Job Description

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 functions RWE strategy plan for evidence that proactively supports assets in AbbVies 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 companys 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

No

Employment Type :

Full-time

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