Director, Epidemiology

BioSpace; North Chicago (IL); A distancia; USD 180.000 - 240.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a Director of Global Epidemiology to lead or support immunology portfolio assets, shaping RWE strategies and providing project leadership across the lifecycle of products. The role involves cross-functional collaboration with Clinical Development, Safety, Regulatory Affairs, HEOR and Medical Affairs to design, execute, and disseminate epidemiology studies and real-world evidence.

The position requires advanced degrees in epidemiology with industry experience, strong

Formación

• MD-PhD or PhD with 3+ years in industry; or MPH/MS with 10+ years in industry.
• Experience in Immunology therapeutic area strongly preferred.
• Independently develop and lead asset-focused epidemiology and real-world observational studies.
• Excellent oral and written communication with executive presence.

Responsabilidades

• Represent Global Epidemiology on cross-functional asset teams.
• Develop and execute the RWE strategy plan for immunology assets during the product lifecycle.
• Collaborate with Clinical Development, Safety, Regulatory Affairs, HEOR, Medical Affairs to plan and execute studies.
• Lead or manage staff in research planning and non-interventional study execution and publication.
• Interface with regulatory authorities for real-world evidence in regulatory filings.
• Evaluate data sources for RWE generation to address study questions in AbbVie immunology.
• Maintain knowledge of pharmacoepidemiologic methods and RWD/RWE applications.

Conocimientos

Executive communication

Strategic planning

Cross-functional collaboration

Leadership

Educación

MD-PhD or PhD in epidemiology/pharmacoepidemiology

MPH/MS in epidemiology/pharmacoepidemiology

Descripción del empleo

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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

• 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
• 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.

Additional Information

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.

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.

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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation,

https://www.abbvie.com/join-us/reasonable-accommodations.html