Senior Director, Research & Development (Chicago)

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.Senior Director, Research & DevelopmentPassionate 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.What You’ll DoLead late-stage development, validation, and launch readiness for molecular diagnostic products, including IVD, CDx, IUO, and LDT programsProvide strategic and scientific leadership for design controls, validation planning and execution, design transfer, and post-launch changesServe as a key cross-functional partner to Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, Program Management, and Pharma Business Development Drive regulatory submission support, including FDA, IVDR, MolDX, NYS, CAP, and other global or regional requirementsOversee documentation strategy and development processes to ensure inspection readiness, consistency, traceability, and scalabilityLead complex issue resolution, including deficiency responses, non-conformances, root cause investigations, and scope pivotsAdvance continuous improvement initiatives across product development, including templates, risk-based tools, project estimation, change management, and process standardizationSupport external and partner-facing development programs, including companion diagnostics and contractual assay development effortsMentor and develop a high-performing teams of scientists and documentation specialistsContribute to resource planning, budgeting, staffing strategy, and organizational development within R&DQualificationsPhD 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 environmentDeep experience leading design-controlled product development for molecular diagnostics or sequencing-based assaysStrong working knowledge of IVD/CDx development, validation, design transfer, and regulatory submissionsDemonstrated success working in regulated frameworks including FDA, IVDR, ISO 13485, QMSR, MolDX, and NYSTrack record of leading cross-functional teams through complex technical and regulatory milestonesExperience building scalable processes, documentation systems, and development infrastructure in a fast-paced environmentStrong leadership, communication, and organizational skills, with the ability to influence across technical and operational stakeholdersStrong people management experience, including hiring, mentoring, and leading teams through growth and changeHighly DesirableExperience supporting audits, inspections, pre-submissions, deficiency responses, and approval pathwaysExperience with companion diagnostic developments, pharma partnerships, and external development programsExperience with automation, LIMS, and 21 CFR Part 11 compliant software tools such as ELNsImpact in This RoleThis 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.$173,000-$245,000The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. SummaryLocation: ChicagoType: Full time