Clinical data coordinator h1.location_city

Job Summary:

The Director of Patient Experience Data and Clinical Outcome Assessments (PED&COA) leads the strategic integration of patient-centered outcomes into assigned global assets and programs. This role encompasses early development, regulatory submissions, post-marketing studies, and life-cycle management, ensuring patient perspectives are embedded throughout the drug development process.

As a key member of the Global Integrated Evidence & Innovation team, the Director (PED&COA) will develop and execute a scientifically rigorous, patient-focused global strategy for Patient-Centered Outcomes Research (PCOR). This role ensures alignment with FDA guidance on patient-focused drug development (PFDD), regulatory expectations, and health technology assessment (HTA) requirements, while advancing Otsuka's commitment to create innovative, high-quality products for better health worldwide.

Job Description:

Patient-Centered Outcomes Research (PCOR):

• High-level accountability for the patient-centric outcomes endpoint strategy, ensuring alignment with clinical development plans, protocols, analysis plans, clinical study reports, labeling discussions, and briefing packages.

• Assess and deliver guidance on disease/therapeutic areas and early projects requiring COA endpoints or components (e.g., patient/caregiver diaries) to support primary/secondary endpoints and patient experience assessments.

• Investigate the availability, fit-for-purpose status, and regulatory precedence of COA endpoints to meet project needs and support product target label claims and value evidence requirements.

Regulatory and Market Access Strategy:

• Provide guidance for interactions with payers and regulators regarding patient-centered outcomes, including early scientific advice, HTA consultations, and marketing authorization defense.

• Coordinate a global strategy and delivery of COA evidence packages/dossiers to secure marketing authorization, label enhancement, and access/reimbursement success.

• Evaluate and address COA- and patient-experience-related questions/requests from health authorities, including the development of supportive reports, evidence dossiers, and responses to in-trial and exit interviews.

Measurement Science and Methodology Advancement:

• Design and oversee the generation of COA evidence using qualitative and quantitative methods in line with international scientific standards and health authority guidance.

• Collaborate with clinical teams on licensing, translation, linguistic validation, and modality adjustments (e.g., eCOA/ePRO), as well as rater training development and implementation.

Strategic Leadership and Stakeholder Engagement:

• Build and maintain strong relationships with internal and external stakeholders across therapeutic areas to understand the evolving context of Otsuka's portfolio and support strategic approaches to drug development.

• Align with other patient-focused groups within Otsuka to identify synergies, foster collaboration, and facilitate knowledge sharing.

External Representation and Thought Leadership:

• Represent Otsuka in external forums and initiatives (e.g., C-Path, Duke Margolis, ISOQOL, ISPOR) to advance patient-centric outcomes and increase the success of Otsuka's portfolio.

• Contribute to the development and revision of guidance documents issued by external bodies (e.g., FDA, EMA, HTA organizations).

Additional Responsibilities:

• Provide input on the target product profile development and clinical development strategy from a COA and patient-centricity perspective.

• Translate COA data into actionable insights to support regulatory approval, access, and reimbursement for assigned clinical programs.

• Lead the development of COA evidence strategies across the product lifecycle, ensuring alignment with regulatory and market access requirements.

Cross-Functional Collaboration:

• Represent the COA function and manage effective communication with internal global/regional teams and external stakeholders.

• Collaborate with Clinical Development/Clinical Management teams to identify fit-for-purpose trial endpoints, adapt legacy measures, and develop new measures to support target populations and label claims.

Qualifications/ Required

Knowledge/ Experience and Skills:

Key Competencies:

• At least 7 years demonstrated expertise in designing and validating COA tools, including qualitative and quantitative research methodologies.

• Strong knowledge of clinical development, regulatory requirements and HTA standards for COA and patient experience data.

• Ability to lead cross-functional teams and external collaborations to advance patient-focused drug development.

Preferred

• Project management experience

Educational Qualifications

• Master's degree in a relevant field (outcomes research, health services research, epidemiology, public health, community health, or related fields)

• Doctoral degree in a relevant field

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 $186,489.00 - Maximum $278,875.00, 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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka .

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 Accommodation Request (EEAccommodations@otsuka-us.com) .

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