The COAT is a newly formed team of experts in the measurement of subjective assessments focusing primarily on BMS’ oncology franchise. In addition to deriving a patient-centric understanding of relevant conditions, the team will play 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 will also a play a key role in disseminating the findings of patient-centric outcomes through scientific journals, regulatory dossiers, and press releases.
Example research activities may 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 the COAT in these areas. Provide strategic input at program and study levels and ensure team alignment. Ensure inputs reflect COA needs of multiple stakeholders, including (when relevant), regulators, payers, health care professionals, and patients.
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 COAT Lead’s initiatives and ensure alignment with objectives of the COAT.
Be an ambassador for the COAT and promote the importance of COAT’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 COAT 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>>.
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.
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.
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ...ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.