Director, Epidemiology

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Director Epidemiology is a member of the Global Epidemiology organization within Pharmacovigilance and Patient Safety (PPS). Major responsibilities include leading the epidemiology strategy and delivery for specific products in collaboration with other PPS and cross-functional team members. The epidemiology strategy encompasses (a) Pharmacoepidemiology studies to evaluate the safety, including PMR's and PASSs and other regulatory requirements; (b) epidemiologic analysis to support thorough signal evaluation and interpretation; (c) collaborative development of RMPs and Benefit-risk assessments (d) identification and determination of appropriate epidemiologic data sources to support decision making in the context of safety signals, (d) As a member of a cross-functional asset team, including Pharmaceutical Development, Medical Affairs, HEOR, and Statistics, contribute to product strategy and lead real-world data and evidence solutions to further understanding of the benefit-risk and evolving safety profile of drugs. This person is also responsible (indirectly or through direct oversight) for developing and leading more junior epidemiologists and overseeing statisticians/programmers. He or she must have an excellent understanding of data sources (e.g. claims and electronic medical record data sets) and epidemiologic analysis using such databases. This person maintains a high-level understanding of the US and international safety regulations and current regulatory safety review processes.

Under the direction of a Senior Director or the Department Head, the Director leads the conceptualization and execution of epidemiological evaluations of conditions, unmet need, and of drug or device safety. They contribute as a member of a team of epidemiologists who focus on meeting organizational goals within the scope of epidemiologic principles, patient safety, and public health. Promotes the use of state-of-the-art epidemiology methods within medical services and on cross-divisional teams when appropriate.

Responsibilities:

• Define epidemiologic strategy, vision, for an area or asset, and ensure delivery of high-quality pharmacoepidemiologic studies and evidence.
• Contribute as a subject matter expert through participation in cross-functional teams, committees (as assigned), and in response to internal stakeholder requests.
• Propose, design and oversee the execution of epidemiologic analyses to support knowledge gaps as needed (i.e.: background disease epidemiology, support signal evaluations, etc.)
• Ensure the delivery of relevant content for benefit-risk assessments, Risk Management Plans, and other safety and regulatory documents.
• Support product launches by strategic contribution to the assessment of the need for use of observational data, evaluation of data sources, design and conduct of observational studies

Functional Competencies:

• Business acumen: Knows how businesses work; knowledgeable in current and possible future policies, 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.
• Directing others: Is good at establishing clear directions; sets stretching objectives; distributes the workload appropriately; lays out work in a well-planned and organized manner; maintains two-way dialogue with others on work and results; brings out the best in people; is a clear communicator.
• Negotiating: Can negotiate skillfully in tough situations with both internal and external groups; can settle differences with minimum noise; can win concessions without damaging relationships; can be direct and forceful as well as diplomatic; gains trust quickly of other parties to the negotiations; has a good sense of timing.
• Building effective teams: Blends people into teams when needed; creates strong morale and spirit in his/her team; shares wins and successes; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates a feeling of belonging in the team.
• Financial acumen: Knows the financial implications of decisions regarding personnel, capital expenses, and vendor agreements.
• Priority setting: Assists the department Head, sets priorities for the Global Epidemiology group to efficiently accomplish goals.
• M aintains a high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.

Position can be hired as an Associate Director, Epidemiology or Director, Epidemiology based on the level of experience and education of the candidate.

Qualifications

Basic:

• Ph.D. Epidemiology or equivalent or MD/MPH or MD/MSc in epidemiology
• Minimum of 5 years of applied epidemiology or outcomes research experience.
• At least three years of experience in the pharmaceutical industry.
• Preference given to individuals with 1-2 years of line management experience. (optional)

Key Stakeholders:

The Director, Epidemiology is accountable to Global Epidemiology and PPS leadership. Other stakeholders are the product safety team (PST), Regulatory, and Pharmaceutical Development and Medical Affairs. The Director, Epidemiology is responsible for providing strategic solutions regarding pharmacoepidemiology study needs and requirements related to product safety, interpretation of complex epidemiologic studies on drug safety and reporting, and or initiating innovative methods of pharmacoepidemiology, particularly relevant to signal detection and benefit-risk assessment of medical products and devices.

T he Director Epidemiology is responsible for, (indirectly or through direct reporting), developing and leading more junior epidemiologists and providing guidance for statisticians/ programmers. He or she also understands the analysis of claims and electronic medical record data and maintains a high-level understanding of US and international safety regulations and current regulatory safety review processes.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 10 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.