Senior Director, Patient Reported Outcomes

OpenKrill; United States; Sur place; USD 232 000 - 290 000; Plein temps

Résumé du poste

Revolution Medicines is a global oncology company focused on RAS-addicted cancers, advancing oral RAS(ON) inhibitors. The Senior Director, Patient-Reported Outcomes (PRO) provides strategic PRO expertise across development, regulatory, and market access objectives while guiding PRO evidence generation and dissemination.

The role demands leadership in PRO strategy, strong cross-functional collaboration, and expertise in translating PRO concepts for regulatory submissions and publications.

Qualifications

• Advanced degree in psychology, psychometrics, epidemiology, public health, health outcomes research, behavioral science, or related field.
• Minimum 13 years of PRO or related experience in pharma/biotech/CRO/consulting/academia.
• Proven ability to develop and implement PRO strategies for late-stage development and regulatory interactions.

Responsabilités

• Develop and lead PRO strategy for assigned programs aligned with regulatory objectives.
• Select, validate, and interpret PRO measures and endpoints.
• Collaborate with cross-functional teams to integrate PRO into study designs and analyses.
• Oversee qualitative and quantitative PRO research activities and manage external vendors.
• Provide methodological guidance on PRO endpoints, meaningful change, and interpretation.
• Support regulatory submissions and interactions with HTA bodies; engage external experts as needed.
• Disseminate PRO evidence through reports, publications, and presentations.
• Coach colleagues and help establish best practices for patient-focused development.

Connaissances

PRO methodologies (qualitative)

PRO methodologies (quantitative)

Cross-functional collaboration

Scientific communication

Study design input & interpretation

Formation

Advanced degree in health outcomes/related field

13+ years PRO experience

Description du poste

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

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-RemoteThe base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Base Pay Salary Range$232,000-$290,000 USD

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

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