Associate Director, Clinical Diagnostics
Core
Lead end-to-end strategy, development, and lifecycle management of companion diagnostic solutions (CDx) to enable therapeutics, ensuring alignment with drug development milestones.
Role type
Associate Director, Clinical Diagnostics
Builds
Companion diagnostic assays and platforms (NGS, PCR, IHC, Immunoassays) for therapeutic programs
Domain
Biopharmaceuticals / Clinical Diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDx strategy, IVD partner management, assay intent definition, analytical validation, clinical validation, regulatory submissions, cross-functional program leadership
Preferred skills
Deep understanding of diagnostic platforms, experience with global regulatory standards (FDA, EU IVDR)
Technologies
NGS, PCR, IHC, Immunoassays
Responsibilities
Set global CDx strategy aligning with clinical/regulatory timelines; Lead selection and oversight of IVD partners; Define assay intent and target product profiles; Partner with biomarker/clinical teams to integrate CDx into trial designs; Drive analytical and clinical validation plans; Support global regulatory strategy and submissions; Coordinate cross-functional working groups; Oversee design transfer and manufacturing readiness
Seniority
Senior, hands-on IC with strategic oversight
