Director, Research & Development

Essential Responsibilities

• 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.
• 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.
• Prioritize partnerships 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

• 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.