Associate Director, Nir Study Scientist

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

**Functional Area Description**

WWPS/Epi designs and conducts scientifically rigorous, observational research in support of the benefit/risk assessment of BMS products, both approved and under development. This includes assessment of adverse events associated with specific drugs and drug classes, as well as the evaluation of the usual course of specific diseases, their background rates and the comorbid conditions associated with standard of care. WWPS/Epi builds collaborations with matrix teams throughout drug development and life cycle management to provide contextualization of adverse events reported in association with specific BMS drug use in support of understanding the overall benefit/risk of BMS drugs and their risk management.

**Position Summary**

The Associate Director, NIR Study Scientist is a scientific, regulatory and operational role within WWPS/Epidemiology whose key function is to ensure the scientific strategy developed by the epidemiologists in support of drug development and life cycle management is successfully executed.

**Position Responsibilities**
- Actively executes the vision and operational model for the pharmacoepidemiology group and translates these to high quality pharmacoepidemiology activities
- Executes the scientific strategy defined by the epidemiologist, in support of protocol development, study approval and conduct, regulatory documentation and correspondence, etc.
- Supports the SMTs in their evaluation of safety signals and benefit-risk profiles of drugs, by helping to execute the scientific strategy developed with the epidemiologist
- Fosters communication between the Epidemiologist and internal/external stakeholders to facilitate study design and execution
- Manages day to day activities required for successful epidemiology studies
- Provides expert input on BMS processes for NIR and operationalization of epidemiology studies
- Provides regulatory expertise related to PASS and FDA PMR safety studies
- Supports various continuous improvement activities in the science and practice of pharmacoepidemiology to better support health care providers, regulatory requests, and the health of patients using BMS products
- Assures compliance with good pharmacoepidemiology and BMS business practices, regulatory and legal requirements
- May represent BMS Epidemiology in various external organizations and professional societies

**Degree / Experience Requirements**
- Scientific/biomedical degree (e.g., BS, MPH, RN, PharmD, PhD, MD) with relevance to clinical medicine, drug development, pharmacy/pharmacology, etc., or other degree with relevant educational certificate(s).
- Minimum total of 4 years of relevant experience, including at least 1 year of working with the pharmaceutical industry or a CRO.
- At least 2 years total of hands-on experience in drug safety, clinical research, medical affairs, regulatory science, and/or pharma study operations or any other function needed to support epidemiology study and non-study work.

**Key Competency Requirements**
- Experience in the design, development, conduct and interpretation of noninterventional in close collaboration with functions as needed (e.g., GDO, Medical, Regulatory, Biostatistics, Clinical Operations, Local Markets)
- Understanding of general principles of drug safety
- Understanding of the drug development and life cycle management processes
- General understanding of FDA, EMA, and PMDA regulatory requirements associated with the conduct and reporting of epidemiology analyses and independent studies (e.g., PASS, PMR, PMSS)
- Demonstrated project management and organizational skills
- Understanding of electronic quality, compliance and CTMS systems
- Ability to multitask and prioritize projects appropriately. Ability to influence matrix teams
- Good written and oral communication skills, especially for regulatory correspondence

**Travel Required**

Business travel for key congresses, regulatory meetings, and various internal/external engagements is required (5%)

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.