Clinical Outcome Assessment Lead: Patient-Centered Strategy

Excelya

Brussel

On-site

EUR 90,000 - 120,000

Full time

11 days ago

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Job summary

Excelya is seeking a Clinical Outcome Assessment (COA) 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.

You will define and lead COA strategy, select and validate COA instruments, collaborate across Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and vendors.

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

Project management
Stakeholder management
Communication skills
Cross-functional collaboration
COA strategy
Qualitative and quantitative research
Regulatory knowledge
Patient-centered outcomes

Education

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

Job description

Excelya is seeking a Clinical Outcome Assessment (COA) 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.

You will define and lead COA strategy, select and validate COA instruments, collaborate across Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs, HEOR, and vendors.

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