Senior Director, Patient Reported Outcomes

Key Responsibilities

• Develop and lead PRO strategy for assigned clinical development programs, ensuring alignment with clinical, regulatory, and market access objectives.
• Recommend and support the selection, implementation, validation, and interpretation of PRO measures and patient-centered endpoints, including fit-for-purpose assessment of existing instruments.
• Partner with cross-functional teams to incorporate PRO objectives and assessments into study designs, protocols, schedules of assessments, statistical analysis plans, regulatory documents, and publications.
• Plan and oversee qualitative and quantitative research activities supporting PRO evidence generation, including vendor and external expert management as appropriate.
• Provide methodological guidance on endpoint definitions, meaningful change thresholds, responder analyses, missing data, interpretation of results, and integration of PRO findings into benefit-risk assessment.
• Contribute PRO expertise to interactions with regulatory authorities and health technology assessment agencies and to regulatory submissions, briefing documents, and product-labeling discussions; engage external experts and patient stakeholders as needed.
• Support the analysis, interpretation, and dissemination of PRO evidence through study reports, publications, presentations, and other scientific communications.
• Contribute to the development of fit-for-purpose processes, standards, and best practices for patient-focused drug development, and provide coaching or mentoring to colleagues as appropriate.

Required Skills, Experience and Education

• Advanced degree (eg, Ph.D., Sc.D., Dr.P.H., Psy.D., M.D., Pharm.D., M.P.H., M.S., or equivalent) in psychology, psychometrics, epidemiology, public health, health outcomes research, behavioral science, or a related discipline.
• Candidate should possess a minimum of 13 years of relevant experience in patient-reported outcomes, patient-focused drug development, health outcomes research, or a related field within the pharmaceutical, biotechnology, CRO, consulting, or academic environment; level will be commensurate with experience.
• Demonstrated experience developing and implementing PRO strategies for clinical development programs, preferably including late-stage studies and support for regulatory interactions or submissions.
• Strong expertise in qualitative and quantitative PRO methodologies, including instrument selection and development, content validity, psychometric evaluation, meaningful change, and interpretation of treatment benefit.
• Working knowledge of global regulatory expectations related to patient-focused drug development and clinical outcome assessments, with the ability to apply guidance pragmatically to development programs.
• Demonstrated ability to work effectively in cross-functional teams, manage multiple priorities, and influence decisions through clear scientific rationale and collaborative partnership.
• Excellent written and verbal communication and presentation skills, with experience translating technical PRO concepts for clinical, statistical, regulatory, and business audiences.