Biomarker Operations Lead

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 regulatory requirements
• Work cross‑functionally with Translational Medicine, Clinical Operations, Clinical Logistics, Data Management and Therapeutic Areas
• Contribute to clinical documentation (protocols, ICFs, laboratory manuals) and respond to regulatory questions
• Provide training and guidance to clinical sites and teams on biomarker sample handling
• Support biomarker data review and query resolution

Candidate Profile

• Proven experience in biomarker operations or related clinical research management roles.
• Strong knowledge of biomarker methodologies, clinical trial processes, regulatory compliance and in drug development.
• Excellent organizational, communication, and leadership skills.
• Degree in Life Sciences, Biology, Biotechnology or related field; advanced degrees preferred.
• Ability to work collaboratively in a dynamic and cross-functional team environment.
• Proficiency in English; additional language skills are an asset.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.