Sr. Director, R&D - Product Development

CareDx, Inc.•Brisbane, CA

7d•$215,000 - $280,000

About The Position

CareDx, Inc. is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers products, testing services, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. CareDx is seeking an experienced scientific leader to guide product development efforts across product development and the optimization and enhancement of existing transplant diagnostic solutions implemented in CareDx’s CLIA laboratory. This role will oversee cross-functional R&D teams to drive product innovation and improvements, sustain high performance, and extend the clinical and market impact of CareDx’s portfolio. Key areas of responsibility include product development, product improvements, troubleshooting, integration of user feedback, and operational scalability, in close partnership with Product Life Cycle and Operations teams. The ideal candidate brings deep scientific expertise and a enthusiasm for finding creative, resourceful solutions within the real-world constraints of complex diagnostic operations.

Requirements

PhD in molecular biology, immunology, bioengineering, chemistry, or related field.
15+ years developing diagnostic assays, with at least 5 years in leadership roles.
In-depth understanding of molecular biology techniques and DNA / RNA extractions. Experience with cfDNA and NGS sequencing is a must.
Knowledge of applicable regulations such as, CLIA / CAP, CLEP and FDA, ISO 13485. Solid understanding of good product development practices and experience with complex diagnostic assay development is required; system integration experience preferred.
Demonstrated experience managing and developing high-performing scientific or technical teams.
Proven ability to lead cross-functional initiatives and drive alignment across diverse stakeholders.
Strong interpersonal and communication skills with the ability to influence at all levels of the organization.
Mature leadership presence with a strategic mindset and a collaborative approach to problem-solving.

Responsibilities

Provide strategic and operational leadership to a Research & Development team focused on product development, product improvements and optimizations. Participate in strategic and tactical planning to ensure desired product performance, reliability, and market relevance. Scale and develop the team in alignment with evolving business and product priorities.
Develop in-depth understanding of transplant market and our existing products including detailed knowledge of assay design, system integration, and clinical laboratory workflows in a CLIA-certified environment.
Drive execution of product development initiatives in collaboration with R&D, PMO, Data/AI, Clinical, Regulatory, Quality, Operations, and Commercial teams.
Oversee design and development strategies, validation plans, and product transfer activities. Drive risk-informed efficiency, ensure stakeholder alignment prior to execution, and oversee delivery in compliance with internal procedures and applicable regulations. Monitor project milestones and conduct regular progress and design reviews.
Partner with Clinical and Product Life Cycle teams to assess user feedback and market trends, and with Operations to understand workflow needs. In collaboration, define and maintain a long-term product development and improvement roadmap supported by research collaborations, product enhancements, and new product versions
Partner with PMO and Operations to continuously improve product development, product improvement, and operations support processes, focused on cross-functional collaboration, execution transparency, and operational efficiency.
Promote R&D efforts and ensure effective communication and alignment with senior leadership and across CareDx departments.
Contribute to R&D team management, including budget management, staffing and capacity planning, process improvements, space planning, and mentoring and developing scientific and technical staff to foster a high-performing and collaborative team culture.
Establish clear goals, performance expectations, and development plans for team members.
Stay informed about emerging research, market trends, and innovations to ensure existing products remain competitive and effective.
Contribute substantially to the development of CareDx's intellectual property portfolio.