Senior Director – Counsel, Integrated Patient Safety, Regulatory Legal

Eli Lilly and Company • Indianapolis, IN

2d • Hybrid

About The Position

The Senior Director - Counsel, Integrated Patient Safety will be part of the Regulatory Legal Team (RLT), which is a core strategic 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 core legal expertise for the Company on global regulatory laws, including pharmacovigilance, clinical development and registration, manufacturing and quality, 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 and JD Degrees
• Licensed to practice law in one of the US states
• Minimum 5-10 years of overall experience in a law firm or as an in-house lawyer in a device or pharmaceutical company
• 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

• Prior regulatory agency experience
• Ability to triage, prioritize and effectively counsel a high volume of inputs from a variety of sources
• Highly motivated and collaborative partner with strong interpersonal skills and the ability to work effectively with team members, other 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
• Proven ability to appropriately handle highly confidential information
• Proven dedication to expand knowledge and adapt to a changing, rapid-paced environment
• Proven leadership and effectiveness in working with senior leadership
• Prior experience advising on pharmacovigilance, drug safety, clinical development, or related regulatory matters
• Familiarity with global PV frameworks
• Experience advising on AI/automation governance or digital health initiatives

Responsibilities

• Serve as the primary legal partner to the pharmacovigilance operations team, providing day-to-day counseling on case management, safety surveillance, safety contracting, vendor oversight, and post-market safety surveillance studies.
• Provide legal advice and support to product level safety management teams, including assessment of emerging safety issues, proposed labeling language, and updates.
• Partner with Regulatory Legal Team and other colleagues on clinical development matters where patient safety considerations intersect, giving pharmacovigilance perspective as needed.
• Support AI and automation initiatives across Global Patient Safety and Clinical Development 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 GxP compliance counsel on PV Quality matters, including PV risk management, legal support for internal audits, inspection readiness, and response strategy for PV inspections, safety topics related to GCP inspections, and related findings.
• Maintain strong awareness of evolving pharmacovigilance and clinical development related laws, regulations, and guidance; translate developments into clear implications, recommendations, and productive guidance for collaborators.
• Influence internal and external customers 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
• 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
• 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: Senior