Senior Director, Patient Reported Outcomes

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.

Accountabilities:

• 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 guidance pragmatically.
• Experience supporting Phase 2 and/or Phase 3 clinical development programs and collaborating with clinical trial teams on PRO operationalization, analysis, interpretation, and reporting.
• Strong scientific judgment, analytical ability, and problem-solving skills, with the capacity to manage multiple priorities in a complex development environment.
• Excellent cross-functional collaboration and influencing skills, with the ability to communicate clear scientific rationale and guide decisions across disciplines.
• Exceptional written, verbal, and presentation skills, including the ability to explain complex PRO concepts to clinical, statistical, regulatory, and business audiences.
• Experience managing external research vendors, consultants, academic collaborators, patient organizations, or other partners involved in patient-centered outcomes research.
• Oncology experience is preferred, particularly in solid tumors such as lung cancer/NSCLC, pancreatic cancer, or other RAS-driven malignancies.
• Experience contributing to regulatory or HTA interactions, scientific publications, or organizational capability-building initiatives related to PROs or clinical outcome assessments is an advantage.

Benefits:

• Senior-level opportunity within a scientifically driven clinical development environment.
• Remote position available across the United States.
• Opportunity to influence patient-centered evidence strategies across the clinical development lifecycle.
• Cross-functional exposure to clinical development, biostatistics, regulatory affairs, medical affairs, clinical operations, and other disciplines.
• Opportunity to contribute to regulatory submissions, scientific publications, and external scientific communications.
• Initial individual-contributor scope with potential to assume people-management responsibilities as the organization grows.
• Opportunities to engage with external experts, patient stakeholders, research partners, and industry collaborators.
• Professional growth through meaningful scientific leadership and capability-building initiatives.
• Comprehensive benefits and compensation package, subject to the partner company's applicable employment terms.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.