Biomarkers Project Lead H/F - Excelya

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.

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 lifecycle 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 latestage clinical development and lifecycle 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 decisionmaking, 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 biomarkerbased 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, crossfunctional environment.

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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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.

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