Director, Patient Experience Data & Clinical Outcome Assessments (PED&COA)

Job Summary: The Director of Patient Experience Data and Clinical Outcome Assessments (PED&COA) leads the strategic integration of patient-centered outcomes into assigned global assets and programs. This role encompasses early development, regulatory submissions, post-marketing studies, and life-cycle management, ensuring patient perspectives are embedded throughout the drug development process. As a key member of the Global Integrated Evidence & Innovation team, the Director (PED&COA) will develop and execute a scientifically rigorous, patient-focused global strategy for Patient-Centered Outcomes Research (PCOR). This role ensures alignment with FDA guidance on patient-focused drug development (PFDD), regulatory expectations, and health technology assessment (HTA) requirements, while advancing Otsuka's commitment to create innovative, high-quality products for better health worldwide. Job Description: Patient-Centered Outcomes Research (PCOR): High-level accountability for the patient-centric outcomes endpoint strategy, ensuring alignment with clinical development plans, protocols, analysis plans, clinical study reports, labeling discussions, and briefing packages. Assess and deliver guidance on disease/therapeutic areas and early projects requiring COA endpoints or components (e.g., patient/caregiver diaries) to support primary/secondary endpoints and patient experience assessments. Investigate the availability, fit-for-purpose status, and regulatory precedence of COA endpoints to meet project needs and support product target label claims and value evidence requirements. Regulatory and Market Access Strategy: Provide guidance for interactions with payers and regulators regarding patient-centered outcomes, including early scientific advice, HTA consultations, and marketing authori