Associate Director, Clinical Outcome Assessment

Job Description:

• Develop and execute COA strategy for one or more assigned clinical programs
• Identify fit-for-purpose PRO, ClinRO, ObsRO, and PerfO instruments for label claims, regulatory submissions, and value evidence needs
• Apply qualitative methods including concept elicitation, concept confirmation, and cognitive debriefing
• Apply quantitative and psychometric methods to determine measurement properties, responder definitions, and meaningful change
• Investigate COA endpoint availability, fitness for purpose, and regulatory precedent
• Design and lead qualitative and quantitative COA evidence generation according to international scientific standards and health authority guidance
• Contribute COA sections to regulatory dossiers, briefing packages, and health authority responses
• Lead Patient Experience and COA evidence dossier development for external stakeholders
• Coordinate COA licensing, translation, linguistic validation, and rater training
• 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
• Build and maintain relationships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and relevant vendors

Requirements:

• 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
• 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 global regulatory requirements
• Understanding of product development processes across 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
• Master’s or Doctoral degree in a relevant field preferred
• Experience supporting an NDA/BLA/MAA regulatory submission with COA content preferred
• Prior conference presentation or publication in COA/PRO methodology preferred
• Experience across multiple therapeutic areas preferred

Benefits:

• Comprehensive medical, dental, vision, and prescription drug coverage
• Company-provided basic life insurance
• Accidental death and dismemberment insurance
• Short-term and long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• Generous 401(k) match
• Flexible time off
• Paid holidays
• Paid leave programs
• Other company-provided benefits
• Incentive opportunity