Biomarkers project Lead

About the Role

Excelya is looking for a motivated and strategic BMK Strategy Lead to drive biomarker strategy development and execution across clinical research programs. As the BMK Strategy Lead, you will lead and drive the biomarker strategy to support project development from lead optimization through life‑cycle management, in close collaboration with project teams and internal/external partners.

Key Responsibilities

• Define, drive, and implement integrated biomarker strategies across the full drug development lifecycle, from lead optimization through late‑stage clinical development and life‑cycle management, ensuring alignment with project objectives, clinical plans, and regulatory expectations.
• Oversee the generation, analysis, interpretation, and integration of biomarker data across in vitro, in vivo, and ex vivo platforms to support project decision‑making, including indication selection, patient stratification, and combination strategies.
• Coordinate biomarker-related activities with internal experts and external partners, including CROs and academic collaborators, and contribute to the design of translational and pharmacology studies.
• Work closely with clinical development, biostatistics, modeling, data management, translational medicine, and regulatory teams to ensure operational excellence and biomarker readiness for clinical studies.
• Prepare and review biomarker-related scientific and regulatory documentation, including biomarker plans, clinical protocols, Investigator Brochure, IND/CTA content, and governance materials.
• Support regulatory interactions by providing biomarker data summaries, scientific rationales, and responses to health authority questions.
• Define biomarker‑based decision criteria for project advancement and contribute to governance and portfolio decision processes.
• Proactively identify opportunities for innovation in biomarker methodologies, technologies, and approaches, and contribute to knowledge sharing and continuous improvement within an international, cross‑functional environment.

Candidate Profile

• Proven experience in biomarker strategy development in clinical research or pharmaceutical industry.
• Strong understanding of biomarker science, translational medicine, and clinical trial processes.
• Excellent leadership, communication, and project management skills.
• Ability to work collaboratively across diverse teams and manage external partnerships.
• Advanced degree (MSc, PhD, or equivalent) in Life Sciences, Molecular Biology, Biotechnology or related fields.
• Fluent in English

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.