Senior Director - Counsel, Clinical Development, Regulatory Legal

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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.

Responsibilities:

The primary responsibility of this position is to 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.

In this capacity, the role will help enable modernization of clinical trials through AI, automation, and scalable processes and governance that support efficient, compliant execution. This role requires strong judgment and innovative thinking on sophisticated, novel issues while ensuring Lilly’s research and development is conducted in accordance with applicable laws, regulations, and internal standards.

Key responsibilities include:

• Clinical Trials Capabilities partnership: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.
• AI/automation enablement: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.
• R&D quality and inspection readiness: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.
• Emerging regulatory issues & guidance: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.
• Policy and collaborator influence: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.

Basic 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 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/Preferences

• 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.

Other Information

• No more than 10-15% travel is expected.
• The role may involve some travel to Lilly’s clinical trial sites and, for remote roles located outside of Indianapolis, IN, occasional travel to Lilly’s corporate headquarters located in Indianapolis.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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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