Associate Director, Clinical Outcome Assessment

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and implement the COA strategy for one or more designated clinical programs.

• Identify suitable PRO, ClinRO, ObsRO, and PerfO instruments for label claims, regulatory submissions, and value evidence requirements.

• Utilize qualitative methods such as concept elicitation, concept confirmation, and cognitive debriefing.

• Employ quantitative and psychometric methods to assess measurement properties, responder definitions, and meaningful change.

• Examine the availability of COA endpoints, their suitability, and regulatory precedents.

• Design and oversee qualitative and quantitative COA evidence generation in accordance with international scientific standards and health authority guidelines.

• Contribute COA sections to regulatory submissions, briefing packages, and responses to health authorities.

• Lead the development of Patient Experience and COA evidence dossiers for external stakeholders.

• Coordinate COA licensing, translation, linguistic validation, and rater training.

• Act as the COA point of contact on assigned clinical study teams.

• Represent COA in cross-functional program governance.

• Represent Otsuka at pertinent external conferences and working groups.

• Establish and maintain relationships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and other relevant entities.

⛳️ Requirements

• Bachelor’s degree in outcomes research, health services research, epidemiology, psychology, public health, or a related field.

• Over 7 years of relevant experience in COA/PRO or patient-centered outcomes research.

• Minimum of 5 years specifically focused on patient-centered/COA work.

• Proven experience in independently designing and executing COA evidence-generation projects.

• Solid understanding of FDA/EMA patient-focused drug development guidelines and their relevance to clinical development.

• Comprehensive knowledge of the pharmaceutical industry and global regulatory standards.

• Understanding of product development processes throughout all life-cycle stages.

• Strong familiarity with the legal and regulatory landscape affecting clinical development plans, labeling, and promotional claims.

• Experience in partnering and collaborating with external vendors and academic/clinical investigators.

• Exceptional written and verbal communication skills.

• Capability to present technical COA concepts to cross-functional teams and senior audiences.

• Master's or Doctoral degree in a relevant discipline is preferred.

• Experience in supporting an NDA/BLA/MAA regulatory submission with COA content is preferred.

• Previous conference presentations or publications in COA/PRO methodology are preferred.

• Experience across various therapeutic areas is preferred.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-sponsored 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.

• Additional company-provided benefits.

• Opportunity for incentives.