Director, Clinical Outcome Assessments (COA) and Value & Real World Evidence (VRWE) Study Management
Otsuka
- Princeton, NJ
- Permanent
- Full-time
- 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.
- 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.
- Project management experience
- 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.
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.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 .Statement Regarding Job Recruiting Fraud ScamsAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website .Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and ODH, 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.