Senior Director, Patient Reported Outcomes

About the role

This leader will shape the strategy for patient-reported outcomes across clinical development programs, with a strong emphasis on late-stage studies and regulatory readiness. The role will partner closely with clinical, regulatory, and cross-functional stakeholders to ensure patient voice and outcomes evidence are integrated into study design, analysis, and decision-making. This is a highly visible opportunity to influence patient-focused development practices, external engagement, and the communication of outcomes data to key audiences.

Responsibilities

• Lead the development and execution of PRO strategies aligned with clinical and regulatory goals.
• Support the implementation and validation of PRO measures across clinical programs.
• Collaborate with cross-functional teams to integrate PRO objectives into study designs.
• Oversee research activities for PRO evidence generation and manage vendor relationships.
• Provide methodological guidance on endpoint definitions and analysis interpretation.
• Contribute PRO expertise to regulatory submissions and discussions with health authorities.
• Support the dissemination of PRO findings through publications and presentations.
• Develop best practices for patient-centered development processes.

Qualifications

• Advanced degree in psychology, epidemiology, public health, or a related discipline.
• Minimum of 13 years of experience in patient-reported outcomes or health outcomes research within pharma, biotech, or academic environments.
• Proven expertise in developing PRO strategies for clinical programs, particularly late-stage studies.
• Strong knowledge of qualitative and quantitative methodologies related to PRO instruments and evaluations.
• Familiarity with global regulatory expectations for patient-focused drug development.
• Ability to collaborate across functional teams and manage competing priorities.
• Excellent communication skills, with experience simplifying complex PRO concepts for diverse audiences.

Benefits

• Opportunity for future people-management responsibilities.
• Engagement with external experts and patient stakeholders.
• Participation in cutting-edge clinical development programs.
• Ability to influence regulatory and market access strategies.
• Remote work flexibility.

Location: Remote – US based candidates only, no visa sponsorship available

Compensation: $175,000 – $210,000 annually