[Hiring] Senior Director, Counsel, Diagnostics & Medical Devices @Lilly

Role Description

Senior Director, Counsel, Diagnostics & Medical Devices

• Provide strategic and solutions-oriented counseling to the Neuroscience Business Unit and other Lilly business units on diagnostic and device issues related to their commercial strategy.
• Counsel business unit marketing, medical affairs, and related teams on commercial legal matters related to diagnostics, including:
• FDA labeling and advertising requirements
• Anti-Kickback Statute and its safe harbors
• False Claims Act
• Antitrust
• Unfair competition law
• Consumer protection
• Data rights and privacy
• FTC commercial law
• Business transactions (including OUS)
• Work collaboratively with legal colleagues in other areas, business units, and affiliates.
• Provide practical counsel in a fast-paced, dynamic, and innovative environment.

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.
• 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.
• Counseling on sponsored testing programs.
• Participating as a core member of leadership teams responsible for diagnostics- and device-related brand and/or product strategies.

Qualifications

• 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.
• In-house experience is preferred.
• Qualified applicants must be authorized to work in the United States on a full-time basis.

Requirements

• Deep knowledge and understanding of FDA laws and regulations pertaining to diagnostics and medical devices.
• Demonstrated knowledge of device and pharmaceutical marketing laws and regulations.
• Experience with fraud and abuse, promotional, and antitrust matters.
• Experience evaluating sponsored testing programs for compliance.
• Ability to manage multiple priorities in a fast-paced and evolving environment.
• Strong interpersonal skills and ability to partner well with others.
• Excellent oral and written communication skills.
• Fluency in technology and appetite for applying technological solutions.

Benefits

• Anticipated wage for this position is $166,500 - $244,200.
• Eligibility for a company bonus based on performance.
• Comprehensive benefit program including:
• 401(k) and pension
• Vacation benefits
• 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
• Well-being benefits (e.g., employee assistance program, fitness benefits)