AbbVie
Director, Epidemiology - Immunology (Remote)
AbbVie, North Chicago, Illinois, us, 60086
Director, Epidemiology - Immunology (Remote)
Full-time
Salary Min: 172000
Salary Max: 326500
Therapy Area: Immunology
Area of Interest: Analytical Research & Development
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 at
www.abbvie.com .
Under the direction of the Immunology Therapeutic Area (TA) Head in Global Epidemiology, the Director serves as the Epidemiology Asset Strategy Lead for 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.
As the Global Epidemiology Asset Strategy Lead, 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 (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) 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.
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.
Required Qualifications:
PhD or MD/PhD in epidemiology or related discipline.
Minimum of 5 years (Director I) to 6 years (Director II) of experience in the conduct of epidemiological studies and/or using observational (real-world) data sources.
At least 3 years (Director I) to 4 years (Director II) in the pharmaceutical industry (pharmacoepidemiology/outcomes research).
Level of the role will be determined based on candidate experience level.
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.
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.
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Full-time
Salary Min: 172000
Salary Max: 326500
Therapy Area: Immunology
Area of Interest: Analytical Research & Development
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 at
www.abbvie.com .
Under the direction of the Immunology Therapeutic Area (TA) Head in Global Epidemiology, the Director serves as the Epidemiology Asset Strategy Lead for 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.
As the Global Epidemiology Asset Strategy Lead, 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 (Development, Safety, Regulatory Affairs, HEOR, Medical Affairs, Precision/Molecular Medicine, and Genetics Research Center) 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.
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.
Required Qualifications:
PhD or MD/PhD in epidemiology or related discipline.
Minimum of 5 years (Director I) to 6 years (Director II) of experience in the conduct of epidemiological studies and/or using observational (real-world) data sources.
At least 3 years (Director I) to 4 years (Director II) in the pharmaceutical industry (pharmacoepidemiology/outcomes research).
Level of the role will be determined based on candidate experience level.
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.
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.
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