Tempus AI
Senior Director, Research & Development
Chicago · Director
Sponsorship not specified$230k-$260kDetected 21 days ago
Business DevelopmentBudgetingPatient CareFDA RegulatoryBioinformaticsMedical DevicesResearchLeadershipCommunicationMentoringOrganizational Skills
About the role
- Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way.
- Senior Director, Research & Development Passionate about advancing precision diagnostics and regulated assay development?
- Actual salary may vary based on qualifications and experience.
Responsibilities
- 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
- Lead complex issue resolution, including deficiency responses, non-conformances, root cause investigations, and scope pivots
- 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
- 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
- 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.
Requirements
- 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
- Track record of leading cross-functional teams through complex technical and regulatory milestones
- Strong leadership, communication, and organizational skills, with the ability to influence across technical and operational stakeholders
- 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
Compensation
- The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York).
Benefits
- Passionate about precision medicine and advancing the healthcare industry?
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