Tempus
Senior Manager, Companion Diagnostics (CDx)
$120K–$165K
Chicago · Manager · Full-time · Posted Oct 20, 2026
- Experience
- 5 years in IVD or medical device development, with a minimum of 2 years in clinical study design and execution.
- Education
- Ph.D. or Master’s in a relevant discipline is highly preferred; equivalent professional experience will be considered.
About the job
Leads planning and execution of clinical validation studies for companion diagnostics, ensuring regulatory compliance and timely delivery for pharmaceutical partners.
What you'll do
- Scope projects and develop diagnostic protocols and validation strategies.
- Oversee day-to-day execution of regulatory-grade CDx clinical studies and coordinate internal and external stakeholders.
- Ensure GCP and regulatory compliance, manage resources, and deliver studies on schedule.
What they ask for
- 5 years of experience in IVD or medical device development, including at least 2 years in clinical study design and execution.
- Experience with GCP-grade study setup, monitoring, and reporting, including trial master file documentation and FDA strategies.
- Ability to develop biostatistics-informed workplans and Statistical Analysis Plans with subject-matter experts.
- Familiarity with CDx clinical development, validation strategies, and applicable good clinical practice and regulatory requirements.
Nice to have
- Ph.D. or Master’s in a relevant discipline; equivalent professional experience will be considered.
Pay
$120,000-$165,000 (base salary)
Tools
GCP, FDA, Statistical Analysis Plans (SAPs)
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