Director, Clinical Outcome Assessments (COA) and Value & Real World Evidence (VRWE) Study Management

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 a Director, Clinical Outcome Assessments (COAs) & Global Study Management, you will be a champion of Otsuka’s culture and values and will be responsible for study management of strategic VRWE projects and collaborating with the Global Study Management, Health Technology Assessment (HTA) Operations & Clinical Outcome Assessments (COA) team within GVRWE. You will be accountable for enhancing value demonstration with innovative COA approaches and implementation within the Global Value & Real-World Evidence (GVRWE) organization. Additionally, this role will communicate the VRWE perspective and how it addresses corporate goals and strategies for pre-launch and on market medications. The Director, COAs & Global Study Management will contribute to relevant components of Clinical Development trials that address GVRWE considerations.

You will report to the Sr Director, Global Value & Real-World Evidence.

This position’s location is flexible, with our Princeton, NJ or Rockville, MD offices included in consideration. Otsuka maintains a hybrid work policy and travel is expected based on business needs.

Job Description

• Identification and validation of patient-reported outcome measures (PROMs) and Clinical Outcome Assessments (COAs; i.e., 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 (e.g., patient-relevant biomarkers or variables) in the context of label claims, regulatory submissions, health technology assessments (HTA), and generation of value evidence to support the relevance and meaningfulness from a patient (and/or caregiver) perspective per patient-focused drug development (PFDD) principles.
• For relevant Otsuka products, support the Medical Device Development Tool (MDDT) processes.
• Manage health authority requirements, developer guidance(s), scale licensing, copyright information, eCOA support, etc. for operational excellence at Otsuka.
• Subject matter expert on the execution and implementation of COAs in clinical trial programs, ensuring quality controls, data integrity, and alignment with cross-functional teams (Global Clinical Development, Clinical Management, Biostatistics, Statistical Programming, Strategic Sourcing & Execution, etc.).
• Qualitative (including determining concepts of interest, concept confirmation, cognitive debriefing, etc.) and quantitative (psychometric) research methods to determine measurement properties, responder and meaningful change definitions.
• Planning and 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
• Collaborate with Clinical Development/Clinical Management on licensing/translation/linguistic validation and modality adjustment/validation (eCOA/ePRO), measure implementation, as well as rater training development and implementation.
  
  

Minimum Qualifications

• 8+ 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.
• Comprehensive understanding of endpoint development to NDA/BLA/MAA.
• In-depth 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.
• Excellent knowledge of clinical development and research study designs and interpretation.
• In-depth 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.
• Strong 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.
  
  

#MS1

Annual Salary : Minimum $179,721.00 - Maximum $268,755.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

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.

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