Senior COA Strategy Lead

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Tuition reimbursement

Paid holidays and paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd. is seeking an Associate Director, COA to develop and execute COA strategy for one or more clinical programs, with oversight from Director level as needed.

You will interact with Global Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to ensure patient-centric endpoints align with target product profiles. The role requires leading COA evidence generation, contributing to regulatory dossiers, coordinating translation and training, and

Qualifications

• Bachelor's degree in outcomes research, health services research, epidemiology, psychology, public health, or a related field.
• 7+ years of COA/PRO experience, with at least 5 years in 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 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.

Responsibilities

• Identify fit-for-purpose COAs (PRO, ClinRO, ObsRO, PerfO) for assigned programs, in the context of label claims, regulatory submissions, and value evidence needs.
• 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.

Skills

COA/PRO experience

Evidence generation

Regulatory knowledge

Cross-functional collaboration

Communication skills

Project leadership

Independent COA design

Education

Bachelor’s degree in related field

Job description

Otsuka Pharmaceutical Co., Ltd. is seeking an Associate Director, COA to develop and execute COA strategy for one or more clinical programs, with oversight from Director level as needed.

You will interact with Global Clinical Development, Regulatory Affairs, Biostatistics, and Medical Affairs to ensure patient-centric endpoints align with target product profiles. The role requires leading COA evidence generation, contributing to regulatory dossiers, coordinating translation and training, and