Clinical Outcome Assessment Lead – Patient-Centric Impact

Excelya; Paris; On-site; EUR 90,000 - 120,000; Full time

Job summary

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

The successful candidate will define COA strategy, select and validate PROs, ClinROs, ObsROs and PerfOs, and collaborate with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.

Qualifications

• Advanced degree in Life Sciences or related field.
• Experience in a COA role in pharma/biotech.
• Strong understanding of patient-focused drug development.
• Knowledge of qualitative and quantitative research methodologies.
• Familiarity with global regulatory expectations for patient-centered endpoints.
• Excellent project and stakeholder management and communication.

Responsibilities

• Define and lead the COA strategy across clinical development programs.
• Ensure patient perspective is incorporated into 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.

Skills

COA strategy

Patient-focused outcomes

Regulatory knowledge

Project management

Cross-functional collaboration

Education

Advanced degree in Life Sciences or related field

Job description

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

The successful candidate will define COA strategy, select and validate PROs, ClinROs, ObsROs and PerfOs, and collaborate with Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and external vendors.