Director, Epidemiology
Core
Leads epidemiology project leadership and strategic input for benefit-risk assessment of biopharmaceutical products in AbbVie's immunology portfolio, utilizing real-world data sources.
Role type
Director, Epidemiology (Strategic IC)
Builds
Regulatory-grade real-world evidence (RWE) and scientific publications supporting asset development.
Domain
Biopharmaceuticals / Immunology / Pharmacoepidemiology
Required skills
Epidemiology study design, Real-world data (RWD) analysis, Benefit-risk assessment, Regulatory science, Health authority regulations, Scientific communication, Protocol development, Data source evaluation
Preferred skills
Immunology therapeutic area expertise, Strategic plan development for observational studies, Regulatory and safety policy contribution
Technologies
RWD sources, Regulatory submission documents (ODDs, CSRs, RMPs, DSURs, PSURs, PSPs, PIPs)
Responsibilities
Develop and execute RWE strategy plans for assets, Collaborate with cross-functional partners (Clinical, Safety, Regulatory, HEOR), Lead research planning and non-interventional study execution, Represent company position to regulatory authorities, Evaluate data sources for RWE generation, Author scientific communications and regulatory submission sections
Seniority
Director, strategic leadership & cross-functional alignment