Clinical Outcome Assessment Lead

Employers from Greece; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Excelya is seeking a Clinical Outcome Assessment Lead to drive COA strategy across clinical development programs and ensure the patient voice is integrated into research and that meaningful outcomes demonstrate real treatment impact.

The role requires developing and validating COA instruments, collaborating with global teams, and supporting regulatory submissions and scientific communications.

Qualifications

• Proven COA experience in pharma/biotech.
• Strong patient-focused development and outcome measurement.
• Knowledge of qualitative and quantitative research methods.
• Familiarity with global regulatory expectations for patient-centered endpoints.
• Excellent project management and stakeholder management; strong communication.
• Ability to work in a global, cross-functional environment.

Responsibilities

• Define and lead the COA strategy across clinical development programs.
• Ensure patient perspective informs study design and endpoint selection.
• Select, develop, and validate 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.

Education

Advanced degree in Life Sciences, Psychology, Public Health, Epidemiology, or a related field

Job description

at Excelya

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

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.

Requirements

• 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.

Benefits

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 modeloffering 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.