Senior Director- Counsel, Infectious Disease & Vaccines, Regulatory Legal

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Senior Director- Counsel, Infectious Disease & Vaccines, Regulatory Legal

This position will be part of the Regulatory Legal Team (RLT), 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 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), Product Development Legal, International Business Unit Legal (IBU Legal), IP, Litigation, and other legal and risk functions to deliver cohesive, forward‑looking guidance that enables innovation while managing legal and regulatory risk. The Senior Director- Counsel, Infectious Disease & Vaccines, Regulatory Legal will serve as Lilly's dedicated regulatory legal lead for its newly formed infectious disease and vaccines portfolio. This role requires a leader who thrives amid ambiguity; can build legal frameworks where none exist; and who brings the subject matter expertise, strategic vision, and proactive orientation to the role. The candidate will be a builder – not merely a counselor – and will be instrumental in establishing the legal function’s role and credibility within this new business area. This is a rare opportunity to shape an emerging franchise from the ground up.

Responsibilities

• Strategic Regulatory Legal Leadership
• Vaccine regulatory strategy: Serve as the primary regulatory legal partner to the Vaccines & Infectious Disease team, providing day‑to‑day and strategic legal counsel on vaccine‑specific regulatory pathways globally.
• Health authority engagement: Lead regulatory legal strategy for agency interactions with global health authorities, including high‑profile regulatory issues, inspections, enforcement matters, dispute resolution, and other significant agency engagements.
• Advisory committee and immunization policy: Advise on advisory committee strategy and immunization policy dynamics (e.g., ACIP), in partnership with Policy and Government Affairs.
• Emerging regulatory issues: Maintain strong situational awareness of evolving laws, regulations, and guidance applicable to vaccines and biologics to anticipate and assess risks and opportunities.
• Enterprise leadership: Partner with senior leaders across Clinical Development, Regulatory Affairs, Manufacturing & Quality, Patient Safety, Commercial, Policy and Legal to shape regulatory strategies for the vaccines and infectious disease portfolio.
• Portfolio integration: Lead regulatory legal workstreams for the integration of newly acquired assets and platforms; providing tailored, program‑specific counsel across all stages of product and platform lifecycle.
• Legal capability building: Build and scale the regulatory legal capability for the portfolio, including governance models and external counsel strategy. Partner across Legal to align support and prepare for portfolio growth.
• Lifecycle execution: Serve as the lead for the implementation and execution of regulatory legal support across the portfolio lifecycle including clinical development, pharmacovigilance, and manufacturing/quality in collaboration with RLT and other legal subject‑matter experts.
• Cross‑functional partnership: Deliver integrated legal guidance to key functions (Clinical Development, Regulatory Affairs, Patient Safety, Manufacturing & Quality, Commercial, and Policy) while operating as a proactive solutions‑oriented partner in a complex, matrixed environment.

Basic Requirements

• Bachelor's Degree
• JD Degree (or equivalent)
• Licensed to practice law in one of the 50 US states.
• 5 years plus of overall legal experience, including substantial experience advising on biologics regulatory matters, gained within a regulatory agency, law firm, and/or as in‑house counsel at a pharmaceutical or biotechnology company.
• Prior in‑house experience supporting vaccine development or commercialization, or equivalent law firm experience with vaccine manufacturer clients.
• 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.

Additional Skills/Preferences

• Demonstrated ability to lead sophisticated, high‑stakes regulatory legal matters with limited precedent and significant ambiguity.
• Highly motivated self‑starter with the drive to build a legal function in a new business area.
• Excellent judgment, strong interpersonal skills, and the ability to work effectively with team members, other lawyers, and senior management across all levels of the Company.
• Familiarity with vaccine‑specific legal frameworks including VICP, PREP Act/CICP, VFC Program, BARDA contracting, and ACIP recommendation mechanics and legal consequences.
• Experience advising on vaccine clinical trials and clinical trial safety, including trial design, informed consent, data safety monitoring, and adverse event reporting.
• Experience advising on biologics manufacturing compliance.
• Prior regulatory agency experience.
• Experience advising on global vaccine regulatory submissions across multiple jurisdictions (e.g., EU, Japan, Switzerland, Brazil, Canada).

Other Information

Indianapolis or Washington, DC preferred. Remote/hybrid work may be acceptable. Travel of approximately 10‑15% is expected, including travel to Lilly's Indianapolis headquarters.

EEO Statement

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.