Senior Manager, Precision Medicine - Clinical Diagnostics
Core
Lead end-to-end companion diagnostics (CDx) strategy and execution, translating scientific needs into fit-for-purpose assays for global therapeutic decisions.
Role type
Senior Manager, Clinical Diagnostics
Builds
Companion diagnostics platforms (NGS, PCR, IHC, Immunoassays) aligned with drug development and regulatory timelines
Domain
Precision Medicine / Clinical Diagnostics / Pharma
Required skills
CDx/IVD program leadership, assay development (NGS, PCR, IHC, Immunoassays), global regulatory strategy (FDA, EU IVDR, PMDA), quality systems (ISO 13485/14971, CLSI, GCP), cross-functional team management, IVD partner negotiation
Preferred skills
Experience with biomarker integration, trial design for diagnostics, stakeholder management
Technologies
NGS, PCR, IHC, Immunoassays, ISO 13485, IVDR, FDA CDRH
Responsibilities
Execute end-to-end CDx strategy aligning with clinical development; Lead cross-functional teams and clear obstacles; Manage IVD partners and co-development; Define assay intent and target product profiles; Embed CDx assays in clinical trials; Partner on global regulatory submissions; Ensure compliance with quality and regulatory frameworks
Seniority
Senior, hands-on IC with leadership responsibilities