The Opportunity:The Senior Director, Patient-Reported Outcomes (PRO) provides scientific and strategic expertise for the integration of patient-centered outcomes into clinical development programs. This individual serves as a key PRO subject matter expert and leads the development and execution of PRO strategies for assigned programs in support of clinical development, regulatory, market access, and scientific communication objectives. Working closely with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, Clinical Operations, and other cross-functional partners, the Senior Director will translate patient-centered evidence needs into practical study plans and deliverables from development through registration and lifecycle management. This role is initially an individual contributor position with the opportunity to assume people-management responsibilities as the organization grows.
Key responsibilities include:
- 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 possesses 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.
Preferred Skills:- Experience developing or implementing PRO strategy in oncology clinical development; experience in solid tumors, including lung cancer (particularly NSCLC), pancreatic cancer, or other RAS-driven malignancies is preferred.
- Experience supporting Phase 2 and/or Phase 3 development programs and working with clinical trial teams on PRO operationalization, analysis, interpretation, and reporting.
- Experience working with external research vendors, consultants, academic collaborators, patient organizations, or other partners involved in patient-centered outcomes research.
- Experience contributing to regulatory or HTA interactions, scientific publications, or cross-functional capability-building activities related to PROs or clinical outcome assessments.
#LI-VN1 #LI-Remote
