collaborations.
• Maintain awareness of emerging technologies and competitive developments in oncology liquid biopsy and molecular diagnostics.
• Support intellectual property assessment and invention generation activities.

Required Qualifications

• PhD in Molecular Biology, Cancer Biology, Genetics, Genomics, Biochemistry, or related discipline.

• 10+ years of relevant experience in molecular diagnostics, biotechnology, oncology, or translational research.
• Demonstrated experience leading assay development programs from concept through clinical implementation.
• Experience with circulating nucleic acid technologies including ctDNA, cfDNA, viral DNA, or related biomarker platforms.
• Experience leading multidisciplinary scientific teams.
• Strong record of scientific publications and presentations.

• Molecular diagnostics assay development.
• qPCR, ddPCR, NGS, or advanced genomic technologies.
• Analytical validation methodology.
• Study design and biostatistical interpretation.
• CLIA laboratory environment and LDT development.
• Biomarker discovery and translational research.

• Experience with HPV-related oncology diagnostics.
• Experience supporting reimbursement, MolDx, or payer evidence submissions.
• Experience in oncology liquid biopsy platforms.
• Prior involvement with successful commercialization of diagnostic products.
• Experience managing collaborations with academic medical centers and KOL networks.
• Familiarity with intellectual property development and technology transfer.

Every individual at CareDx has a direct impact on our collective mission to improve the lives of organ transplant patients worldwide. We believe in taking great care of our people, so they take even greater care of our patients.

Our competitive Total Rewards package for US Employees includes:

• Competitive base salary and incentive compensation
• Health and welfare benefits, including a gym reimbursement program

In addition, we have a Living Donor Employee Recovery Policy that allows up to 30 days of paid leave annually to a full-time employee who makes the selfless act of donating an organ or bone marrow.

With products that are making a difference in the lives of transplant patients today and a promising pipeline for the future, it’s an exciting time to be part of the CareDx team. Join us in partnering with transplant patients to transform our future together.

CareDx, Inc. is an Equal Opportunity Employer-vets/disabled, and participates in the E-Verify program.

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.

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

$185,000 - $240,000 USD