Lead, Clinical Outcome Assessment & Patient-Centric Research

Employers from Greece; United States; Remoto; USD 140.000 - 190.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Formazione

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

Descrizione del lavoro

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.