Senior Director, Regulated Diagnostics & Precision Medicine

Tempus AI; Illinois; On-site; USD 173,000 - 245,000; Full time

Benefits offered by this job

Incentive compensation

Restricted stock units

Medical benefits

Competitive benefits

Job summary

Tempus is seeking a Senior Director, Research & Development to lead late-stage molecular diagnostic programs, including IVD, CDx, IUO, and LDT initiatives, with emphasis on design controls and process excellence.

This leader will collaborate across Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, Program Management, and Pharma Business Development to ensure regulatory submissions, inspection readiness, and scalable development systems.

Qualifications

• PhD or Master’s with extensive life sciences experience in regulated environments.
• Deep experience leading design-controlled product development for molecular diagnostics or sequencing-based assays.
• Strong knowledge of FDA, IVDR, ISO 13485, QMSR, MolDX, and NYS regulatory submissions.

Responsibilities

• Lead late-stage development, validation, and launch readiness for molecular diagnostic products (IVD, CDx, IUO, LDT).
• Provide strategic leadership for design controls, validation planning and execution, design transfer, and post-launch changes.
• Serve as a cross-functional partner to Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, and Program Management.

Skills

Cross-functional leadership

Regulatory submissions

People management

Project management

Strategic leadership

Communication

Education

PhD in molecular diagnostics

Master's in life sciences

Tools

LIMS

ELNs

Job description

Tempus is seeking a Senior Director, Research & Development to lead late-stage molecular diagnostic programs, including IVD, CDx, IUO, and LDT initiatives, with emphasis on design controls and process excellence.

This leader will collaborate across Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, Program Management, and Pharma Business Development to ensure regulatory submissions, inspection readiness, and scalable development systems.