Director, Patient Centered Outcomes Research

About the role

The Director, Patient-Focused Evidence (PFE) is an experienced scientific expert in patient-focused evidence and clinical outcome assessment (COA) measurement, contributing to and supporting development programs at a global level. This role leads the development and execution of PFE strategies for assigned programs, including working cross-functionally to plan and implement patient experience data (PED) generation and providing expertise on COA measurement for studies — ultimately ensuring that the patient voice is robustly represented in regulatory submissions and informs decisions that improve patient access and outcomes.

Responsibilities

• Lead development and execution of evidence strategies for collecting and integrating patient experience data (PED) for assigned programs, in close collaboration with key internal and external stakeholders, aligned with clinical development timelines and health authority expectations.
• Lead the development of COA measurement plans for assigned programs, including development of conceptual models, selecting, developing, and validating COA measures and endpoints for clinical and non-interventional studies (NIS).
• Ensure integration of patient-experience/benefit considerations and related evidence gaps in program-level planning, as a key component of integrated evidence plans (IEP), throughout the drug research, development, and commercialization stages.
• Lead design, execution, and delivery of non-interventional studies for generating regulatory-grade Patient Experience Data (PED), and COA development and validation projects.
• Serve as subject matter expert on qualitative, quantitative, and mixed-methods methodologies of PED and COA measurement for assigned programs; represent PRWE in relevant cross-functional governance bodies and scientific forums.
• Ensure high impact of deliverables by understanding business priorities and addressing customer needs within a matrix organizational structure.
• Ensure quality, reproducibility, and compliance of all PFE deliverables with applicable regulatory guidelines and best practice [e.g., ISPOR good practice guidance, FDA PFDD guidance, China FDA guidance, and EMA PED reflection paper] and internal quality standards.
• Build and maintain partnerships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and CROs, aligned with program and organizational priorities.
• Represent Company at scientific conferences and therapeutic area-specific meetings; contribute to peer-reviewed publications, conference presentations, and scientific communications; engage in relevant industry working groups on PFE methodology and standards.
• Lead PED/COA-related aspects in regulatory engagements and submissions for assigned programs, e.g., preparation of COA measure and PED dossiers.
• Contribute to patient engagement activities related to program strategy or clinical studies, including patient advisory boards, panels, and councils.
• Manage project-related contracting, budget, and resources; oversee vendor and partner management for assigned programs.

Qualifications

• Master’s degree (or higher) in socio-behavioral sciences, health outcomes measurement, psychology, behavioral sciences, ethnography, psychometrics, or related field.
• 10+ years in patient-centered research, patient-focused drug development, or outcomes research in the Pharmaceutical/Biotech industry.
• Strong understanding of clinical drug development and lifecycle management; demonstrable experience supporting key phases of a clinical program (e.g., initiation of Phase 3, regulatory filing).
• Deep understanding of PFDD guidance and regulatory expectations on PFE and COA measurement, internationally (including FDA, EMA, Chinese FDA).
• Demonstrable experience and knowledge of designing and implementing PED studies – applying qualitative, quantitative, and mixed-methods.
• Demonstrable expertise in developing and validating COA measures.
• Demonstrable experience contributing to COA/PED-related aspects in regulatory engagements and submissions.

Benefits

• Health insurance
• Paid time off (PTO)
• Retailment contributions
• Other perquisites

Pay Range

$172,000 - 258,000