Senior Director, Counsel, Diagnostics & Medical Devices (USA Remote Role)

Key Objectives/Deliverables

Provide strategic and solutions-oriented counseling to the Neuroscience Business Unit and other Lilly business units as assigned, on diagnostic and device issues related to their commercial strategy (e.g., lab-developed tests, in vitro diagnostics, imaging agents, medical devices, and software/digital health). Counsel business unit marketing, medical affairs, and related teams on commercial legal matters related to diagnostics, including FDA labeling and advertising requirements, the Anti-Kickback Statute and its safe harbors, the False Claims Act, antitrust, unfair competition law, consumer protection, data rights and privacy, FTC commercial law, and business transactions (including OUS), with particular depth in fraud and abuse, promotional, and antitrust matters.

Responsibilities

• Providing legal counsel and education on FDA labeling and promotional matters for diagnostic products and medical devices, as well as pharmaceuticals
• Providing diagnostics and device-related fraud and abuse, promotional, and antitrust counsel to the Neuroscience Business Unit and potentially across multiple business units
• Collaborating with sales and marketing colleagues to advise on device or diagnostic-related patient support and consumer programs consistent with healthcare fraud and abuse laws
• Educating business partners on potential legal implications of proposed marketing tactics related to diagnostics and medical devices
• Advising on potential legal implications related to interactions with third parties relevant to diagnostics and devices, including diagnostics companies and software/digital health companies
• Counseling on sponsored testing programs
• Participating as a core member of leadership teams responsible for diagnostics- and device-related brand and/or product strategies

Additional Skills and Expertise

• Deep knowledge and understanding of FDA laws and regulations pertaining to diagnostics and medical devices (e.g., Medical Device Amendments of 1976 to the FDCA, CLIA, state laws)
• Demonstrated knowledge of device and pharmaceutical marketing laws and regulations as generally practiced by innovative, multinational companies
• Demonstrated experience with fraud and abuse, promotional, and antitrust matters
• Experience evaluating sponsored testing programs for compliance
• Experience evaluating scientific communications and applying principles for communicating truthful and non-misleading scientific information
• Familiarity or experience supporting global marketing and commercialization of diagnostics or pharmaceuticals is a plus
• Ability to manage multiple priorities in a fast-paced and evolving environment
• Demonstrated ability to assess and help business colleagues manage risks in a highly regulated environment
• Sound judgment and issue-spotting ability
• Strong interpersonal skills and ability to partner well with others
• Committed to teamwork and collaboration
• 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
• Fluency in technology and appetite for applying technological solutions to simplify work and improve efficiency in the delivery of legal services