Associate Director, Epidemiology Strategist Princeton - NJ - US R1605527 Posted

Working with Us

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. Read more:

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.

The WWPS/ Epidemiology Associate Director, Epidemiology Strategy is a scientific and strategic leader within WWPS whose key role is to ensure:

• accurate understanding of the epidemiology of diseases of interest and specific drug indications within those diseases;
• scientifically valid approaches to contextualizing adverse events expected and reported in association with BMS drugs;
• appropriate support of regulatory activities required to obtain and maintain BMS drug approvals.

The role is as an individual contributor.

• Actively executes the vision and operational model for the pharmacoepidemiology group and translates these to high quality pharmacoepidemiology activities
• Communicates the scientific and strategic value of pharmacoepidemiology to assigned Safety Management Teams (SMTs)
• Conducts epidemiologic analyses and provides interpretation of their results in support of BMS drugs to SMTs and product development teams, among other stakeholders at BMS
• Under the direct supervision of a senior epidemiologist, creates the epidemiology strategy to support drug development, filings with regulatory agencies and maintenance of drug approvals in one or more therapeutic areas (TA)
• Works with scientists, members of the product teams, and other matrix partners to ensure the epidemiology strategy is correctly and efficiently executed
• Applies theoretical principles to specific clinical questions and research problems, develop innovative, but valid, pharmacoepidemiologic solutions to previously unknown methodologic challenges using real-world data
• Supports the SMTs in their evaluation of safety signals and benefit-risk profiles of drugs, by developing scientifically rigorous epi strategies while considering regulatory requirements and expectations
• 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

Education/ Experience/ Licenses/

Certifications:

• Master’s level, Ph.D. or equivalent degree in a relevant discipline (e.g., epidemiology, health service research, outcomes research, health economics) or other education and training that is considered similar and equivalent, especially if combined with another clinical or biologically based degree
• Minimum of 4 years of relevant experience, including at least 1 year of working with the pharmaceutical industry or a CRO
• At least 2 years of hands-on experience conducting epidemiology, pharmacoepidemiology, outcomes, health economics, health services, or health technology…