[Hiring] Associate Director, Clinical Outcome Assessment @Otsuka Pharmaceutical Co., Ltd.

Role Description

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 various 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.
  • Apply qualitative methods (concept elicitation, concept confirmation, cognitive debriefing) and quantitative/psychometric methods.
  • Investigate the availability and regulatory precedent of COA endpoints for assigned programs.
• Regulatory & evidence generation:
  • Design and lead generation of COA evidence for assigned programs.
  • Contribute COA sections to regulatory dossiers and health authority responses.
  • Lead Patient Experience & COA evidence dossier development for external stakeholders.
  • Coordinate COA licensing, translation, linguistic validation, and rater training.
• Cross-functional & external:
  • Serve as the COA point of contact on assigned clinical study teams.
  • Represent Otsuka at relevant external conferences and working groups.
  • Build and maintain relationships with academic institutions, patient advocacy groups, and vendors.

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.
• Demonstrated experience independently designing and executing COA evidence-generation projects.
• Working knowledge of FDA/EMA patient focused drug development guidances.
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements.
• Strong knowledge of the legal and regulatory environment influencing clinical development plans.
• Experience partnering and collaborating with external vendors and academic/clinical investigators.
• Excellent written and verbal communication skills.

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.
• External representation: attends and presents at external scientific forums.

Competencies

• Accountability for Results
• Strategic Thinking & Problem Solving
• Patient & Customer Centricity
• Impactful Communication
• Respectful Collaboration
• Empowered Development

Salary Information

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity.

Application Deadline

This will be posted for a minimum of 5 business days.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment insurance.
• Short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.