COA Strategy Lead for Patient-Centric Outcomes

Excelya; United Kingdom; À distance; GBP 90 000 - 130 000; Plein temps

Résumé du poste

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 real treatment impact on patients' lives.

The role requires leadership in defining COA approaches, validating instruments, and collaborating with global teams to support regulatory submissions and publications.

Qualifications

• Advanced degree in Life Sciences or related field.
• Proven COA experience in pharma or biotech 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.

Responsabilités

• 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 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 vendors.
• Support regulatory submissions, publications, and scientific communications related to COA data.
• Oversee COA implementation and data quality throughout clinical studies.

Connaissances

COA strategy

Patient-centered outcomes

Cross-functional collaboration

Project management

Regulatory awareness

Formation

Advanced degree in Life Sciences or related field

Experience in COA role

Description du poste

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 real treatment impact on patients' lives.

The role requires leadership in defining COA approaches, validating instruments, and collaborating with global teams to support regulatory submissions and publications.