Distinguished Scientist, Companion Diagnostics
Core
Lead cross-functional Diagnostic Development Teams to drive companion diagnostics (CDx) strategy, development, and implementation for oncology assets and biomarkers.
Role type
Distinguished Scientist / Executive Director, Companion Diagnostics
Builds
Companion diagnostics assays and strategies for oncology therapeutic assets
Domain
Oncology, Companion Diagnostics, Digital Pathology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biomarker development, CDx strategy, regulatory affairs (IVDR, PMDA, HGRAC), clinical trial design, assay platform expertise (NGS, IHC, PCR), team leadership, strategic planning
Preferred skills
Pharma and Dx industry experience, digital pathology expertise, global health authority interfacing
Technologies
NGS, IHC, PCR, Digital Pathology
Responsibilities
Lead cross-functional DxDT including Regulatory, Commercial, and Clinical Development; Supervise PhD-/MD-level employees and coordinate with external Dx partners; Partner with internal stakeholders to assess needs and develop strategies; Contribute to selection of assays, platforms, and Dx partners; Oversee regulatory document preparation and agency meetings; Provide CDx expertise for due diligence and preclinical programs
Seniority
Distinguished Scientist / Executive Director, strategic leadership & mentorship
