openleverjobgether
Senior Director, Patient Reported Outcomes
Jobgether
LocationUS
EmploymentFull-time
Posted2026-08-26T16:10:48.936000+00:00
Last observed2026-08-26 21:51:40.410433
Job idjobgether-jobgether:lever:81be4fcf-9673-46d6-b096-50f43a20d9e8
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Patient Reported Outcomes based in United States. This is a senior scientific and strategic role focused on integrating patient-centered outcomes into clinical development programs. You will serve as a subject matter expert in patient-reported outcomes (PROs) and shape evidence strategies across the development lifecycle. The role partners closely with Clinical Development, Biostatistics, Regulatory Affairs, Medical Affairs, and Clinical Operations. You will translate patient-centered evidence needs into practical study designs, endpoints, analyses, and scientific deliverables. Your expertise will contribute to regulatory interactions, market access strategies, publications, and benefit-risk assessments. Initially operating as an individual contributor, you will have the opportunity to take on people leadership as the organization expands. The environment is highly collaborative, scientifically rigorous, and focused on generating meaningful evidence that reflects the patient experience. Develop and lead patient-reported outcomes strategies for assigned clinical development programs, ensuring alignment with clinical, regulatory, market access, and scientific objectives. Recommend, implement, validate, and interpret appropriate PRO measures and patient-centered endpoints, including fit-for-purpose evaluations of existing instruments. Partner with cross-functional teams to integrate PRO objectives and assessments into study designs, protocols, schedules of assessments, statistical analysis plans, regulatory documentation, and publications. Plan and oversee qualitative and quantitative research activities supporting PRO evidence generation, including management of external vendors, consultants, and subject-matter experts. Provide methodological guidance on endpoint definitions, meaningful change thresholds, responder analyses, missing data, and interpretation of patient-centered evidence. Support the integration of PRO findings into broader benefit-risk assessments and clinical development decision-making. Contribute PRO expertise to regulatory authority and health technology assessment interactions, regulatory submissions, briefing documents, and product-labeling discussions. Engage external experts, patient stakeholders, research partners, and other relevant groups to strengthen patient-centered evidence strategies. Support the analysis, interpretation, and dissemination of PRO findings through clinical study reports, scientific publications, conference presentations, and other communications. Establish and improve processes, standards, and best practices for patient-focused drug development and clinical outcome assessments. Provide scientific guidance, coaching, and mentoring to colleagues while helping build organizational capabilities in PRO methodology. Requirements: Advanced degree such as 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. At least 13 years of relevant experience in patient-reported outcomes, patient-focused drug development, health outcomes research, or a related field within pharmaceutical, biotechnology, CRO, consulting, or academic environments. Demonstrated experience developing and implementing PRO strategies across clinical development programs, preferably including late-stage studies and 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 surrounding patient-focused drug development and clinical outcome assessments, with the ability to apply relevant
This page is generated from the committed OpenOpps static snapshot. Use the source posting or apply link for the employer's current canonical posting state.