Sr. Director - Counsel, Cell & Gene Therapy

Role Summary

Sr. Director - Counsel, Cell & Gene Therapy at Lilly. Deliver strategic and solutions-oriented legal counsel to multidisciplinary teams supporting expanding cell and gene therapy portfolios, spanning from early-stage research through post-market activities. Provide regulatory, commercial, and transactional support across the complete product development and commercialization continuum.

Responsibilities

• Deliver strategic legal counsel to multidisciplinary teams supporting cell and gene therapy portfolios.
• Advance novel genetic medicine programs targeting therapeutic areas with unmet medical needs while supporting the full product development and commercialization continuum.
• Guide complex regulatory, commercial, and transactional matters from early-stage research through post-market activities.
• Collaborate with internal legal teams and business stakeholders to navigate evolving regulatory and commercial frameworks for advanced therapies.
• Support new assets (therapeutics or diagnostics) as needed to grow Neuroscience and Cell & Gene Therapy portfolios.
• Act as an enterprise resource connector, coordinating with diverse collaborators across legal and business to achieve strategic objectives.

Qualifications

• Bachelor‚Äôs and Juris Doctorate Degree
• Licensed to practice law in at least one state
• 7‚Äì10 years of relevant legal experience in law firms, in-house at a pharmaceutical/biotechnology company, or a combination
• Authorized to work in the United States on a full-time basis (no visa sponsorship provided)

Additional Requirements

• Candidates based in or willing to relocate to Boston, MA or Indianapolis, IN highly advantageous
• Experience with global product development, registration, commercialization; FDA labeling and advertising requirements; various U.S. and global anti-fraud and competition laws; data rights and privacy; and commercial transactions
• Substantial experience counseling on genetic medicine-specific legal challenges, including regulatory submissions, manufacturing/distribution, and commercial launch considerations for cell and gene therapy products
• Strong ability to manage multiple priorities in a dynamic environment; risk assessment and issue spotting
• Excellent oral and written communication skills; ability to influence at all levels of management
• Strong teamwork, interpersonal skills, and attention to detail

Education

• Attorney with Juris Doctorate required
• Bar admission in applicable jurisdiction

Skills

• Strategic legal counsel for complex regulatory and commercial matters
• Regulatory affairs knowledge across cell and gene therapies
• Cross-functional collaboration with business units and legal teams
• Risk assessment and issue spotting in a heavily regulated environment
• Strong communication and presentation abilities

Additional Information

• Some travel required (US and limited international)