Biomarker Operations Lead

Job description

Position Overview Excelya is seeking a highly motivated and experienced Biomarker Operations Lead to oversee and manage biomarker activities across clinical study phases. This role involves coordinating with internal teams and external partners to ensure efficient execution of biomarker strategies and operational excellence. The Biomarker Operations Lead will provide operational biomarker expertise to ensure successful implementation and execution of the biomarker strategy across Phase I–III clinical studies . The role supports timely, high‑quality delivery of clinical biomarkers in compliance with ICH/GCP and applicable regulations. Key Responsibilities: - Execute the biomarker and companion diagnostic strategy for assigned studies - Plan, coordinate and oversee all operational activities related to the biomarker sample lifecycle - Support selection and management of biomarker vendors in collaboration with Purchasing and Translational Medicine - Lead assay development and validation , ensuring assay readiness aligned with clinical timelines - Manage biomarker timelines, budget, risk and quality plans - Ensure collection, shipment and analysis of samples comply with GCP and regulat...