Job Details

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 approvalsRepresent Diagnostics on compound development teams and coordinate stakeholder alignment for programs requiring predictive biomarkersDevelop and execute integrated CDx plans to support patient selection, stratification, and therapy assessmentQualifications and Experience:PhD in a biological science with at least 7 years of industry experience in biomarker assays integration into clinical trialsExperience in oncology and immuno-oncology drug development, particularly in driving biomarker-driven patient selection strategiesWorking knowledge of CDx development processes, including analytical/clinical validation strategies and regulatory interactionsScientific expertise in established and novel CDx assay technologiesExperience authoring biomarker sections in clinical protocols and regulatory documentation