Sr. Director - Counsel, Cell & Gene Therapy

Role Summary

Sr. Director - Counsel, Cell & Gene Therapy at Lilly. Delivers strategic and solutions-oriented legal counsel to multidisciplinary teams supporting expanding cell and gene therapy portfolios, guiding regulatory, commercial, and transactional matters across the product development and commercialization continuum.

Responsibilities

• You will deliver strategic and solutions-oriented counsel to multidisciplinary teams supporting our expanding cell and gene therapy portfolios, advancing novel genetic medicine programs, and providing legal support across the complete product development and commercialization continuum.
• Report to the Neuroscience, Diagnostics, and Cell & Gene Therapy general counsel as a member of the business unit legal team, with partnership with the Senior Vice President of Lilly Genetic Medicines.
• 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 support growth and expansion of Neuroscience and Cell & Gene Therapy portfolios.
• Act as an enterprise resource connector, bringing together a wide variety of collaborators across legal and business to accomplish strategic objectives.

Qualifications

• Bachelor’s and Juris Doctorate Degree
• Licensed to practice law in at least one of fifty states
• 7–10 years of relevant legal experience in law firm, in-house at a pharmaceutical/biotechnology company, or a combination
• Authorized to work in the United States on a full-time basis (no 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; anti-kickback statute and safe harbors; False Claims Act; antitrust; data rights and privacy; FTC commercial law; and business transactions
• Experience counseling on genetic medicine-specific legal challenges including regulatory submissions, manufacturing and distribution complexities, and launch considerations for cell and gene therapy
• Ability to manage multiple priorities in a dynamic environment; strong analytical, judgment, and issue-spotting skills
• Excellent oral and written communication; ability to influence at all management levels
• Strong interpersonal skills, teamwork, and collaboration
• Strong organizational skills and attention to detail

Skills

• Regulatory strategy for cell and gene therapies
• Cross-functional collaboration with business and legal teams
• Risk assessment and management in a highly regulated environment
• Complex contract negotiation and transaction support
• Regulatory submissions and post-market compliance

Education

• Bachelor’s degree
• Juris Doctorate

Additional Information

• Some travel required (US and limited international)