Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

As an Associate Director, Patient Centered Research & Clinical Outcome Assessments (COAs), you will be a champion of Otsuka's culture and values, and will be responsible for study management of prioritized VRWE projects and collaboration with the Global Study Management, Health Technology Assessment (HTA) Operations & Clinical Outcome Assessments (COA) team within GVRWE. You will be accountable for evidence generation and communication throughout the product lifecycle and will contribute to relevant components of Clinical Development trials that address GVRWE considerations. You will report to the Senior Director, Global Study Management, Health Technology Assessment (HTA) operations, & Clinical Outcome Assessments (COAs).

This position reports to the Senior Director, Global Study Management, Health Technology Assessment (HTA) Operations, & Clinical Outcome Assessments (COAs) and can be based in Rockville, MD, Princeton, NJ, or Aliso Viejo, CA. Otsuka maintains a hybrid work policy and travel is expected 30-50% of the time based on the location of the employee and as it relates to conference attendance and meetings. Remote option will also be considered for this position.

The Associate Director, Patient Centered Research & Clinical Outcome Assessments (COAs) will be comfortable with change in a high-paced environment and able to work in times of uncertainty, with less than complete information. Responsibilities will include:

Support identification and validation of patient-reported outcome measures (PROMs) and Clinical Outcome Assessments (COAs; ie, patient-reported outcome [PRO], clinician-reported outcome [ClinRO}, observer-reported outcome [ObsRO], performance outcome [PerfO], digital health technologies [TechRO]) as well as other patient-centered outcomes (eg, patient-relevant biomarkers or variables) in the context of label claims, regulatory submissions, health technology assessments (HTA).
Participate in generation of value evidence to support the relevance and meaningfulness from a patient (and/or caregiver) perspective per patient-focused drug development (PFDD) principles.
Assist in coordination of scale licensing, copyright information and eCOA support, for operational excellence at Otsuka.
Conduct qualitative research projects (including determining concepts of interest, concept confirmation, cognitive debriefing, etc) and quantitative (psychometric) research projects to determine measurement properties, responder and meaningful change definitions, coordinating with the COA team.
Execution of prioritized GVRWE projects, including prospective and retrospective observational studies, early disease modeling, and other VRWE activities.
Presentation and representation in external forums and initiatives relevant to patient-centric outcomes research and VRWE studies.

Job Description:

Build strong relationships with internal and external key stakeholders for therapeutic areas of interest to understand the evolving context of the Otsuka portfolio and effective implementation of COAs in selected programs.
Support interactions with payers and regulators regarding patient-centered outcomes as part of early scientific/HTA advice, and marketing authorization defense.
Collaborate with other patient-focused groups with Otsuka to support key synergies and areas for collaboration, information, and knowledge sharing.
Contribute to development and revision of guidances and other similar documents when issued by external bodies (eg, FDA, EMA, HTA bodies, etc).
Participate in key external initiatives related to patient-centric outcomes that increase the success of Otsuka's portfolio (eg, C-Path, Duke Margolis, ISOQOL, ISPOR).
Understand and communicate how COA data can help support regulatory approval success, as well as access and reimbursement for assigned clinical programs.
Support development of COA evidence packages/dossiers for submission to Health Authorities in securing marketing authorization, label enhancement as well as participate in, and support interactions with these authorities and decision makers.
Investigate to what extent COA endpoints are available, fit-for-purpose, and the degree of precedence of their use with regulatory authorities, in addition to meeting Otsuka project needs in support of the product target label claim and value evidence needs.
Work with clinical development teams to identify appropriate fit-for-purpose trial endpoints and/or to understand when new measures should be developed, or when legacy measures should be adapted and validated to support the desired target population and target label claim.
Support the generation of COA evidence (qualitative/quantitative methods) in line with international scientific standards and health authority guidance/regulations, in the context of COA tool development and validation to achieve "fitness for use" to inform the endpoint model of pivotal clinical trials in support of a label claim and for observational studies.
Support COA- and patient-experience-related questions/requests from regulatory authorities, including development of supportive reports and evidence dossiers.
Study management of VRWE projects and tactics for pre-launch and marketed products.
Represent the COA expert function and manage effective communications with various internal global/regional teams, as well as appropriate external forums and meetings.
Represent GVRWE on cross-functional internal teams for issues relating to patient-centered outcomes.

Minimum Qualifications:

Required

Doctoral or Master's degree in a relevant field (outcomes research, health services research, epidemiology, public health, community health, or related fields).
3+ years professional experience in the pharmaceutical industry, including experience launching products, HEOR and COA research techniques.
Knowledge of HEOR study design and conduct using real world data to generate evidence.
Understanding of endpoint development to NDA/BLA/MAA.
Knowledge of PCOR related international regulations, guidelines, and their application.
Experience with managing COA development and validation projects.
Technical competency in the use of eCOA/ePRO and its implementation, and linguistic validation of COA measures as well as an understanding of psychometrics and related statistics.
Knowledge of clinical development and research study designs and interpretation.
Understanding of qualitative and quantitative approaches applicable to patient insights.
Professional or expert knowledge of COA frameworks and its application to pharmaceutical development at an international level.
Knowledge of international healthcare systems and their changing needs for COA information.
Knowledge of legal and regulatory environment influencing clinical development plans, labeling, and promotional claims.

Preferred Knowledge, Skills, and Abilities:

Project management experience

Our Benefits:

Comprehensive medical, dental, vision and prescription drug coverage
Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance
Tuition reimbursement
401(k) match
PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits

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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.

Come discover more about Otsuka and our benefit offerings;

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.

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