- Chicago, Illinois, United States
- Full-time · Manager
- $120K–$165K per year
- 5+ years
Lead the planning, oversight, and execution of complex Companion Diagnostic (CDx) clinical validation studies for pharmaceutical partners, bridging the gap between drug trial requirements and diagnostic validation.
Compensation
$120,000-$165,000. The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience.
Responsibilities
- Lead the initial scoping and planning of CDx validation projects and contracts.
- Lead the development of diagnostic protocols, translating drug trial strategy into clinical Dx validation strategy.
- Work in partnership with Tempus Pharma sequencing, QA, CRO, and Regulatory, external IVD consultants, and the drug trial sponsor.
- Take ownership of the day-to-day management and execution of regulatory-grade CDx clinical studies.
- Ensure all clinical validation activities meet the requirements for running clinical device studies, including adherence to GCP.
Requirements
- Ph.D. or Masters in a relevant discipline
- Nice to have: Statistical Analysis Plans (SAPs)