Associate Director, Companion Diagnostics
Behavioral Health Market Context
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Job Description
Dx plans to support patient selection, stratification, and therapy assessment
Qualifications and Experience :
PhD in a biological science with at least 7 years of industry experience in biomarker assays integration into clinical trials
Experience in oncology and immuno-oncology drug development, particularly in driving biomarker-driven patient selection strategies
Working knowledge of CDx development processes, including analytical / clinical validation strategies and regulatory interactions
Scientific expertise in established and novel CDx assay technologies
Experience authoring biomarker sections in clinical protocols and regulatory documentation
Qualifications and Experience :
PhD in a biological science with at least 7 years of industry experience in biomarker assays integration into clinical trials
Experience in oncology and immuno-oncology drug development, particularly in driving biomarker-driven patient selection strategies
Working knowledge of CDx development processes, including analytical / clinical validation strategies and regulatory interactions
Scientific expertise in established and novel CDx assay technologies
Experience authoring biomarker sections in clinical protocols and regulatory documentation
Qualifications
- •PhD in a biological science with at least 7 years of industry experience in biomarker assays integration into clinical trials
- •Experience in oncology and immuno-oncology drug development, particularly in driving biomarker-driven patient selection strategies
- •Working knowledge of CDx development processes, including analytical / clinical validation strategies and regulatory interactions
- •Scientific expertise in established and novel CDx assay technologies
- •Experience authoring biomarker sections in clinical protocols and regulatory documentation
Benefits
Responsibilities
- •Lead CDx strategy for oncology programs from early development through late-stage clinical trials and global Health Authority approvals
- •Represent Diagnostics on compound development teams and coordinate stakeholder alignment for programs requiring predictive biomarkers
- •Develop and execute integrated CDx plans to support patient selection, stratification, and therapy assessment
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