Senior Manager, Companion Diagnostics (CDx)
Core
Lead planning, oversight, and execution of complex Companion Diagnostic (CDx) clinical validation studies for pharmaceutical partners.
Role type
Senior Manager, Companion Diagnostics
Builds
Regulatory-grade CDx clinical validation studies for major pharmaceutical partners
Domain
Healthcare / Companion Diagnostics / Clinical Validation
Deliverable
production ML models
Required skills
IVD or medical device development, clinical study design and execution, GCP compliance, biostatistics strategy, project management, cross-functional collaboration
Preferred skills
Ph.D. or Masters in relevant discipline, FDA strategies, trial master file documentation
Technologies
None stated
Responsibilities
Lead initial scoping and planning of CDx validation projects and contracts; Develop diagnostic protocols and align on clinical data generation & analysis plans; Provide oversight for internal and external validation work; Manage day-to-day execution of regulatory-grade CDx clinical studies; Ensure adherence to GCP and regulatory requirements; Manage project deliveries and resourcing
Seniority
Senior, hands-on IC with management responsibilities
