Senior Director – Counsel, Integrated Patient Safety at Lilly

Compensation

$195,000 – $286,000/yr

Setup: Remote, Hybrid
Location: Indianapolis, Indiana
Type: Full-time
Level: Senior

Description

Lilly is seeking a Senior Director - Counsel, Integrated Patient Safety to join their Regulatory Legal Team. This role involves providing strategic legal counsel and pharmacovigilance expertise to ensure compliance with global regulatory laws throughout the product lifecycle, focusing on patient safety, AI/automation, and quality assurance. The successful candidate will collaborate with various departments, manage pharmacovigilance operations, and contribute to shaping regulatory policies.

Required Skills

Legal Counsel
Pharmacovigilance
Regulatory Legal
Clinical Development
AI/Automation
GxP Compliance
Risk Management
Policy Influence

Additional Information

Required Previous Experiences: 5-10 years of overall experience in a law firm or as an in-house lawyer in a device or pharmaceutical company.
Preferred Qualifications: 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.