Associate Director, Clinical Outcome Assessments, COA

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

📋 Description

• Create and implement COA strategies for one or more designated clinical programs.

• Identify appropriate PRO, ClinRO, ObsRO, and PerfO measures for the assigned programs.

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

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

• Explore the availability of COA, its suitability, and relevant 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.

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

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

• Represent COA in cross-functional program governance meetings.

• Represent Otsuka at relevant external conferences and working groups.

• Establish and nurture relationships with academic institutions, patient advocacy organizations, clinical investigators, data vendors, and other relevant partners.

• Own the COA strategy for assigned programs and escalate cross-program or enterprise-level decisions to a Director.

⛳️ Requirements

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

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

• At least 5 years specifically focused on patient-centered/COA work.

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

• Familiarity with FDA/EMA patient-focused drug development guidelines and their application to clinical development.

• In-depth understanding of the pharmaceutical industry, global regulatory requirements, and product development processes throughout all life-cycle stages.

• Strong knowledge of the legal and regulatory landscapes 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.

• Ability to present technical COA concepts to cross-functional teams and senior stakeholders.

• Preferred: Master’s or Doctoral degree in a relevant field.

• Preferred: Experience supporting an NDA/BLA/MAA regulatory submission with COA content.

• Preferred: Prior presentations at conferences or publications in COA/PRO methodology.

• Preferred: Experience across various therapeutic areas.

🏝️ Benefits

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

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching program.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Incentive opportunities.