Senior HEOR Manager/COA Strategy Lead

Location: Basel

Start date: 01/12/2026

End date:

30/11/2027

Key Responsibilities

COA Strategy Development & Leadership

• Lead the development, creation, and execution of strategic COA plans across clinical development programs and therapeutic areas.
• Own and maintain the COA Strategy Document for assigned programs, including timelines, evidence-generation plans, and validation milestones for regulatory and HTA submissions.
• Provide strategic guidance on the selection and optimization of COAs for clinical trials to support clinical, regulatory, and market access objectives.
• Ensure alignment of COA strategies with global regulatory requirements and evolving scientific standards.

Clinical Development Support

• Guide clinical teams in the selection, implementation, and interpretation of COAs throughout the clinical trial lifecycle.
• Provide expert input into clinical documents, including:

Study protocols

Statistical Analysis Plans (SAPs)

Psychometric Analysis Plans

Clinical Study Reports (CSRs)

Briefing books and regulatory submissions

• Serve as the accountable owner for COA-related content within protocols and SAPs.
• Ensure COA-related responsibilities are appropriately defined within program RACI frameworks across Clinical Operations, Biostatistics, Regulatory Affairs, and other functions.

COA Project Execution

• Lead and oversee the scientific execution of COA initiatives from concept through completion.
• Collaborate with internal stakeholders, including

Clinical Development

Medical Affairs, Regulatory Affairs

Market Access

• Manage external vendors delivering qualitative research, translations, linguistic validation, and eCOA implementation activities.
• Ensure adherence to timelines, quality standards, and project objectives.

Data Analysis, Reporting & Publications

• Partner with biostatisticians, psychometricians, data managers, and clinicians to analyze and interpret COA data.
• Lead development of COA analysis plans and review psychometric analysis reports.
• Ensure COA findings are clearly linked to clinical benefit, patient value, and HTA decision-making criteria.
• Contribute to and review: Regulatory dossiers, Scientific advice packages, FDA and EMA briefing documents, White papers, Manuscripts, Poster and oral presentations

Regulatory & Scientific Engagement

• Lead preparation of COA-related documentation for regulatory interactions and submissions.
• Support meetings with health authorities and scientific advisory bodies.
• Prepare and review dossiers, briefing books, scientific advice materials, and other regulatory communications.
• Collaborate closely with Regulatory Affairs, Clinical Development, and Medical Writing teams.

Thought Leadership & External Engagement

• Maintain deep expertise in COA, PRO, and health outcomes research methodologies.
• Monitor emerging scientific developments, guidance, and best practices from organizations such as:

C-Path Institute

PCORI

ISPOR

ISOQOL

• Integrate innovative approaches and methodological advancements into development programs.
• Represent the organization externally through scientific collaborations, publications, and professional engagements.

Required Qualifications

• Master’s degree or PhD in Life Sciences
• Minimum 5 years of experience in Health Outcomes Research, Clinical Outcomes Assessment, Patient-Reported Outcomes, or related fields.
• Demonstrated expertise in COA and PRO methodologies, Instrument development and validation, Psychometric evaluation, Regulatory requirements and submissions
• Proven track record leading cross-functional and global projects.
• Deep understanding of qualitative and quantitative COA research methodologies.
• Ability to critically evaluate and interpret COA data and psychometric evidence.
• Experience with Content validation, Linguistic validation, Cultural adaptation, Electronic COA (eCOA) implementation, Regulatory-ready evidence generation
• Familiarity with BYOD and modern eCOA migration standards.
• Strong leadership skills with experience working in matrix organizations.
• Ability to lead without formal authority and influence diverse stakeholders.
• Experience managing external vendors and strategic partnerships.
• Excellent communication, presentation, and stakeholder engagement skills.