Overview
This role is for an Associate General Counsel within the R&D Innovation Legal group, supporting the research and development organization in navigating complex legal and regulatory issues related to pipeline development and product innovation. The position primarily focuses on Specialty and Aesthetics therapeutic areas and involves providing strategic legal counsel on long-term R&D and innovation strategies.
Responsibilities
- Provide strategic legal and regulatory counsel to senior R&D and corporate strategy leaders on issues impacting pipeline development and product innovation, including government pricing programs such as the Inflation Reduction Act.
- Serve as an embedded member of disease area strategy teams within Specialty and Aesthetics, contributing to long-term R&D and innovation strategies with a focus on FDA and external regulatory considerations.
- Educate legal departments and business stakeholders on emerging laws, regulations, and industry trends affecting the portfolio.
- Identify and resolve highly complex legal issues by developing creative and alternative solutions.
- Collaborate across Intellectual Property, Transactions, and Innovation Legal teams to provide coordinated advice, especially in key growth areas.
- Proactively identify unmet needs and future legal challenges, proposing strategies to optimize outcomes.
- Advise senior executives including Vice Presidents, Presidents, and Officers, providing expert and trusted counsel.
Requirements
- Juris Doctor (J.D.) degree and admission to the bar in at least one U.S. state.
- Minimum of 8 years of relevant legal experience; 10+ years preferred. Experience may include work at nationally recognized law firms with a life sciences focus, in-house pharmaceutical legal practice, or as an attorney for the FDA.
- Substantial expertise in FDA regulations and guidance related to innovator drug development, including clinical trial design, regulatory exclusivities, orphan drug designations, and combination products.
- Familiarity with policies that advance innovation in the pharmaceutical industry.
- Experience working with or interacting with government health authorities is highly desirable.
- Knowledge of the Inflation Reduction Act and its impact on drug development strategies is a plus.
- Strong understanding of pharmaceutical laws and regulations to assist business clients in a highly regulated environment.
- Demonstrated ability to work independently and lead cross-functional teams collaboratively.
- Ability to manage multiple priorities and adapt to a changing environment.
- Excellent executive presentation skills, capable of conveying complex information clearly and concisely to senior leadership.
- Must be able to work onsite at least three days per week at either the North Chicago, IL or Irvine, CA office locations.
Compensation & Benefits
- The base pay range for this role varies by geographic location and other factors; compensation will be determined accordingly.
- Comprehensive benefits package including paid time off (vacation, holidays, sick leave), medical, dental, vision insurance, and 401(k) plan eligibility.
- Eligibility to participate in short-term incentive programs.
Location
- Position requires presence in the office at least three days per week at one of the following locations:
- Abbott Park, North Chicago, IL
- Irvine, CA campus
The organization is an equal opportunity employer committed to integrity and innovation. Reasonable accommodations are available for applicants with disabilities.