Tempus
$173k – $245k
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 & Development
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.
What You’ll Do
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 planning and execution, design transfer, and post-launch changes
Serve 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 requirements
Oversee documentation strategy and development processes to ensure inspection readiness, consistency, traceability, and scalability
Lead complex issue resolution, including deficiency responses, non-conformances, root cause investigations, and scope pivots
Advance continuous improvement initiatives across product development, including templates, risk-based tools, project estimation, change management, and process standardization
Support external and partner-facing development programs, including companion diagnostics and contractual assay development efforts
Mentor and develop a high-performing teams of scientists and documentation specialists
Contribute to resource planning, budgeting, staffing strategy, and organizational development within R&D
Qualifications
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
Strong leadership, communication, and organizational skills, with the ability to influence across technical and operational stakeholders
Strong people management experience, including hiring, mentoring, and leading teams through growth and change
Highly Desirable
Experience supporting audits, inspections, pre-submissions, deficiency responses, and approval pathways
Experience with companion diagnostic developments, pharma partnerships, and external development programs
Experience with automation, LIMS, and 21 CFR Part 11 compliant software tools such as ELNs
Impact in This 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.
$173,000-$245,000
The 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.