Senior Companion Diagnostics Program Lead

Tempus AI, Inc.; Chicago (IL); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Incentive compensation

Restricted stock units

Medical benefits

Job summary

Tempus AI, Inc. is seeking a Senior Manager, Companion Diagnostics to lead planning, oversight, and execution of complex CDx validation studies for pharmaceutical partners. This role bridges drug trial requirements with diagnostic validation to ensure regulatory compliance and timely study completion.

The position requires strong GCP knowledge, biostatistics strategy, and cross-functional collaboration to deliver high-stakes CDx projects and build internal expertise for long-term success.

Qualifications

• PhD or Masters in a relevant discipline preferred, otherwise equivalent experience.
• 5 years in IVD/medical device development with 2+ years in clinical study design.
• Experience with GCP-grade setup, monitoring and reporting and FDA strategies.

Responsibilities

• Lead scoping and planning of CDx validation projects with internal and external stakeholders.
• Develop diagnostic protocols aligned to drug trial strategy and SAPs.
• Collaborate with internal pharma sequencing, QA, CRO, Regulatory, and external consultants.
• Oversee regulatory-grade CDx clinical studies for major partners.
• Ensure compliance with GCP and other regulatory requirements; manage timelines.

Skills

CDx development

Clinical study design

GCP knowledge

Biostatistics strategy

Regulatory compliance

Education

PhD or Master's in a relevant field

Tools

GCP workflows

Job description

Tempus AI, Inc. is seeking a Senior Manager, Companion Diagnostics to lead planning, oversight, and execution of complex CDx validation studies for pharmaceutical partners. This role bridges drug trial requirements with diagnostic validation to ensure regulatory compliance and timely study completion.

The position requires strong GCP knowledge, biostatistics strategy, and cross-functional collaboration to deliver high-stakes CDx projects and build internal expertise for long-term success.