Senior Director, Counsel, Diagnostics & Medical Devices

Location: US: USA Remote

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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).

This attorney will 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.

Depending on the business unit and programs assigned, additional subject matter may include laws and regulations pertaining to pharmaceutical promotion and other medical device and digital health matters.

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.

Responsibilities

Activities in this role may include the following

• 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, as assigned
• 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

Basic Requirements

Bachelor's degree and JD.

Licensed to practice law in at least one of the 50 States

Minimum of 7 years of relevant legal experience, practicing as a member of a law firm with a nationally recognized practice in medical devices and in vitro diagnostics, in-house at a medical device, laboratory or diagnostics company law department, in-house in a pharmaceutical or biotechnology company's law department, or a combination of the foregoing. In-house experience is preferred.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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

Other Information

Some travel required (circa 10% - US and possibly limited international).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$199,500 - $321,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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Additional Locations: US, Indianapolis IN