Senior Director, Research & Development
On-siteChicago, Illinois, United States
Job Summary
Senior Director, Research & Development at Tempus leading late-stage molecular diagnostic product development (IVD, CDx, IUO, and LDT programs). Responsible for design controls, validation planning and execution, design transfer, and post-launch changes; serves as a cross-functional partner to Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, Program Management, and Pharma Business Development. Leads regulatory submission support (FDA, IVDR, MolDX, NYS, CAP, and other global/regional requirements), ensures inspection-ready documentation and scalable development processes, mentors teams, and contributes to resource planning and budgeting to advance Tempus’ regulated diagnostics portfolio. Qualifications include experience in regulated diagnostic development, strong leadership, and proven ability to drive complex technical and regulatory milestones.
Required 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
- Experience 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
- Strong people management experience
- Experience supporting audits, inspections, pre-submissions, deficiency responses, and approval pathways
- Experience with companion diagnostics developments, pharma partnerships, and external development programs
- Experience with automation, LIMS, and 21 CFR Part 11 compliant software tools such as ELNs
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