- Area of Interest: Analytical Research & Development
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onTwitter ,Facebook ,Instagram ,YouTube andLinkedIn .
Job Description
The Director (Epidemiology) is a member of the Global Epidemiology in Pharmacovigilance & Patient Safety, Epidemiology, R&D Quality Assurance (PSEQ). Major responsibilities include leading the scientific strategy and delivery of pharmaco-epidemiology/real-world evidence to inform product development and safety across all therapeutic areas in collaboration with other cross-functional team members. The real-world evidence generation strategy encompasses (a) regulatory required pharmacoepidemiology studies to evaluate product safety, including PMR’s and PASSs and other regulatory requirements; (b) real-world evidence generation to support product development and safety (across products and across therapeutic areas); (c) determination of appropriate epidemiologic data sources and methodology to support decisions throughout the lifecycle of products including post-marketing safety, (d) development of capabilities/methodology to bridge knowledge gaps. The Epidemiology Director provides expertise in regulatory pharmacoedemiology across functions. The Epidemiology Director is also responsible (indirectly or through direct oversight) for developing junior epidemiologists and overseeing data scientists and programmers as appropriate. They must have an excellent understanding of real-world data sources (e.g. claims and electronic medical record data sets) and regulatory pharmacoepidemiology/real-world study design, method, analysis, and interpreation. The Director has a solid understanding of the US and international safety regulations and standards and of current regulatory safety review processes.
Responsibilities:
Under the direction of a Senior Director or the Department Head, the Director leads the conceptualization, design, and execution of epidemiological evidence in response to regulatory requirements and evaluations of disease conditions 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.
Core Job Responsibilities:
- leads scientific strategy and ensure delivery of high-quality pharmacoepidemiologic, real-world studies and evidence.
- Contribute as a subject matter expert through participation in cross-functional teams, committees (as assigned), and in response to stakeholder requests.
- Propose, design and oversee the execution of epidemiologic analyses to support knowledge gaps as needed (i.e.:support signal evaluations, etc.)
- Ensure execution of regulatory-grade of relevant evidence to inform benefit-risk assessments, Risk Management Plans, and other safety and regulatory documents.
- 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.
Maintains a high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.
This role can be based anywhere in the United States or the UK.
Qualifications
- 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)
- MD preferred
Key Stakeholders: VP PPS, VP Epidemiology, TA Area Leads in PPS and Cross-Functional R&D partners
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
This job is eligible to participate in our short-term incentiveprograms.
This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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