Senior Director - Counsel, Clinical Development, Regulatory Legal

Lilly • Indianapolis, IN

5d • Remote

About The Position

The Senior Director - Counsel, Clinical Development will be part of the Regulatory Legal Team (RLT), which is a core partner to the business, providing regulatory legal counsel across the product lifecycle from development through registration, commercialization, and post-market activities. RLT is a collaborative team of lawyers who collectively maintain the legal expertise for the Company on global regulatory laws, including for clinical development and registration, manufacturing and quality, patient safety, environmental and other areas of law. RLT works in close coordination with Business Unit Legal Teams (BULT), International Business Unit Legal (IBU Legal), IP, Litigation and other legal and risk functions to deliver cohesive, forward-looking guidance that enables innovation while leading legal and regulatory risk.

Requirements

• Bachelor’s Degree and a Doctor of Jurisprudence (J.D.).
• Licensed to practice law in one of the 50 states in the USA.
• Minimum of 5 -10 years experience as an in house lawyer in a law firm or industry (pharmaceutical or device).
• 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 and 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.

Nice To Haves

• Ability to triage, prioritize and efficiently counsel a high volume of inputs from a variety of sources
• Highly motivated and collaborative partner with strong communication skills and the ability to work efficiently with team members, lawyers, and members of management across all levels of the Company
• Excellent judgment and meticulous level of attention to detail
• Excellent written and verbal communication skills with an ability to influence others, including leadership
• Shown ability to appropriately handle highly confidential information
• Confirmed dedication to expand knowledge and adapt to a changing, rapid-paced environment
• Shown leadership and efficiency in working with senior leadership
• Prior regulatory agency experience.

Responsibilities

• Provide strategic, solutions-oriented legal counsel and regulatory and Good Clinical Practice (GCP) expertise in support of Lilly’s clinical development programs in the U.S. and globally, with a particular focus on close partnership with the Clinical Capabilities - Portfolio Management and Clinical Delivery team.
• Help enable modernization of clinical trials through AI, automation, and scalable processes and governance that support efficient, compliant execution.
• Serve as the primary legal partner to the Clinical Trials Capabilities team, providing day-to-day counseling on clinical trial operational capabilities, processes, and issue management, including counsel on core clinical trial documents (e.g., ICFs, clinical trial site agreements); translating legal and regulatory requirements into clear, practical guidance and scalable approaches.
• Support AI and automation initiatives across clinical development and clinical trial operations by advising on legal and regulatory considerations (including appropriate governance) and helping develop scalable, fit-for-purpose approaches that enable innovation while handling risk.
• Provide legal, regulatory, and GCP compliance counsel on R&D Quality matters, including clinical trial risk management, inspection readiness, and response strategy for GCP inspections and related findings.
• Maintain strong awareness of evolving clinical trial related global drug development expectations and emerging laws, regulations, and guidance; translate developments into clear implications, recommendations, and productive guidance for collaborators.
• Influence internal and external collaborators on priority regulatory policy initiatives, in coordination with Global Regulatory Affairs, Policy, and Legal colleagues, to support Lilly’s strategic objectives and protect patient and product integrity.

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 (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree