Associate Director, Epidemiology - Immunology (Remote)

Company Description

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. Follow @abbvie on X, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

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. 

Qualifications

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 exp