Senior Director, Clinical Diagnostics and Precision Medicine
Core
Set global companion diagnostics strategy and drive execution across therapeutic pipelines, integrating diagnostic plans with clinical development, regulatory submission, and launch readiness.
Role type
Senior Director, Companion Diagnostics Strategy
Builds
Global companion diagnostics strategies and assay development plans for therapeutic pipelines
Domain
Biotechnology / Companion Diagnostics / Precision Medicine
Required skills
Companion diagnostics strategy, biomarker hypothesis translation, assay selection and validation, global regulatory strategy (FDA, EU IVDR), external IVD partner management, clinical trial operational readiness, team leadership
Preferred skills
N/A
Technologies
NGS, PCR, immunohistochemistry, immunoassays
Responsibilities
Set and lead global companion diagnostics strategy across the entire pipeline; Translate biomarker biology into diagnostic target product profiles; Define assay selection and development strategy from feasibility through validation; Lead team to develop diagnostic strategies supporting patient selection and evidence generation; Provide executive oversight of external IVD sponsors and partners; Accountable for operational readiness of CDx testing in clinical trials; Shape global CDx regulatory strategy with Regulatory Affairs
Seniority
Senior Director, strategic leadership with hands-on expertise