Senior Manager, Companion Diagnostics (CDx)
$120,000–$165,000 year
On-siteChicago, Illinois, United States
Job Summary
Lead planning, oversight, and execution of complex Companion Diagnostic (CDx) clinical validation studies for pharmaceutical partners. Drive early scoping and alignment by coordinating input from internal experts, external consultants, and trial sponsors. Develop diagnostic protocols that translate drug trial strategies into clinical Dx validation plans with sound biostatistical approaches. Take ownership of day-to-day management and execution of regulatory-grade CDx studies while ensuring adherence to GCP and regulatory scrutiny. Manage project deliveries to meet agreed-upon timelines and resource requirements. This role bridges drug trial requirements and diagnostic validation to deliver real-time, actionable insights on the right treatments for the right patients.
Required Qualifications
- 5 years of demonstrated experience in IVD or medical device development
- minimum of 2 years of experience in clinical study design and execution
- Experience with GCP-grade study setup, monitoring, and reporting
- understanding of trial master file documentation
- understanding of FDA strategies
- Proven ability to understand biostatistics strategy
- ability to help craft strategic workplans and Statistical Analysis Plans (SAPs)
- Familiarity with the distinct requirements and complexities of CDx clinical development
- ability to ensure that studies are conducted and documented in accordance with good clinical practices
- ability to ensure that studies are documented in accordance with other applicable regulatory requirements
- Ability to facilitate clear communication
- ability to coordinate resources across internal and external stakeholders
Desired Qualifications
- A Ph.D. or Masters in a relevant discipline
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