Associate Director, Clinical Outcome Assessment

Role Summary

The Associate Director, COA develops and executes the COA strategy for one or more assigned clinical programs, applying qualitative and quantitative methods to support endpoint selection, evidence generation, and regulatory dossier input. The role operates with a high degree of independence on assigned programs, with Director-level oversight reserved for cross-program, indication-level, or enterprise-scope decisions. This role is part of a global cross-functional team and interacts with Global Clinical Development, Clinical Management, Regulatory Affairs, Biostatistics, Value Evidence, Global Medical Affairs, Pharmacovigilance, Patient Advocacy & Stakeholder Management functions to ensure clinical development programs reflect appropriate patient-centric endpoint strategy and value differentiation needs in alignment with the target product profile across the product lifecycle.

Job Responsibilities

Endpoint & COA strategy

• Identify fit-for-purpose COAs (PRO, ClinRO, ObsRO, PerfO) for assigned programs, in the context of label claims, regulatory submissions, and value evidence needs.
• Apply qualitative methods (concept elicitation, concept confirmation, cognitive debriefing) and quantitative/psychometric methods to determine measurement properties, responder definitions, and meaningful-change.
• Investigate the extent to which COA endpoints are available, fit-for-purpose, and have regulatory precedent for assigned programs, in support of the product target label claim and value evidence needs.

Regulatory & evidence generation

• Design and lead generation of COA evidence (qualitative/quantitative) for assigned programs, per international scientific standards and health authority guidance.
• Contribute COA sections to regulatory dossiers, briefing packages, and health authority responses for assigned programs.
• Lead Patient Experience & COA evidence dossier development for external stakeholders (eg, regulatory and health authorities)
• Coordinate COA licensing, translation, linguistic validation, and rater training for assigned programs, in collaboration with Global Clinical Development/Clinical Management.

Cross-functional & external

• Serve as the COA point of contact on assigned clinical study teams; represent COA in cross-functional program governance.
• Represent Otsuka at relevant external conferences and working groups (e.g., ISPOR, ISOQOL) as assigned.
• Build and maintain relationships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and vendors relevant to assigned programs.

Required Qualifications

• Bachelor’s degree in outcomes research, health services research, epidemiology, psychology, public health, or a related field.
• 7+ years of relevant experience in COA/PRO or patient-centered outcomes research, with at least 5 years specific to patient-centered/COA work.
• Demonstrated experience independently designing and executing COA evidence-generation projects.
• Working knowledge of FDA/EMA patient focused drug development guidances and their application to clinical development.
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective, and product development processes at all life cycle stages.
• Strong knowledge of the legal and regulatory environment influencing clinical development plans, labeling, and promotional claims.
• Experience partnering and collaborating with external vendors and academic/clinical investigators.
• Excellent written and verbal communication skills; ability to present technical COA concepts to cross-functional and senior audiences.

Preferred Qualifications

• Master or Doctoral degree in a relevant field.
• Experience supporting a regulatory submission (NDA/BLA/MAA) with COA content.
• Prior conference presentation or publication in COA/PRO methodology.
• Experience across multiple therapeutic areas.

Scope, Autonomy & External Representation

• Scope: one program, or a small cluster of related indications.
• Autonomy: owns COA strategy for assigned programs; escalates cross-program or enterprise-level decisions to a Director.
• External representation: attends and increasingly presents at external scientific forums; not a primary Otsuka stakeholder for external interactions.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.