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.Job DescriptionAt 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. Were looking for people who are determined to make life better for people around the world.Senior Director, Digital Product CounselPurpose:The Senior Director, Digital Product Counsel will serve as the primary legal strategic partner for assigned Lilly digital products and/or platforms, providing comprehensive legal guidance throughout the entire product lifecycle from ideation to launch and beyond. This role requires a sophisticated attorney with exceptional judgment who can navigate the sophisticated intersection of pharmaceutical regulations, digital innovation, data privacy, intellectual property, and emerging technologies. The successful candidate will be a trusted advisor to product teams, engineering, and business leaders, helping Lilly advance its digital transformation while leading legal risks and ensuring compliance with global regulations.This position offers the opportunity to shape the legal framework for pioneering digital health solutions, AI-powered platforms, patient engagement technologies, and enterprise digital tools that are trredefiningow we discover, develop, and deliver medicines to patients worldwide. The role reports to the Vice President, Assistant General Counsel, Chief Privacy Officer and Head of the Digital Legal Office.Key Responsibilities:Strategic Product Counseling<ul><li>Serve as the primary legal contact and strategic advisor for cross-functional digital product and/or platform teams throughout the product development lifecycle, from concept through launch and beyond</li><li>Partner with product managers, engineers, designers, and data scientists to identify and address legal issues early in the development process</li><li>Provide solution-oriented legal guidance on complex matters involving technology products</li><li>Develop and implement legal strategies that enable innovation while handling regulatory, privacy, intellectual property, and commercial risks through collaboration across the Legal department</li><li>Participate in product strategy sessions and sprint planning to ensure legal considerations are integrated into product roadmaps</li></ul>Regulatory and Compliance Leadership<ul><li>Navigate sophisticated regulatory frameworks affecting digital health products, including FDA regulations for software as medical device (SaMD), clinical decision support tools, and digital therapeutics</li><li>Counsel on global digital health regulations and coordinate with international legal teams to ensure products meet requirements across multiple jurisdictions</li><li>Partner with regulatory affairs to develop strategies for novel digital products that may not fit traditional regulatory pathways</li><li>Supervise evolving regulations and industry standards related to digital health, AI/ML in healthcare, and pharmaceutical technology</li><li>Support regulatory submissions and interactions with health authorities regarding digital products where applicable</li></ul>Data Privacy and Security<ul><li>Partner with privacy and cybersecurity legal teams to provide expert counsel on data privacy laws affecting digital products, including GDPR, CCPA/CPRA, and emerging state and international privacy regulations</li><li>Collaborate with privacy and cybersecurity teams to implement privacy-by-design principles in all digital solutions</li><li>Counsel on data governance strategies for AI/ML models, real-world evidence platforms, and patient data analytics</li><li>Guide teams on ethical use of data, algorithmic clarity, and bias mitigation in AI-powered products</li><li>Support incident response and breach notification processes for digital products and platforms</li></ul>Intellectual Property and Technology Transactions<ul><li>Partner with IP legal team to develop strategies for protecting digital innovations, including software patents, trade secrets, and copyrights</li><li>Review and negotiate complex technology agreements, including SaaS agreements, API licenses, cloud services agreements, and strategic partnership deals</li></ul>Commercial and Strategic Partnerships<ul><li>Advise on business models for digital products, including subscription services, value-based contracts, and data monetization strategies</li><li>Support commercial teams on marketing and promotion of digital health solutions</li><li>Guide teams on competitive intelligence and antitrust considerations in digital markets</li></ul>Risk Management and Governance<ul><li>Identify and assess legal risks across the digital product portfolio and develop mitigation strategies</li><li>Create and maintain legal playbooks and guidelines for common digital product scenarios</li><li>Support the development of governance frameworks for AI/ML systems, including model validation and monitoring</li><li>Collaborate with ethics and compliance teams on digital product policies and procedures</li></ul>Leadership and Stakeholder Management<ul><li>Build trusted relationships with senior business leaders and serve as a strategic thought partner</li><li>Lead and mentor other legal professionals supporting digital initiatives</li><li>Collaborate with other legal specialty teams to address multi-disciplinary legal issues</li><li>Partner with government affairs on policy matters affecting digital health and pharmaceutical technology</li><li>Represent Lilly in industry forums and contribute to the development of industry standards as directed</li></ul>Basic Qualifications:<ul><li>J.D. degree</li><li>Active license to practice law in at least in one U.S. state and in good standing</li><li>Minimum of 6 years of legal experience, focused on technology, digital products, or life sciences</li><li>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/or visas for this role.</li></ul>Additional Skills/Preferences:<ul><li>Substantial experience providing legal counsel on product development in technology or healthcare companies</li><li>Experience with data privacy laws and regulations, including GDPR, CCPA, and healthcare privacy frameworks</li><li>Experience with FDA regulations related to digital health, software as medical device, or pharmaceutical products</li><li>Consistent record of handling sophisticated, multi-stakeholder legal matters</li></ul><ul><li>Experience as product counsel or in similar role at a technology company (preferably in health tech)</li><li>In-house legal experience at a Fortune 500 company or equivalent</li><li>Knowledge of AI/ML regulations and ethical frameworks in healthcare</li><li>Experience with cloud computing, API ecosystems, and modern software development practices</li><li>Familiarity with agile development methodologies and product management frameworks</li><li>Knowledge of international digital health regulations and cross-border data transfer requirements</li><li>Track record of successfully launching innovative digital products in regulated industries</li><li>Strong technical proficiency with ability to quickly understand sophisticated technologies and translate technical concepts into legal risk assessments</li><li>Exceptional business insight and ability to balance legal risks with business objectives</li><li>Outstanding written and verbal communication skills with ability to influence senior partners</li><li>Validated ability to work independently and lead multiple sophisticated projects simultaneously</li><li>Growth mindset with passion for continuous learning in constantly evolving field</li><li>Collaborative approach with ability to build consensus across diverse team member groups</li><li>Critical thinking skills with ability to anticipate future legal challenges and opportunities</li><li>Demonstrated commitment to innovation and digital transformation</li><li>Experience leading or participating in digital transformation initiatives</li></ul>Preferred Location:Indianapolis, IN (headquarters). Open to other major Lilly locations or remote arrangement for exceptional candidates, with quarterly travel to Indianapolis and other sites as needed to support business objectives.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 (<a target="_blank" href="https://careers.lilly.com/us/en/workplace-accommodation">https://careers.lilly.com/us/en/workplace-accommodation</a>) 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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.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<h3></h3>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

Eli Lilly

Senior Director - Counsel - Digital Product Counsel

Eli Lilly