Director, Research & Development

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. 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. • Es…