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.
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.
Essential Responsibilities
Scientific Leadership
• 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.
Product Development
• 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.
Analytical Validation
• 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.
Clinical Evidence Generation
• 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.
Cross-Functional Leadership
• 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.
Team Leadership
• 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.
External Scientific Engagement
• 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
Education
• PhD in Molecular Biology, Cancer Biology, Genetics, Genomics, Biochemistry, or related discipline.
Experience
• 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.
Technical Expertise
• 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.
Preferred Qualifications
• 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.
Additional Details:
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
- 401(k) savings plan match
- Employee Stock Purchase Plan
- Pre-tax commuter benefits
- And more!
- Please refer to our page to view detailed benefits at https://caredx.com/company/careers
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. 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
The U.S. EEO posters are available here.
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.
Skills Required
- PhD in Molecular Biology, Cancer Biology, Genetics, Genomics, Biochemistry, or related discipline
- 10+ years 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 (ctDNA, cfDNA, viral DNA)
- Experience leading multidisciplinary scientific teams
- Strong record of scientific publications and presentations
- Molecular diagnostics assay development expertise
- Technical experience with qPCR, ddPCR, NGS or advanced genomic technologies
- Analytical validation methodology experience
- Study design and biostatistical interpretation skills
- Experience in CLIA laboratory environment and LDT development
- Biomarker discovery and translational research experience
- Experience with HPV-related oncology diagnostics
- Experience supporting reimbursement, MolDx, or payer evidence submissions
- Experience in oncology liquid biopsy platforms and commercialization of diagnostic products
- Experience managing collaborations with academic medical centers and KOL networks
- Familiarity with intellectual property development and technology transfer
What We Do
CareDx: Transforming Transplant Patient Care Through Novel Surveillance Management Solutions CareDx, Inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. By combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, CareDx is at the forefront of organ transplant surveillance and pre-transplant HLA typing solutions. NASDAQ:CDNA About AlloSure® AlloSure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. AlloSure is a clinical-grade, proprietary Next-Generation Sequencing (NGS) based test to detect donor-derived cell-free DNA (dd-cfDNA) in order to identify organ injury in kidney transplant recipients. AlloSure is analytically validated as a sensitive, specific, and precise measurement of dd-cfDNA. AlloSure detects active rejection (acute active ABMR, chronic active ABMR, or TCMR) with high accuracy, outperforms serum creatinine in kidney transplant recipients, and is highly sensitive in distinguishing ABMR from no ABMR. AlloSure is performed in the CareDx CLIA-certified laboratory. http://www.allosure.com/ About AlloMap® AlloMap Molecular Expression Testing is a non-invasive blood test used to aid in the identification of heart transplant recipients with stable allograft function who have a low probability of moderate/severe acute cellular rejection at the time of testing in conjunction with standard clinical assessment. AlloMap testing measures the expression levels of 20 genes from a blood sample. The combined expression of these genes is represented as an AlloMap test score. AlloMap is performed in the CareDx CLIA-certified laboratory and has been commercially available in the United States since 2005. AlloMap was cleared by the U.S. Food and Drug Administration in 2008 and was CE marked for the European Union in 2011. Use of AlloMap is also included in the International Society for Heart and Lung Transplantation (ISHLT) Practice Guidelines, published in August 2010, the worldwide standard for the care of heart transplant patients. http://www.allomap.com/
