Senior Manager, Clinical Diagnostics CDx (Precision Medicine)
Core
Lead end-to-end Clinical Diagnostics (CDx) strategy and execution to enable therapeutics across indications, translating scientific needs into fit-for-purpose assays for global decisions.
Role type
Senior Manager, Clinical Diagnostics (Precision Medicine)
Builds
CDx assays and diagnostic platforms aligned with drug development milestones
Domain
Precision Medicine / Clinical Diagnostics / In Vitro Diagnostics (IVD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDx strategy execution, cross-functional team leadership, IVD partner management, assay definition and validation (analytical/clinical), global regulatory submission management, quality system compliance (ISO/CLSI/GxP), manufacturing readiness oversight
Preferred skills
Strategic thinking, stakeholder management, executive communication
Technologies
NGS, PCR, IHC, Immunoassays
Responsibilities
Execute end-to-end CDx strategy aligning with therapeutic clinical development; Lead cross-functional teams and integrate workstreams; Manage IVD partners including negotiation and performance oversight; Define assay intent and drive validation linking performance to benefit–risk; Embed CDx assays in trials for screening and lab operations; Partner with regulatory teams on global submissions (FDA, EU, PMDA); Ensure compliance with quality standards and maintain audit readiness; Oversee design transfer and supply chain readiness
Seniority
Senior, hands-on leadership and cross-functional orchestration
