Senior HEOR Manager/COA Strategy Lead m/f/d, Basel-Landschaft

Project overview

We are seeking an experienced Senior HEOR Manager/Clinical Outcome Assessment (COA) Strategy Lead to drive the development, implementation, and execution of strategic COA plans across a diverse portfolio of clinical development programs and therapeutic areas. This role serves as the company’s subject matter expert in COA and Patient-Reported Outcomes (PROs), ensuring that clinical outcome strategies support regulatory, reimbursement, and health technology assessment (HTA) objectives globally.

The successful candidate will provide scientific leadership across cross-functional teams, oversee COA methodology and validation activities, and ensure patient-centered endpoints are developed and implemented in accordance with regulatory expectations and industry best practices.

Project details

Basel

Start date: 01/12/2026

End date:

30/11/2027

Key Responsibilities

COA Strategy Development & Leadership

Clinical Development Support

Study protocols

Statistical Analysis Plans (SAPs)

Psychometric Analysis Plans

Clinical Study Reports (CSRs)

Briefing books and regulatory submissions

COA Project Execution

Clinical Development

Medical Affairs, Regulatory Affairs

Market Access

Data Analysis, Reporting & Publications

Regulatory & Scientific Engagement

Thought Leadership & External Engagement

C-Path Institute

PCORI

ISPOR

ISOQOL

Required Qualifications

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Find more vacancies at: coopers.ch

Job profile (M4R79H)

Life Sciences - Clinical & Safety

Basel-Landschaft

Contracting

Part Time

Immediately - 30/11/2027

HEOR, Clinical Outcome Assessment , Data Analysis

• 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.
• Guide clinical teams in the selection, implementation, and interpretation of COAs throughout the clinical trial lifecycle.
• Provide expert input into clinical documents, including:
• 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.
• Lead and oversee the scientific execution of COA initiatives from concept through completion.
• Collaborate with internal stakeholders, including
• Manage external vendors delivering qualitative research, translations, linguistic validation, and eCOA implementation activities.
• Ensure adherence to timelines, quality standards, and project objectives.
• 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
• 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.
• Maintain deep expertise in COA, PRO, and health outcomes research methodologies.
• Monitor emerging scientific developments, guidance, and best practices from organizations such as:
• Integrate innovative approaches and methodological advancements into development programs.
• Represent the organization externally through scientific collaborations, publications, and professional engagements.
• 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.
• Start: 2027-11-30
• Location: Basel-Landschaft, CH