Description:

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.

Senior Director – Counsel, Integrated Patient Safety, Regulatory Legal

Organization Overview:
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. 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, 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.

Responsibilities:
The primary responsibility of this position is to provide strategic, solutions-oriented legal counsel and pharmacovigilance subject matter expertise in support of Lilly's broad portfolio of products – both in development and marketed. This role will provide strategic counsel to the various pillars of the Global Patient Safety organization, enabling modern pharmacovigilance practices, use of AI to streamline processes, and appropriate governance processes. This role will also partner with colleagues supporting clinical development on matters where patient safety and development activities intersect. This role requires strong judgment and innovative thinking on sophisticated, novel issues while ensuring that Lilly's pharmacovigilance and clinical development practices are conducted in accordance with applicable laws, regulations, and internal standards.

Key Responsibilities include:

Pharmacovigilance operations: 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. This requires the ability to translate legal concepts into clear, actionable guidance for business partners operating in a fast-paced, high-volume environment while navigating sophisticated regulatory requirements.
Safety governance: Provide legal advice and support to product level safety management teams, including assessment of emerging safety issues, proposed labeling language, and updates.
Clinical Development Interface: Partner with Regulatory Legal Team and other colleagues on clinical development matters where patient safety considerations intersect, giving pharmacovigilance perspective as needed.
AI/automation enablement: 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.
PV quality and inspection readiness: 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.
Emerging regulatory issues & guidance: 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.
Policy and stakeholder influence: 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.

Basic 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 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:

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

Other Information: