Associate Director, GHEOR Patient-Reported Outcomes Assessment (PROA), Cell Therapy
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Summary:
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 Responsibilities: 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
- 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
- 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
With a single vision as inspiring as Transforming patients' lives through science⢠, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected] . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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