AbbVie

Director, Epidemiology

AbbVie • $150K — $180K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • MD-PhD or PhD in epidemiology or pharmacoepidemiology with 3+ years of industry experience, or MPH/MS with 10+ years
  • Experience in Immunology therapeutic area highly preferred
  • Strong background in developing strategic epidemiology plans
  • Excellent oral and written communication skills for cross-functional collaboration
  • Familiarity with regulatory and safety policy documentation

Responsibilities

  • Represent Global Epidemiology on cross-functional asset development teams
  • Develop and execute RWE strategy plans for project lifecycle support
  • Collaborate with various stakeholders to execute epidemiology studies
  • Lead research planning and non-interventional study execution
  • Communicate the company's stance on regulatory real-world evidence
  • Evaluate data sources for epidemiologic study questions
  • Maintain knowledge of pharmacoepidemiologic methods and health authority regulations
  • Author scientific communications and regulatory submission sections

Benefits

  • Medical, dental, and vision insurance
  • Paid time off including vacation and sick leave
  • 401(k) retirement plan
  • Participation in long-term incentive programs
Full Job Description
Under the direction of the Immunology Dermatology Lead in Global Epidemiology, the Director leads or supports one or more assets in the AbbVie immunology portfolio; provides epidemiology project leadership and strategic input to the benefit-risk assessment of biopharmaceutical products; leads epidemiology study design, including analysis of real-world data sources, independently or with additional support; interpretation of real-world evidence; and maintains an understanding of US and international health authority initiatives and regulations impacting the functions of regulatory science and pharmacovigilance, as applicable to RWD/RWE. Responsibilities: • Represent Global Epidemiology on cross-functional, matrix sub-teams of overall asset development teams. • Develop and execute the function's RWE strategy plan for evidence that proactively supports assets in AbbVie's immunology portfolio throughout the product lifecycle. • Collaborate with key stakeholders and cross-functional partners (Clinical Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine) to propose and execute on epidemiology and RWE studies that support key asset strategy needs. • Lead or manage other staff in the conduct of research planning and non-interventional study execution, including protocol and SAP development, cross-functional alignment, and delivery of final results/study report and peer-reviewed scientific publications. • Represent the company's position to regulatory authorities in written and verbal communications for regulatory-grade real-world evidence in support of company filings. • Evaluate potential data sources and their applicability (fit for purpose) for RWE generation to address different epidemiologic study questions of interest in support of AbbVie immunology drug development. • Maintain current knowledge of principled pharmacoepidemiologic methods, RWD sources and their applications to benefit-risk evaluation, as well as current health authority initiatives and regulations impacting the functions of pharmacovigilance and regulatory science as applicable to RWD/RWE. • Author and disseminate scientific communications and research articles via presentations at professional conferences and publication in the medical peer-reviewed literature. • Author or serve as internal departmental reviewer for relevant epidemiology sections of regulatory submissions - ODDs, CSRs, RMPs, DSURs, PSURs, PSPs, and PIPs. Qualifications Required Qualifications: • MD-PhD or PhD in epidemiology, pharmacoepidemiology, or a closely related discipline, with 3 or more years of industry experience; or • MPH/MS in epidemiology, pharmacoepidemiology, or a closely related discipline, with 10 or more years of industry experience Preferred Qualifications: • Epidemiology experience within Immunology therapeutic area strongly preferred • Experienced in independently developing and leading strategic plans for asset-focused epidemiology and real world observational studies • Excellent oral and written communication skills and executive presence in cross-functional settings • Experience with regulatory and safety policy and contributing to regulatory and safety documents preferred. Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required. Frequent to continuous computer usage (greater or equal to 50% of the workday) is required. This role can be based anywhere in the United States. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. • This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

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Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

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We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

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Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ

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