Senior Director, Counsel, Diagnostics & Medical Devices

Eli Lilly and Company • Us, IN

3d • $199,500 - $321,200

About The Position

Lilly is seeking a Senior Director, Counsel, Diagnostics & Medical Devices to provide strategic, practical legal advice to the Neuroscience Business Unit and other business units as assigned. The attorney will advise on commercial strategies involving diagnostics and devices, including lab-developed tests, in vitro diagnostics, imaging agents, medical devices, and software or digital health. The role works closely with business-unit marketing, medical affairs, sales, and other teams, as well as legal colleagues, business units, and affiliates, in a fast-paced and evolving environment.

Counseling areas include FDA labeling and advertising, healthcare fraud and abuse laws, antitrust, unfair competition, consumer protection, data rights and privacy, FTC commercial law, and business transactions, including outside the United States. The position has particular depth in fraud and abuse, promotional, and antitrust matters. Depending on assignments, the attorney may also advise on pharmaceutical promotion and other medical-device and digital-health matters. Some travel is required, approximately 10% in the United States and possibly limited international travel.

Requirements

• Bachelor’s degree and JD.
• Licensed to practice law in at least one of the 50 states.
• At least 7 years of relevant legal experience practicing at a law firm with a nationally recognized medical-device and in vitro diagnostics practice, in-house at a medical device, laboratory, or diagnostics company, in-house in a pharmaceutical or biotechnology company, or a combination of these.
• Deep knowledge of FDA laws and regulations concerning diagnostics and medical devices, such as the Medical Device Amendments of 1976 to the FDCA, CLIA, and state laws.
• Knowledge of device and pharmaceutical marketing laws and regulations as practiced by innovative multinational companies.
• Experience with fraud and abuse, promotional, and antitrust matters.
• Ability to manage multiple priorities in a fast-paced, evolving environment.
• Ability to assess risks and help business colleagues manage them in a highly regulated environment.
• Sound judgment and issue-spotting ability.
• Strong interpersonal skills and ability to partner well with others.
• Commitment to teamwork and collaboration.
• Excellent oral and written communication skills, including the ability to present complex information accurately and concisely and influence people at all management levels.
• Fluency in technology and interest in applying technological solutions to simplify work and improve the efficiency of legal services.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor or support work authorization or visas for this role.

Nice To Haves

• In-house experience is preferred.
• Experience evaluating sponsored testing programs for compliance.
• Experience evaluating scientific communications and applying principles for communicating truthful and non-misleading scientific information.
• Familiarity with or experience supporting global marketing and commercialization of diagnostics or pharmaceuticals.

Responsibilities

• Provide strategic, solutions-oriented legal counsel to the Neuroscience Business Unit and other business units on diagnostic- and device-related commercial matters.
• Advise and educate on FDA labeling and promotional matters for diagnostic products, medical devices, and pharmaceuticals.
• Provide diagnostics- and device-related fraud and abuse, promotional, and antitrust counsel.
• Collaborate with sales and marketing colleagues on patient-support and consumer programs involving devices or diagnostics, ensuring consistency with healthcare fraud and abuse laws.
• Educate business partners about legal implications of proposed marketing tactics related to diagnostics and medical devices.
• Advise on legal implications of interactions with third parties relevant to diagnostics and devices, including diagnostics and software or digital-health companies.
• Counsel on sponsored testing programs.
• Participate as a core member of leadership teams responsible for diagnostic- and device-related brand and product strategies.
• Work collaboratively with legal colleagues, business units, and affiliates to provide practical advice in a dynamic environment.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior