Senior Director – Counsel, Clinical Development, Regulatory Legal

Eli Lilly and Company

Senior Director - Counsel providing regulatory legal counsel for clinical development at Lilly. Focused on innovative solutions and compliance with applicable laws and standards.

Posted 5/5/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $195,000 - $314,600 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Provide strategic, solutions-oriented legal counsel and regulatory and Good Clinical Practice (GCP) expertise in support of Lilly’s clinical development programs
Serve as the primary legal partner to the Clinical Trials Capabilities team
Support AI and automation initiatives across clinical development and clinical trial operations
Provide legal, regulatory, and GCP compliance counsel on R&D Quality matters
Maintain strong awareness of evolving clinical trial related global drug development expectations and emerging laws, regulations, and guidance
Influence internal and external collaborators on priority regulatory policy initiatives

Requirements

What you’ll need

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)
Highly motivated and collaborative partner with strong communication skills
Excellent judgment and meticulous level of attention to detail
Excellent written and verbal communication skills with an ability to influence others
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

Benefits

Comp & perks

Comprehensive benefit program
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
Time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

legal counselregulatory complianceGood Clinical Practice (GCP)clinical developmentclinical trial operationsR&D Qualityregulatory policyconfidential information handlinglegal researchcontract negotiation

Soft Skills

collaborationcommunicationjudgmentattention to detailinfluenceadaptabilityleadershipefficiencymotivationdedication

Certifications

Doctor of Jurisprudence (J.D.)licensed to practice law