Associate Vice President, Assistant General Counsel

Key Objectives/Deliverables

Provide strategic and solutions-oriented counsel to a Lilly Business Unit as brand counsel for its product portfolio (therapeutic area(s) as assigned).

Counsel business unit teams — including marketing, medical affairs, product development, and communications — on various legal matters including, but not limited to, FDA labeling and advertising requirements, U.S. and global clinical development and regulatory submissions, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust and unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions.

Depending on the therapeutic area assigned, additional subject matter may include laws and regulations pertaining to sponsored testing, Medicare coverage and reimbursement dynamics, and device or digital health considerations.

In this role, this attorney will work collaboratively with legal colleagues in other areas, business units, and affiliates, and must be proactive and adept in providing practical counsel in a fast-paced, dynamic, and innovative environment.

The position will report to the applicable Business Unit General Counsel.

Responsibilities

• Provide legal counsel and education on FDA labeling and promotional matters
• Collaborate with sales and marketing colleagues to advise on patient support and other programs consistent with healthcare fraud and abuse laws
• Educate business partners on potential legal implications of proposed marketing programs
• Advising on potential legal implications related to interactions with third parties relevant to the assigned therapeutic area (e.g., diagnostics companies, digital health partners)
• Participating as a core member of leadership teams responsible for U.S. brands and/or global product strategies
• Drafting, reviewing, and advising on various contracts related to Lilly assets, including collaborative research agreements
• Advising on data disclosures following clinical development achievements via press release and U.S. and international medical congresses, consistent with applicable laws and regulations

Basic Requirements

• Bachelor's degree and JD degree from accredited schools
• Admitted to the bar in at least one of the fifty states; eligible to be admitted to the bar in Indiana under Indiana Admissions Rules
• Minimum of 10 years of relevant legal experience, with at least 4 years of experience in-house in a pharmaceutical or biotechnology company's law department

Additional Skills And Expertise

• Working knowledge and understanding of pharmaceutical marketing laws and regulations as generally practiced by innovative, multinational pharmaceutical manufacturers
• Experience with product counseling in the diabetes, obesity, cardiovascular, or oncology therapeutic areas
• Global mindset — familiarity or experience supporting global marketing and commercialization of pharmaceuticals worldwide or in jurisdictions outside the United States preferred
• Experience with clinical collaborations, the Anti-Kickback Statute, competition law, pricing, and reimbursement/access issues as they pertain to the pharmaceutical industry, including Medicare
• Experience evaluating scientific communications for integrity and context, and applying principles for communicating truthful and non-misleading scientific information
• Experience evaluating sponsored testing programs for compliance
• Demonstrated ability to assess and help business colleagues manage risk in a highly regulated environment
• Excellent oral and written communication skills, with a demonstrated ability to present complex information accurately and concisely to influence others at all levels of management, including C-suite executives
• Excellent analytical and organizational skills
• Sound judgment and issue-spotting ability
• Demonstrated learning agility and curiosity
• Strong interpersonal skills and ability to partner well with others
• Committed to teamwork and collaboration, both within Legal and with business partners
• Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency in the delivery of legal services
• Demonstrated ability to proactively identify opportunities for creative and innovative solutions