Clinical Outcome Assessment Lead

Excelya; France; On-site; EUR 90,000 - 140,000; Full time

Job summary

Excelya seeks a Clinical Outcome Assessment (COA) Lead to drive COA strategy across novel clinical development programs, ensuring the patient voice is integrated into study design and that meaningful outcomes demonstrate real treatment impact.

You will select, develop, and validate COA instruments (PROs, ClinROs, ObsROs, PerfOs) and provide scientific expertise on patient-centered outcomes, collaborating with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and

Qualifications

• Advanced degree in Life Sciences, Psychology, Public Health, Epidemiology, or a related field.
• Proven experience in a COA role within the pharmaceutical or biotechnology industry.
• Strong understanding of patient-focused drug development and outcome measurement.
• Knowledge of qualitative and quantitative research methodologies.
• Familiarity with global regulatory expectations regarding patient-centered endpoints.
• Excellent project management, stakeholder management, and communication skills.
• Comfortable working in a global, cross-functional environment.

Responsibilities

• Define and lead the COA strategy across clinical development programs.
• Ensure the patient perspective is incorporated into study design and endpoint selection.
• Select, develop, and validate appropriate COA instruments (PROs, ClinROs, ObsROs, PerfOs).
• Provide scientific expertise on patient-centered outcomes and endpoint strategy.
• Collaborate cross-functionally with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.
• Support regulatory submissions, publications, and scientific communications related to COA data.
• Oversee COA implementation and data quality throughout clinical studies.

Skills

COA knowledge

Patient-focused development

Qualitative/Quantitative methods

Regulatory awareness

Cross-functional collaboration

Project management

Communication skills

Global teamwork

Education

Advanced degree (Life Sciences / Psychology / Public Health / Epidemiology)

Job description

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are seeking a Clinical Outcome Assessment (COA) Lead to drive COA strategy across innovative clinical development programs, ensuring the patient voice is integrated into clinical research and that meaningful outcomes are used to demonstrate the real impact of treatments on patients' lives.

Key Responsibilities

• Define and lead the COA strategy across clinical development programs.
• Ensure the patient perspective is incorporated into study design and endpoint selection.
• Select, develop, and validate appropriate COA instruments (PROs, ClinROs, ObsROs, PerfOs).
• Provide scientific expertise on patient-centered outcomes and endpoint strategy.
• Collaborate cross-functionally with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.
• Support regulatory submissions, publications, and scientific communications related to COA data.
• Oversee COA implementation and data quality throughout clinical studies.

Qualifications

• Advanced degree in Life Sciences, Psychology, Public Health, Epidemiology, or a related field.
• Proven experience in a COA role within the pharmaceutical or biotechnology industry.
• Strong understanding of patient-focused drug development and outcome measurement.
• Knowledge of qualitative and quantitative research methodologies.
• Familiarity with global regulatory expectations regarding patient-centered endpoints.
• Excellent project management, stakeholder management, and communication skills.
• Comfortable working in a global, cross-functional 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'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.