Gi Group (United Kingdom)

For a leading pharmaceutical company, we are looking for a qualified

General Information:

• Location: Basel
• Start: 01.12.2026
• Duration: 12 months

Your Responsibilities:

• Develop and execute global Clinical Outcome Assessment (COA) and Patient-Reported Outcomes (PRO) strategies across clinical development programs.
• Own and maintain COA Strategy Documents, including validation activities and regulatory/HTA milestones.
• Provide expert guidance on the selection, implementation, and interpretation of COA/PRO endpoints and instruments throughout the clinical trial lifecycle.
• Lead cross-functional COA projects and coordinate internal stakeholders and external vendors.
• Oversee COA validation activities, including content validity, psychometric validation, score interpretation, and evidence generation.
• Support COA data analysis and the preparation of regulatory submissions, HTA dossiers, publications, and scientific presentations.
• Ensure compliance with global regulatory requirements, industry standards, and best practices related to COA/PRO research.

Your Profile:

• Master’s degree in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics, or a related field; PhD preferred.
• Minimum 5 years of experience in Health Economics & Outcomes Research (HEOR), Outcomes Research, or COA/PRO-related functions within the pharmaceutical, biotech, or healthcare industry.
• Strong expertise in Clinical Outcome Assessments (COA), Patient-Reported Outcomes (PRO), instrument validation, psychometric methods, and qualitative and quantitative outcomes research.
• Proven ability to develop and implement global COA/PRO strategies supporting clinical development, regulatory submissions, HTA requirements, market access objectives, and evidence-generation activities.
• In-depth understanding of regulatory requirements, industry standards, eCOA implementation, translation and linguistic validation, cultural adaptation, and digital outcome assessment methodologies.
• Demonstrated experience leading cross-functional teams, managing external vendors, and collaborating effectively with diverse internal and external stakeholders in a matrix environment.
• Fluent English communication skills, combined with strong stakeholder management, problem-solving, influencing, and collaboration abilities; experience with HTA evidence requirements, Real-World Evidence (RWE), health economics, and regulatory authority interactions (e.g., FDA, EMA) is highly desirable.