Basel-Based Senior COA/PRO Strategy Lead

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

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.