Senior Medical Director, Immunology, Global Patient Safety (Immunology)

Location: Onsite in North Chicago, Illinois, United States

Salary: $182,000–$346,000 per year

Company

AbbVie develops innovative medicines and solutions across therapeutic areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Lead patient safety strategy for assigned immunology indications across the product lifecycle.
• Oversee surveillance, signal detection, validation, assessment, and risk mitigation activities.
• Lead safety components of pre-NDA, NDA, and sNDA submissions, regulatory responses, labeling updates, RMPs, PSURs, DSURs, PADERs, and IB updates.
• Analyze aggregate safety data and communicate recommendations to cross-functional teams, executive leadership, and external stakeholders.
• Collaborate with clinical development, statistical science, epidemiology, regulatory, medical affairs, safety scientists, and safety architects.
• Coach and mentor colleagues while contributing to publications and initiatives that advance patient safety leadership.

Requirements

• MD or DO with at least 2 years of patient management experience.
• At least 5 years of pharmaceutical-industry patient safety experience, including leadership experience.
• Experience with marketing authorization submissions or other regulatory interactions.
• Previous pharmaceutical clinical development experience.
• Ability to analyze and guide analysis of clinical and epidemiological data, write and review technical documents, and present recommendations.
• Ability to lead cross-functional teams collaboratively in a fast-paced environment.

Nice to have

• Immunology or internal medicine experience.
• Experience with pharmaceutical, biological, or drug-device combination products.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.
• Opportunity to co-author publications and participate in professional development initiatives.