AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
The Associate Director, Epidemiology is a leader and technical expert in the Global Epidemiology group in Pharmacovigilance & Patient Safety. This person will contribute to the design and execution of pharmacoepidemiologic studies, provide data and insights to safety and other teams and contribute to scientific and departmental strategy. Some key areas of contribution expected for the Associate Director include: (a)proposing strategic solutions regarding pharmacoepidemiology study needs and requirements; (b) chipping in to the development of pharmacoepidemiologic safety outcomes studies and overseeing study execution ; (c) characterizing descriptive epidemiology of diseases and indications (d) contributing to regulatory submissions and responses; (d) contributing to risk management plans and other safety deliverables; (e) communicating study design and results effectively to diverse internal and external partners. He or she has and maintains an excellent understanding of epidemiologic data sources and methods and applies them to address program needs.
Lead projects with oversight from a senior epidemiologist, communicate results and be an effective member of cross-functional teams.
Evaluate, synthesize and communicate the epidemiology literature on any topic in both written and presentation formats.
Lead or contribute to the development of new evidence through study design, protocol development, and statistical analysis plans.
Support study start up and collaboration logistics including funding discussions, budget, contract and compliance processes.
Contribute to the design of registries and other primary data collection studies.
Lead all aspects of study analyses from secondary sources such as administrative claims or health record data, as needed.
Provide strategic epidemiologic support with oversight, to the PSTs and cross-functional teams and collaborate with Clinical Development, Medical Affairs, HEOR and Statistics, and others to achieve team goals.
Contribute and develop content for sections of risk management plans, benefit risk assessments, safety and regulatory deliverables.
Understands current and future polices, practices, trends, developments in information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
Negotiates with both internal and external organizations; can settle differences and win concessions without damaging relationships; can be direct as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
Maintains high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.
Understands the role of epidemiology in signal evaluation and where epidemiology contributes to key safety and regulatory deliverables.
MPH or MS with more than 7 years of experience or MD/PharmD/PhD with 2 or more years of experience in the field of epidemiology, outcomes research or related discipline.
Preference given to individuals with industry experience