Medical and Regulatory Affairs
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
PROA consists of a team of experts in the measurement of subjective assessments focusing on BMS’ oncology and innovative medicines franchises. In addition to deriving a patient-centric understanding of relevant conditions, the team plays a key role in measuring, analyzing, and interpreting relevant concepts in a scientifically robust manner using COA measures. The primary focus is on developing, assessing, using, interpreting, and disseminating patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (ClinROs) to derive treatment benefit during the clinical development of new medicines (Phase 2-4). The team also plays a key role in disseminating the findings of patient-centric outcomes through scientific journals, regulatory dossiers, and press releases.Example research activities include development of conceptual models of disease through literature reviews, expert clinician interviews, and concept elicitation interviews with patients; the systematic selection of COA instruments to measure specific concepts of interest; psychometric assessment of the measurement properties of COA instruments (e.g., reliability, validity, responsiveness); development of novel COA instruments, including the execution of cognitive interviews to ensure content validity; development of briefing books or dossiers for regulatory consideration of COAs for inclusion in product labeling; analysis of textual data from COAs or social media; and faithful migration of COA instruments from paper for electronic use.Internal customers include global clinical research, global biometric sciences, medical affairs, WWHEOR, Worldwide Value Access and Pricing, and Worldwide Commercial. In order to meet the needs of the business units and the multifunctional customer base, BMS is seeking outstanding COA scientists to support PROA in these areas.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required.
- Responsible for ensuring the implementation of optimal COA strategy in relevant protocols. This includes managing research required to support the selection, development, and validation of COA measures, including qualitative research. Provide protocol language, analysis plans, and guides for interpretation of findings.
- Maximize the impact of evidence of treatment benefit by providing input to briefing packages, publication strategies, and market access strategy
- Support PROA Lead’s initiatives and ensure alignment with objectives of the PROA team
- Be an ambassador for PROA and promote the importance of PROA’s role to quantitative and qualitative COA across BMS
- 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
- Prepare abstracts and manuscripts presenting COA results from clinical trials as well as COA development and validation studies that are aligned with publication strategy
- At direction of the PROA Lead, participate in global external collaborations regarding policies, standards, and use of COA measures (e.g., PRO Consortium, BIO PFDD Task Force, PRO-CTCAE working group, EuroQol Group, ISPOR working groups)
- Participate in creating and delivering education on COA measures for internal business partners
- Assist operations staff in securing licenses and commissioning translations/adaptations for COA instruments in a timely manner
- 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 7 years of related experience, including a minimum of 5 years of pharmaceutical industry or CRO experience
- Experience with application of COA measures in immunoscience, cardiovascular, and fibrotic diseases
- Experienced with COA requirements for regulatory and HTA/reimbursement agencies, including understanding of the FDA Patient Reported Outcomes Guidance
- Strong record of publication in COA
- 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
- Knowledge of the drug development process with oncology experience being strongly preferred
- Strong analytical and synthesis skills with regard to qualitative and quantitative data
- Excellent interpersonal and communication skills, both written and oral. Ability to understand and communicate with representatives from the range of disciplines
- Ability to manage multiple priorities and projects as well as balance workload and timelines. Able to work in a fast-paced and dynamic environment
- Ability to work effectively in small teams or independently
- Ability to interact with and manage internal and external networks
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 the resources to pursue their goals, both at work and in their personal lives.