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

Lilly • Washington, DC

12d • $195,000 - $286,000 • Hybrid

About The Position

This position 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 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.

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 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

• 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)

Responsibilities

• 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.
• 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.
• Advise on advisory committee strategy and immunization policy dynamics (e.g., ACIP), in partnership with Policy and Government Affairs.
• Maintain strong situational awareness of evolving laws, regulations, and guidance applicable to vaccines and biologics to anticipate and assess risks and opportunities.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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