Associate Director, Clinical Outcome Assessment

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

Role Summary

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 Global Clinical Development, Clinical Management, Regulatory Affairs, Biostatistics, Value Evidence, Global Medical Affairs, Pharmacovigilance, Patient Advocacy & Stakeholder Management 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, in the context of label claims, regulatory submissions, and value evidence needs.
• Apply qualitative methods (concept elicitation, concept confirmation, cognitive debriefing) and quantitative/psychometric methods to determine measurement properties, responder definitions, and meaningful-change.
• Investigate the extent to which COA endpoints are available, fit-for-purpose, and have regulatory precedent for assigned programs, in support of the product target label claim and value evidence needs.

Regulatory & evidence generation

• 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.

Cross-functional & external

• 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 (e.g., ISPOR, ISOQOL) as assigned.
• Build and maintain relationships with academic institutions, patient advocacy groups, clinical investigators, data vendors, and vendors relevant to assigned programs.

Required 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, with 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 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 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.

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; escalates cross-program or enterprise-level decisions to a Director.
• External representation: attends and increasingly presents at external scientific forums; not a primary Otsuka stakeholder for external interactions.

Competencies

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline

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

Company benefits:

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.