Associate Vice President, Agentic AI & Autonomous CMC Development
PharmaBiotechMedTechRegulatory AffairsQuality Assuranceregulatory submissionemacroraveinform
Job description
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. Organization Overview: At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. Lilly has led global healthcare for more than 140 years, and today we're growing faster than ever, expanding our portfolio, modalities and manufacturing footprint. To keep delivering medicines faster, with greater quality and efficiency, we're investing in the next generation of digital and AI capability that will change how we research, develop and make decisions. Position Overview: We're looking for a visionary executive to lead the next paradigm shift in pharmaceutical development: agentic AI. This is the shift from human-executed workflows supported by software to autonomous, AI-enabled development ecosystems, where scientists and engineers spend their time on creativity, judgment and strategy while intelligent agents handle routine knowledge work, analysis, documentation, planning and execution. This Associate Vice President will define and execute Lilly's vision for Agentic CMC Development: building a pan-DDCS/PRD AI capability platform and deploying agentic solutions that transform how development work gets done across drug delivery, devices, combination products, synthetic molecule development, biologics, formulation sciences, process development, analytical sciences, quality, regulatory and the manufacturing interface. The long-term goal is an Autonomous Development Platform: one that continuously learns from enterprise knowledge, experimental outcomes, development history, manufacturing performance, regulatory interactions and scientific literature, and increasingly executes development work on its own. This platform will enable: Agent-driven knowledge discovery and technical intelligence Autonomous technical workflow orchestration AI-generated development strategies and experiment plans Automated documentation and regulatory content generation AI-assisted design, optimization, change control planning and risk assessment Digital experts and copilots embedded across development functions Enterprise-scale scientific knowledge management Agentic coordination between development, manufacturing, quality and regulatory functions Key Responsibilities: This is a leadership role that builds and grows a dedicated agentic AI team, establishes the DDCS/PRD wide capability platform, and integrates it seamlessly into all processes of CMC development. As the functional technical leader, you partner with scientists, engineers and senior leaders across DDCS/PRD, Manufacturing, Discovery, Business Units, and corporate AI leadership to turn this vision into production reality. You'll serve as a CMC champion for agentic AI in development sciences, setting direction, building durable platform assets, and proving measurable gains in speed, quality and productivity across the CMC development lifecycle. 1. Set the Agentic AI Strategy and Roadmap Serve as the single point of accountability for DDCS and pan PRD agentic AI strategy, setting a multi-year vision, roadmap and technology strategy for autonomous development systems. Define the future-state operating model for an AI-enabled development organization and prioritize the highest-value opportunities for transformation. Build the business case and champion narrative that win support from scientists, engineers and senior leaders, addressing both the opportunity and the risks of agentic AI openly and directly. Track Lilly's growing portfolio of agentic AI initiatives and external pharma agentic AI moves, translating industry and competitive trends into roadmap decisions. 2. Own the Agentic AI Platform Architecture Lead development of an enterprise-scale platform spanning multi-agent orchestration frameworks, large language model ecosystems, agent memory architectures, retrieval-augmented generation and knowledge graph systems, digital twin and simulation integration, and autonomous workflow engines. Establish standards for agent-to-agent and tool communication (for example, Model Context Protocol and Agent-to-Agent standards) so agents work together across the pan PRD data and knowledge landscape. Build reusable enterprise capabilities that DDCS, BRD, SMDD and Manufacturing can all adopt. Build in responsible AI controls from the start: human-in-the-loop quality systems, AI governance and compliance frameworks, and GxP/21 CFR Part 11 auditability for every agent output that touches a regulatory submission. 3. Build and Lead the Agentic AI Development Team Recruit, build and lead a world-class team of AI scientists, AI application engineers, software architects, product managers, workflow transformation leaders and domain experts. Recruit and develop top talent from the pharmaceutical, technology, AI and startup ecosystems, building an organization recognized as an industry leader in applying agentic AI to scientific and engineering development. Foster a culture of experimentation, innovation, speed and continuous learning. Talent Magnet and Builder: Attract, develop and retain exceptional technical and business talent while building future leadership pipelines. 4. Lead Agentic Solution Development End-to-End Lead deployment of intelligent agent ecosystems across CMC development workflows, including scientific knowledge discovery and synthesis, literature mining and competitive intelligence, experiment planning and optimization, formulation design support, process development optimization, design, technical report authoring, regulatory submission content generation, and quality investigations. Develop full-stack applications that integrate large language models, retrieval-augmented generation and agentic workflows with intuitive front ends and secure back-end services, automating today's manual CMC development data and documentation tasks. Drive the transition from manual, document-centric workflows to autonomous, AI-native development processes, monitoring and evaluation practices that keep agents accurate, fast and cost-effective after launch. 5. Orchestrate Cross-Functional Delivery with CMC development partners Serve as the bridge between DDCS/PRD scientists, engineers, quality, manufacturing and regulatory colleagues and the technical team, translating business needs into technical requirements and technical capability into business value. Partner with corporate AI, digital and business leadership to align DDCS and PRD initiatives with Lilly's broader AI strategy, driving adoption of agentic operati
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