Senior Clinical Outcomes Assessment (COA/PRO) Manager – HEOR

gloor & lang Pharma and Biotech Recruiting; Basel; On-site; CHF 140,000 - 180,000; Full time

Job summary

Global Pharmaceutical Company in Basel seeks an experienced Senior Clinical Outcomes Assessment (COA/PRO) Manager to shape COA strategies across clinical development and align with regulatory and HTA expectations.

The role interfaces with HEOR, market access, regulatory affairs and biostatistics, driving COA evidence generation for regulatory submissions and product labeling. 12-month assignment in Basel with global scope.

Qualifications

• Master's degree or PhD in Life Sciences, Psychology, or related field.
• 5+ years in Health Outcomes Research within pharma/biotech/consulting.
• Proven COA/PRO strategy, instrument validation and psychometrics experience.
• Understanding of qualitative and quantitative COA research and regulatory expectations.

Responsibilities

• Develop and lead COA strategies across clinical programs.
• Define COA plans, timelines and validation milestones for regulatory/HTA.
• Advise on PRO endpoints and COA instrument selection.
• Provide COA expertise for trial protocols, analysis plans, and reports.
• Lead COA projects from strategy to execution in a global matrix.

Skills

COA/PRO strategy

Stakeholder management

Cross-functional collaboration

Regulatory affairs

HEOR and market access

Project leadership

eCOA implementation

Education

Master's degree

PhD

Tools

eCOA

Job description

12-month temporary assignment | Basel | Global Pharmaceutical Company

For a global pharmaceutical company in Basel, we are looking for an experienced Senior Clinical Outcomes Assessment (COA/PRO) Manager with strong expertise in patient-centered outcomes research.

This is a highly visible scientific and strategic role at the interface of clinical development, regulatory affairs, HEOR and market access. You will shape COA strategies across clinical programs and ensure that outcome measures generate robust evidence for both regulatory and HTA decision-making.

Your responsibilities

• Develop and lead Clinical Outcome Assessment (COA) strategies across therapeutic areas and clinical development programs
• Define COA plans, timelines and validation milestones for regulatory and HTA purposes
• Advise clinical development teams on the selection and implementation of appropriate Patient-Reported Outcomes (PROs) and other COA endpoints
• Provide COA expertise for clinical trial protocols, statistical and psychometric analysis plans, clinical reports and related documentation
• Lead COA projects from strategy through execution in collaboration with internal stakeholders and external scientific partners
• Oversee content validation, psychometric validation and interpretation of COA results
• Ensure that psychometric evidence meets scientific standards for regulatory submissions, product labelling and HTA dossiers
• Collaborate closely with biostatistics, psychometrics, clinical development, data management, regulatory affairs, medical affairs and market access
• Lead or review COA analysis plans and scientific reports, ensuring a clear link between COA findings, clinical benefit and HTA requirements
• Contribute to regulatory interactions and submissions, including briefing documents, scientific advice and dossier content
• Support scientific publications, presentations and other evidence-generation activities
• Stay current with evolving COA methodologies, regulatory expectations and industry standards

Depending on experience, the role may also include aligning COA endpoints with broader HEOR and HTA evidence needs, overseeing external vendors and participating in cross-functional COA governance.

Your profile

• Master's degree or PhD in Life Sciences, Psychology, Sociology, Psychometrics, Pharmacy, Biostatistics or a related scientific discipline
• At least 5 years of relevant experience in Health Outcomes Research, preferably within the pharmaceutical, biotechnology or consulting environment
• Proven hands-on experience in COA/PRO strategy, instrument validation and psychometric methodologies within clinical drug development is essential
• In-depth understanding of qualitative and quantitative COA research, instrument development, validation and interpretation
• Ability to critically evaluate COA data and translate scientific findings into robust, regulatory-ready evidence
• Strong understanding of global regulatory requirements and their implications for clinical outcome strategies
• Experience with FDA and/or EMA regulatory expectations is highly desirable
• Understanding of electronic COA (eCOA) implementation, including migration from paper and BYOD approaches
• Proven ability to lead complex, cross-functional projects within a global matrix organisation
• Experience coordinating external vendors and scientific partners
• Strong stakeholder management, communication and problem-solving skills
• Ability to influence and collaborate effectively without direct hierarchical authority
• Proactive, collaborative and scientifically rigorous working style

The assignment

This is a 12-month temporary position based in Basel, starting on 1 December 2026, within an international Big Pharma environment.

The role offers the opportunity to take scientific ownership of COA strategies within complex global development programs and work closely with experts across clinical development, regulatory affairs, HEOR and market access.