Senior Manager, Companion Diagnostics at Tempus

Compensation

$120,000 – $165,000/yr

Setup: Hybrid
Location: Illinois · California · +2
Type: Full-time
Level: Senior

Description

Tempus is looking for a Senior Manager, Companion Diagnostics (CDx) to lead the planning, oversight, and execution of complex companion diagnostic clinical validation studies for pharmaceutical partners. The role involves bridging the gap between drug trial requirements and diagnostic validation, ensuring regulatory compliance and timely study completion.

Required Skills

clinical study design and execution
GCP-grade study setup, monitoring, and reporting
biostatistics strategy
Statistical Analysis Plans (SAPs)
good clinical practices

Additional Information

Required Previous Experiences: 5 years of demonstrated experience in IVD or medical device development
minimum of 2 years of experience in clinical study design and execution
Preferred Qualifications: Experience with GCP-grade study setup, monitoring, and reporting, including understanding of trial master file documentation and FDA strategies.
Proven ability to understand biostatistics strategy and help craft strategic workplans and Statistical Analysis Plans (SAPs) with support from SMEs (biostatistics, IVD consultants) as needed.
Familiarity with the distinct requirements and complexities of CDx clinical development, including clinical validation strategies and ensuring that studies are conducted and documented in accordance with good clinical practices and other applicable regulatory requirements.
Ability to facilitate clear communication and coordinate resources across internal (Pharma sequencing, QA, CRO, Regulatory, others) and external (IVD consultants, the drug trial sponsor).

About Tempus

Tempus

Precision Medicine & Genomic TestingChicago, IL, United States

Tempus has built the world’s largest library of clinical & molecular data and an operating system to make that data accessible and useful, starting with cancer.

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