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 (CDx)
Builds
Regulatory-grade CDx clinical validation studies for major pharmaceutical partners
Domain
Healthcare / Companion Diagnostics / Clinical Trials
Deliverable
client delivery
Required skills
CDx clinical validation strategy, GCP compliance, clinical study design and execution, biostatistics strategy, project management, cross-functional coordination
Preferred skills
Ph.D. or Masters in relevant discipline, experience in IVD or medical device development
Technologies
None stated
Responsibilities
Lead initial scoping and planning of CDx validation projects and contracts; Develop diagnostic protocols and align 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 management