Associate Director, Regulatory Affairs
Allucent
Associate Director, GHEOR Patient-Reported Outcomes Assessment, Cell Therapy
Bristol Myers Squibb
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $180,830 - $219,122 per year
Job Level
Senior
About the role
- This position combines responsibilities of PROA and Health Outcomes Research Scientist roles. You will define and oversee the execution of clinical outcomes assessment (COA) strategies and implementations for the rigorous development and implementation of patient/clinician reported measures across Cell Therapy portfolio. Support the Executive Director in developing and executing health economic & outcomes research strategy across Cell Therapy assets PROA: Responsible for implementation of optimal COA strategy including managing research to support the selection, development and validation of COA measures across Cell Therapy portfolio in hematology, immunology and neuroscience therapeutic areas. Support eCOA design and implementation such as providing input to eCOA supplier contracting, kick-off and design meetings, and input in the development of company eCOA standards. Coordinate with functional counterparts in the development and review of eCOA documentation, including data model specifications, project plans, user acceptance testing scripts, device screenshots, site user guides and training slides, and data migration plans. Be an ambassador for PROA and promote the importance of PROA’s role to quantitative and qualitative COA across senior BMS leadership Prepare relevant sections of documents and communications for regulatory agency meetings, support and/or participate in said meetings at regulatory agencies, and provide robust evidence in support of submission activities. Support dissemination of COA results from clinical trials as well as COA development and validation studies that are aligned with publication strategy Participate in creating and delivering education on COA measures for internal business partners Health Economics and Outcomes Research: Support the development and execution of health economic & outcomes research strategies for CAR T assets throughout early development to post-launch lifecycle Assist in the implementation of HEOR studies and data dissemination activities, such as conducting systematic literature reviews, burden of illness analyses, real-world studies, economic modeling, patient-reported outcomes, and comparative effectiveness studies, as directed Collaborate closely with the Core Value Team to help advance Market Access & Pricing strategy and maintain alignment within the evidence generation plan for Market Access objectives Work as part of cross-functional teams—including clinical development, medical affairs, regulatory, and biostatistics—to ensure HEOR contributions are integrated into overall evidence generation plans Provide input to the management of the CAR T HEOR budgetary plan, helping to optimize the allocation and prioritization of HEOR resources in support of business objectives.
Requirements
- Preference will be given to candidates with a Ph.D. or equivalent degree in a relevant discipline (e.g., psychology, psychometrics, outcomes research, public health) or those who possess a clinical doctorate (M.D., Pharm.D.) coupled with a master’s degree The candidate should possess a minimum of 5 years of related experience, including a minimum of 3 years of pharmaceutical industry or CRO experience Experience conducting observational research involving PRO data collection and the interpretation and communication of results to key stakeholders Experienced with COA requirements for regulatory and HTA/reimbursement agencies, including understanding of the FDA Patient-Reported Outcomes Guidance Knowledge of development and validation of COA measures Understanding of health care markets and regulatory and reimbursement decision making, especially in relation to the global use of COA data Be abreast of rapidly changing methodological and regulatory environment with regard to COA Strong analytical and synthesis skills with regard to qualitative and quantitative data Demonstrated ability to understand and communicate with matrix teams to achieve the BMS’ vision of shaping the portfolio and securing and maintaining patient access #LI-Hybrid
