Serve as the senior point of contact between e. COA capability teams, TA stakeholders, and the broader clinical development organization. You will shape how e. COA is delivered, governed, and continuously improved. You work effectively across all levels of the organization: advising Clinical Development Leaders and Dn. A Senior Directors with executive-ready guidance while staying close enough to delivery to resolve complex issues and drive operational excellence. You anticipate needs before they are articulated, own outcomes end-to-end, and drive lasting improvements in e. COA capability for the therapeutic area. What you'll doe. COA strategy and TA leadership. Serve as the primary e. COA authority for the therapeutic area — providing guidance to Dn. A Senior Directors, Clinical Development Leaders, and CDDA partners. Develop deep familiarity with the TA's clinical pipeline, indication package status, and Disease State Measurement Strategy — anticipating e. COA needs before they become issues. Build and implement e. COA delivery strategies for the TA, contributing to platform selection and integrated functional sourcing. Engage in TA governance and portfolio planning forums, providing the e. COA perspective on investment priorities and study design decisions. Provide structured feedback from trial execution back to DSMS and platform teams to drive improvement. Escalation management and issue resolution. Own resolution and the leadership communications for e. COA issues in the TA - Track issue patterns and root causes to identify systemic issues and improvement opportunities. Facilitate cross-functional problem-solving for complex e. COA challenges, navigating organizational complexity with clarity. Ensure no critical issues reach TA leadership without prior communication and a recommended path forward. Platform strategy. Stay current on Atom 5 platform capabilities and limitations, bringing TA context to platform selection and fit-for-purpose assessments. Contribute to the Atom 5 roadmap by synthesizing delivery insights and indication package requirements into prioritized recommendations. Lead fit-for-purpose evaluations of emerging e. COA technologies and recommend adoption strategies aligned with TA objectives. Inspection readiness and quality. Partner with Dn. A, Clinical Capabilities, and Quality teams to maintain inspection readiness across e. COA delivery in the TA - Ensure e. COA practices align with GCP, 21 CFR Part 11, and Lilly quality requirements — identifying and closing compliance gaps early. Capability development and improvement. Mentor junior e. COA colleagues on stakeholder management, platform expertise, escalation handling, and professional growth. Lead root cause analysis and corrective action initiatives, identifying patterns and driving lasting improvements. Establish and track TA-level indicators for e. COA delivery quality, platform performance, and process efficiency. Contribute to shared learning forums and knowledge exchange across the e. COA community of practice. Minimum qualifications. Bachelor's degree in life sciences, data science, computer science, or a related STEM field with 10 years of experience in clinical data management, clinical drug development, or a related field within pharmaceutical, biotech, or CRO industry. Or. Masters in life sciences, data science, computer science, or a related STEM field with 7 years of experience in clinical data management, clinical drug development, or a related field within pharmaceutical, biotech, or CRO industry. Preferred qualifications. Experience in a senior advisory, SME, or portfolio leadership role within a therapeutic area. Familiarity with Disease State Measurement Strategy (DSMS) development and its application to e. COA and study design. Background in inspection support, audit readiness, or regulatory submissions related to e. COA or clinical data. Experience with modern data technologies in clinical development (AI/ ML, RPA, cloud-based systems)Familiarity with external e. COA standards bodies (e.g., C-Path, Trans. Celerate, FDA PRO guidance)Deep understanding of Lilly's clinical development processes, CDDA operating model, and Atom 5 platform. Proven ability to work independently in a complex, matrixed environment — setting direction and influencing without direct authority. Strong track record of cross-functional partnership across Clinical Development, Data Management, Tech@Lilly, and Quality. Deep understanding of CDM processes and regulatory requirements, including GCP, 21 CFR Part 11, and CDISC standards. Experience driving process improvement initiatives with measurable outcomes. 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