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

Key responsibilities include: 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 & Lifecycle Execution - 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 (U.S) or equivalent qualifying law degree from outside of US (ex: LL.B.) that enables entry into legal practice in the local jurisdiction - 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, 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 - 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance.

Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. 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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $195,000 - $286,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly