Associate Director, Companion Diagnostics

Job Summary

A company is looking for an Associate Director, Companion Diagnostics.

Key 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

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