Backed by NEA.
About the role
This role is critical to advancing Tempus’ regulated diagnostics portfolio by ensuring products are scientifically robust, operationally scalable, and developed with the rigor required for successful launch, regulatory approval, and long-term platform growth.
What they're looking for
- PhD with 8+ years of experience or Master’s degree with 13+ years of experience in molecular diagnostics, assay development, or a related life sciences field in a regulated environment
- Deep experience leading design-controlled product development for molecular diagnostics or sequencing-based assays
- Strong working knowledge of IVD/CDx development, validation, design transfer, and regulatory submissions
- Demonstrated success working in regulated frameworks including FDA, IVDR, ISO 13485, QMSR, MolDX, and NYS
- Track record of leading cross-functional teams through complex technical and regulatory milestones
- Experience building scalable processes, documentation systems, and development infrastructure in a fast-paced environment
More about this role
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Passionate about advancing precision diagnostics and regulated assay development?
Tempus is seeking a Senior Director, Research & Development to lead late-stage assay and product development across molecular diagnostics, with a focus on design-controlled IVDs, CDx, IUOs, LDTs, assay transfer, and process excellence. This leader will drive complex development programs from concept through launch, partner across R&D and operational functions, and build scalable systems that enable high-quality, inspection-ready product development.
- Lead late-stage development, validation, and launch readiness for molecular diagnostic products, including IVD, CDx, IUO, and LDT programs
- Provide strategic and scientific leadership for design controls, validation...
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