Lead Clinical Outcome Assessment and Patient-Reported Outcome Strategies
Join our team in Basel to drive high-quality, patient-centred evidence generation across multiple therapeutic areas. This role supports clinical development programmes by creating robust data for regulatory, health technology assessment (HTA), and market access purposes.
Key Responsibilities
- Develop and execute COA/PRO strategies across clinical programmes.
- Advise study teams on the selection and implementation of COAs in clinical trials.
- Lead cross-functional COA projects with Clinical Development, Medical Affairs, Regulatory Affairs, Market Access, Biostatistics, and external vendors.
- Oversee COA validation activities, psychometric analyses, and interpretation of results.
- Support regulatory submissions, HTA dossiers, scientific publications, and conference presentations.
- Ensure compliance with FDA, EMA, and HTA requirements and industry best practices.
- Drive vendor management activities related to qualitative research, translations, and eCOA implementation.
- Stay current with developments in outcomes research and patient-centred evidence generation.
Required Qualifications
- Master's degree or PhD in Health Economics, Epidemiology, Psychology, Life Sciences, Pharmacy, Biostatistics, or a related field.
- Proven experience in HEOR, Outcomes Research, COA/PRO Strategy, or Patient-Centred Evidence Generation within the pharmaceutical industry.
- Strong knowledge of regulatory and HTA requirements.
- Experience working in global, cross-functional teams.
- Strong analytical, critical thinking, and problem-solving skills, with the ability to collaborate effectively in a matrix environment.
- Excellent project management and stakeholder engagement skills.
- Languages: English. German is nice to have.
Contract Details
- Contract Type: Temporary (12 months)
- Start Date: December 2026
- Location: Basel, Switzerland
- Workload: 100%