Associate Director, Epidemiology - Immunology (Remote) - 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 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 onX,Facebook,Instagram,YouTubeandLinkedIn.

The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the scientific strategy for pharmacoepidemiology and real-world evidence to support product development and safety across therapeutic areas. They design and interpret studies, contribute to regulatory submissions, and provide expertise in regulatory pharmacoepidemiology and real-world study methods.

Responsibilities:

1. Lead or contribute to the development of real-world evidence, including study design, protocol and statistical analysis plan development, and execution using various data sources, such as administrative claims and health records data.

2. Conduct comprehensive literature reviews to support signal assessments, establish background rates for disease states, and develop risk management plans; synthesize and communicate results in both written and presentation formats.

3. Deliver epidemiology content for core safety and regulatory documents, such as RMPs, BRPAs, ODAs, Briefing Books, and MSAs; lead and participate in vendor or collaborator selection and the creation of study-related materials.

4. Advance epidemiology research and methodologies, providing expertise on novel and existing techniques to address benefit-risk questions; establish key scientific partnerships to enhance real-world methodologies and capabilities.

5. Collaborate with global epidemiology teams and key partners, including Pharmaceutical Development, Medical Affairs, HEOR, and Statistics, to achieve team goals.

6.Development of RWE studies to support asset and disease area strategies, in collaboration with cross-functional partners in Clinical Development, Medical Affairs, HEOR and others.

This role can be remote in the US.

Educational Background: PhD/PharmD with 3-5 years of experience, or MPH/MS with a minimum of 5 years of experience in epidemiology, outcomes research, or a related discipline.

Technical Expertise: Demonstrated high level of methodology and technical expertise in regulatory real-world methods, data sources, and study design.

Communication Skills: Proven ability to clearly communicate epidemiology concepts, both verbally and in writing, to diverse audiences. Able to articulate study rationale, design, and expected impact on supported programs.

Business Acumen: Knowledgeable in current and future policies, practices, trends, and developments affecting the business and organization; understands regulatory pharmaco-epidemiology. Industry experience is preferred.

Negotiation Skills: Ability to negotiate skillfully in challenging situations with both internal and external groups, settle differences amicably, gain trust quickly, and effectively balance directness and diplomacy.

Regulatory Knowledge: Comprehensive understanding of methods for adverse event collection and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management processes. Knowledgeable of U.S. and international safety regulations and current regulatory safety review processes.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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

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 AbbVies 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 only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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

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 AbbVies 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 only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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