- Interim or fractional biomarker lead for preclinical through Phase 3 oncology programs - Development of biomarker strategies grounded in mechanism of action (MOA), mechanism of resistance (MOR) and clinical hypotheses - Authoring biomarker sections for protocols, INDs, and study reports
- Assay and CRO/vendor oversight, including validation, QC, and milestone tracking - Translational interpretation of biomarker data to support dose selection and patient stratification - Cross-functional representation on study teams, advisory boards, and regulatory discussions
- IND and BLA biomarker submission packages - Data visualization and interpretation for internal reviews and investor communications - Expert insights on biomarker risk mitigation and regulatory compliance