Director, Patient 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.

• 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.

• Provide guidance for interactions with payers and regulators regarding patient-centered outcomes, including early scientific advice, HTA consultations, and marketing authorization defense.
• Coordinate a global strategy and delivery of COA evidence packages/dossiers to secure marketing authorization, label enhancement, and access/reimbursement success.
• Evaluate and address COA- and patient-experience-related questions/requests from health authorities, including the development of supportive reports, evidence dossiers, and responses to in-trial and exit interviews.

• Design and oversee the generation of COA evidence using qualitative and quantitative methods in line with international scientific standards and health authority guidance.
• Collaborate with clinical teams on licensing, translation, linguistic validation, and modality adjustments (e.g., eCOA/ePRO), as well as rater training development and implementation.

• Build and maintain strong relationships with internal and external stakeholders across therapeutic areas to understand the evolving context of Otsuka’s portfolio and support strategic approaches to drug development.
• Align with other patient-focused groups within Otsuka to identify synergies, foster collaboration, and facilitate knowledge sharing.

• Represent Otsuka in external forums and initiatives (e.g., C-Path, Duke Margolis, ISOQOL, ISPOR) to advance patient-centric outcomes and increase the success of Otsuka’s portfolio.
• Contribute to the development and revision of guidance documents issued by external bodies (e.g., FDA, EMA, HTA organizations).

• Provide input on the target product profile development and clinical development strategy from a COA and patient-centricity perspective.
• Translate COA data into actionable insights to support regulatory approval, access, and reimbursement for assigned clinical programs.
• Lead the development of COA evidence strategies across the product lifecycle, ensuring alignment with regulatory and market access requirements.

• Represent the COA function and manage effective communication with internal global/regional teams and external stakeholders.
• Collaborate with Clinical Development/Clinical Management teams to identify fit-for-purpose trial endpoints, adapt legacy measures, and develop new measures to support target populations and label claims.

• At least 7 years demonstrated expertise in designing and validating COA tools, including qualitative and quantitative research methodologies.
• Strong knowledge of clinical development, regulatory requirements and HTA standards for COA and patient experience data.
• Ability to lead cross-functional teams and external collaborations to advance patient-focused drug development.

• Project management experience

• Master’s degree…