Tempus
Senior Director, Research & Development
$192K–$264K
Chicago · Director · Full-time · Posted Oct 20, 2026
- Experience
- PhD with 8+ years or Master’s degree with 13+ years of relevant experience.
- Education
- PhD or Master’s degree.
About the job
Leads late-stage development, validation, and launch readiness for regulated molecular diagnostic products, building scalable processes and coordinating cross-functional teams.
What you'll do
- Direct assay and product development from concept through launch, including design controls, validation, design transfer, and post-launch changes.
- Coordinate regulatory submission support and cross-functional work with Regulatory, Quality, Clinical Lab Operations, Bioinformatics, and other teams.
- Build inspection-ready development systems, resolve complex issues, improve processes, and lead and develop R&D teams.
What they ask for
- 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 leading cross-functional teams and managing people.
Nice to have
- Experience supporting audits, inspections, pre-submissions, deficiency responses, and approval pathways.
- Experience with companion diagnostics, pharma partnerships, external development programs, automation, LIMS, or 21 CFR Part 11 compliant software tools such as ELNs.
Pay
$192,000-$264,000 USD base salary
Tools
FDA, IVDR, ISO 13485, QMSR, MolDX, NYS, LIMS, ELNs
Model-written summary · the original posting is authoritative