Jobs › Tempus AI

Senior Director, Research & Development

Tempus AI · Chicago, IL · $192,000–$264,000 a year · Full time

Posted Sep 24, 2026 · We last checked this listing on Oct 6, 2026

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Likely interview questions for this role

Written from this job description, not a generic list. Each one notes what the interviewer is really checking.

About your past

Walk me through a molecular diagnostic you took from late-stage development through launch under design controls.

What they are checking: Direct leadership of design-controlled IVD or CDx programs, not only early research.

Tell me about an assay transfer from R&D to operations that went poorly. What did you change?

What they are checking: Practical lessons about design transfer, which is a common failure point.

How do you develop and lead a team of senior scientists and managers?

What they are checking: Leadership at director level, including coaching leaders rather than doing their work.

Tell me about a time you had to push back on a launch date for quality reasons.

What they are checking: Integrity and the courage to protect patients and inspection readiness under business pressure.

What would you do

Regulatory, Quality and Clinical disagree on a validation approach and the timeline is at risk. What do you do?

What they are checking: Ability to lead cross-functional partners to a decision without losing compliance.

How would you build systems that make product development scalable and repeatable here?

What they are checking: Process excellence thinking that goes beyond running one program at a time.

About the work

How do the paths differ for an IVD, a CDx, an IUO and an LDT, and how does that change your development plan?

What they are checking: Clear understanding of regulatory categories and how they shape validation and timelines.

How do you plan an analytical validation so it is inspection-ready from day one?

What they are checking: Whether their validation planning, documentation and traceability would hold up to an inspector on any given day.

A post-launch change is needed to a cleared assay. How do you decide what testing and filings it requires?

What they are checking: Judgment about change control and regulatory impact after launch.

How do you manage risk across a portfolio of development programs?

What they are checking: Whether they can see risk, resources and timing across many programs at once, not one at a time.

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The full job description

As published by Tempus AI.

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. Pay Range: $192,000-$264,000 The expected salary range may vary for other locations. 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.

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