Director CDx Development

Role: Companion Diagnostics (CDx) Lead responsible for defining and executing integrated diagnostic strategies aligned with clinical development programs to enable precision medicine. Responsibilities: lead development of biomarker and assay strategies, collaborate with research, regulatory, and external partners, define diagnostic target profiles, support regulatory submissions (e.g., IDEs, PMAs), oversee CDx development timelines, and monitor industry/trends. Requirements: PhD with 5+ years in clinical biomarker testing, companion diagnostics, and successful drug or IVD approvals; expertise in platforms like NGS, IHC, FISH; strong leadership and cross-functional collaboration skills; strategic thinker with excellent communication. HighValue: focus on biomarker-driven precision oncology, biomarker/diagnostic development, regulatory approval, IVD technologies, early to late-stage clinical programs, cross-functional stakeholder engagement. WorkSetup: not specified; travel not required.