Associate Vice President - Head of Digital Strategy and Innovation - Global Regulatory Affairs

Eli Lilly and Company • Us, IN

28d • $243,000 - $391,600 • Hybrid

About The Position

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. The purpose of the Head of Digital Strategy and Innovation, Global Regulatory Affairs is to lead the digital transformation and automation agenda across Global Regulatory Affairs. This role serves as the strategic digital enabler for Global Regulatory Affairs by driving implementation of AI/ML applications, advanced analytics and digital capabilities that accelerate regulatory delivery and create competitive advantage. The AVP/VP partners with the RIM System and Data Quality Owner to ensure strategic data stewardship across GRA and enable informed decision-making and business intelligence. This role is accountable for establishing performance metrics and real-time dashboards that track organizational effectiveness, identify improvement opportunities, and demonstrate business impact. This role works closely with Global Process Owners to translate strategic digital and operational visions into tactical execution plans, ensuring that innovative ideas are implemented effectively across the organization. The Head of Digital Strategy and Innovation, Global Regulatory Affairs partners closely with IT, external technology vendors, and cross-functional teams to identify, evaluate, and implement innovative solutions. The role serves as a strategic business partner to the GRA Lead Team, ensuring that digital and business operations capabilities position GRA as a leader in regulatory innovation and operational excellence.

Requirements

• Experience in pharmaceutical industry with significant focus on digital transformation, technology implementation, data analytics, and/or operational excellence
• Deep expertise in digital transformation, AI/ML applications, data analytics, and/or operational excellence in pharmaceutical or highly regulated industry
• Demonstrated ability to lead and drive technology-driven and operational improvement initiatives in complex organizations
• Strong understanding of pharmaceutical drug development process and regulatory affairs operations
• Experience with regulatory information management systems (e.g., Veeva RIM), data governance, and analytics platforms
• Leadership experience developing/leading teams
• Proven ability to translate strategic visions into tactical execution plans with measurable results
• Commitment to fostering inclusive, high-performing team culture that values innovation and innovative ideas
• Bachelor's degree in IT, data science, engineering, life-sciences, or related field; advanced degree preferred

Nice To Haves

• Experience in regulatory affairs or quality systems beneficial

Responsibilities

• Develop and implement a comprehensive digital/automation strategy aligned with GRA goals and supporting organizational transformation
• Translate strategic digital and operational visions into tactical execution plans with clear achievements, owners, and success criteria
• Reduce regulatory submission cycle times and increase productivity through automation and standardization.
• Lead identification, evaluation, and development of innovative digital solutions including generative AI, machine learning for data analysis, and automation for routine regulatory tasks
• Drive end-to-end implementation of approved digital and operational initiatives across GRA, ensuring seamless transitions and minimal disruptions
• Champion a culture of innovation and continuous improvement, regularly assessing and enhancing digital and operational capabilities
• Collaborate with RIM System Owner and Master Data Stewards to develop and implement data strategies that enable advanced analytics, business intelligence, and data-driven decision making and position Lilly for future regulatory data initiatives
• Partner with the Business Technology team to develop analytics capabilities that provide strategic insights on portfolio performance, regulatory trends, competitive intelligence, and operational efficiency
• Drive adoption of advanced analytics and visualization tools across GRA and develop real-time dashboards and performance reporting to provide insight into organizational effectiveness
• Collaborate with Global Process Owners to develop comprehensive change-management plans including communication strategies, process optimization, training programs, and adoption metrics for new digital capabilities
• Partner with IT, external technology vendors, and innovation teams to identify emerging technologies applicable to regulatory affairs
• Monitor external environment (academia, vendors, regulators) for novel digital trends, tools, and methods
• Lead, engage, coach, and develop a team of strategic digital leads fostering an inclusive culture shaped by Team Lilly behaviours.
• Manage performance and development of your team, ensuring agile collaboration across the Global Regulatory Affairs teams.
• Recruit, engage, and retain top talent, leading teams within and across functions to superior performance.
• Assure that training curricula for digital, AI and automation tools and data analytics are in place and maintained
• Communicate digital and operational strategies to directors, scientists, and team members across GRA
• Communicate progress on digital and operational initiatives to senior management and Executive Committee members as appropriate
• Translate complex digital and analytical topics for non-technical team members
• Actively participates in industry trade organizations focusing on regulatory informatics, digital transformation, and operational excellence
• Lead business planning activities for digital and operational excellence scope
• Assure on-time and on-budget delivery of digital and operational initiatives
• Develop business cases for digital investments, demonstrating value and business impact
• Allocate resource across digital and operational initiatives based on strategic priorities and business impact
• Manage strategic partnerships with IT, external vendors, and technology providers

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Executive