Associate General Counsel, R&D Innovation Legal (Specialty & Aesthetics)

Role Summary

As an Associate General Counsel in the R&D Innovation Legal group, you will support AbbVie's R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. This individual is motivated by the opportunity to address and solve emerging issues with a strategic and creative business-oriented approach and provide expert counsel on decisions impacting our long-term pipeline strategies. This role will primarily be supporting our Specialty and Aesthetics therapeutic areas.

Responsibilities

• Develop and provide strategic counsel to senior R&D and corporate strategy leaders on legal regulatory issues that impact pipeline development and product innovation, including assessing the impact of government pricing programs (e.g. Inflation Reduction Act) on pipeline strategies. Assigned matters have significant impact to AbbVie overall.
• Embedded within the Specialty and Aesthetics therapeutic areas to contribute as a key member of disease area strategy teams responsible for long-term R&D and innovation strategies. Focus is on pipeline development and the FDA and external environment considerations when assessing strategic approaches. This is not a role focused on FDA advertising and promotional considerations or a role that evaluates patents or IP strategies.
• Educates other AbbVie legal departments and business stakeholders on emerging laws, regulations and industry trends impacting AbbVie portfolio.
• Proactively identifies highly complex legal issues related to assigned matters, develops creative and alternative solutions, and implements resolution. Works across our Intellectual Property, Transactions and Innovation Legal Department to provide coordinated IP and R&D strategic advice, particularly for key growth areas.
• Adopts a business oriented and creative approach to problem solving.
• Identifies unmet needs and future legal issues and proactively proposes strategies to optimize outcomes and results for the company.
• Advises Vice Presidents, Presidents and Officers. Recognized by these clients as both expert in substantive area and relied upon for individual advice.

Qualifications

• J.D. and currently admitted to the bar in at least one U.S. state.
• Minimum of 8+ years (10+ preferred) of relevant experience practicing as a member of a nationally recognized law firm in a life sciences practice, practicing in-house at a pharmaceutical company or practicing as an attorney for the FDA, or any combination of the above.
• Individual will have substantial expertise in FDA regulations and guidance around innovator drug development, including on clinical trial design and study requirements, regulatory exclusivities, orphan drug designations, and combination products, and have familiarity with policies to advance innovation in the industry.
• Experience working for, or having interactions with, government health authorities is highly desirable.
• Familiarity with the Inflation Reduction Act and impact on drug development strategies is a plus.
• Knowledge and understanding of pharmaceutical laws and regulations to help business clients assess issues in a highly regulated landscape.
• Demonstrated ability to work independently and lead cross-functional teams collaboratively.
• Ability to adapt to a changing environment while handling multiple priorities.
• Must have excellent executive presentation skills and be comfortable presenting complicated information accurately and concisely to senior leaders.

Additional Requirements

• In-office requirement: must be in the office at least 3 days per week at Abbott Park, North Chicago, IL or AbbVie’s campus in Irvine, CA.