Sr. Director - eCOA Program Lead

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.About the roleAs the eCOA Program Lead for your assigned therapeutic area, you will serve as the senior point of contact between eCOA capability teams, TA stakeholders, and the broader clinical development organization. You will shape how eCOA is delivered, governed, and continuously improved.You work effectively across all levels of the organization: advising Clinical Development Leaders and DnA 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 eCOA capability for the therapeutic area.What you'll doeCOA strategy and TA leadershipServe as the primary eCOA authority for the therapeutic area — providing guidance to DnA Senior Directors, Clinical Development Leaders, and CDDA partnersDevelop deep familiarity with the TA's clinical pipeline, indication package status, and Disease State Measurement Strategy — anticipating eCOA needs before they become issuesBuild and implement eCOA delivery strategies for the TA, contributing to platform selection and integrated functional sourcingEngage in TA governance and portfolio planning forums, providing the eCOA perspective on investment priorities and study design decisionsProvide structured feedback from trial execution back to DSMS and platform teams to drive improvementEscalation management and issue resolutionOwn resolution and the leadership communications for eCOA issues in the TATrack issue patterns and root causes to identify systemic issues and improvement opportunitiesFacilitate cross-functional problem-solving for complex eCOA challenges, navigating organizational complexity with clarityEnsure no critical issues reach TA leadership without prior communication and a recommended path forwardPlatform strategyStay current on Atom5 platform capabilities and limitations, bringing TA context to platform selection and fit-for-purpose assessmentsContribute to the Atom5 roadmap by synthesizing delivery insights and indication package requirements into prioritized recommendationsLead fit-for-purpose evaluations of emerging eCOA technologies and recommend adoption strategies aligned with TA objectivesInspection readiness and qualityPartner with DnA, Clinical Capabilities, and Quality teams to maintain inspection readiness across eCOA delivery in the TAEnsure eCOA practices align with GCP, 21 CFR Part 11, and Lilly quality requirements — identifying and closing compliance gaps earlyCapability development and improvementMentor junior eCOA colleagues on stakeholder management, platform expertise, escalation handling, and professional growthLead root cause analysis and corrective action initiatives, identifying patterns and driving lasting improvementsEstablish and track TA-level indicators for eCOA delivery quality, platform performance, and process efficiencyContribute to shared learning forums and knowledge exchange across the eCOA community of practiceMinimum qualificationsBachelor'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 industryOrMasters 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 industryPreferred qualificationsExperience in a senior advisory, SME, or portfolio leadership role within a therapeutic areaFamiliarity with Disease State Measurement Strategy (DSMS) development and its application to eCOA and study designBackground in inspection support, audit readiness, or regulatory submissions related to eCOA or clinical dataExperience with modern data technologies in clinical development (AI/ML, RPA, cloud-based systems)Familiarity with external eCOA standards bodies (e.g., C-Path, TransCelerate, FDA PRO guidance)Deep understanding of Lilly's clinical development processes, CDDA operating model, and Atom5 platformProven ability to work independently in a complex, matrixed environment — setting direction and influencing without direct authorityStrong track record of cross-functional partnership across Clinical Development, Data Management, Tech@Lilly, and QualityDeep understanding of CDM processes and regulatory requirements, including GCP, 21 CFR Part 11, and CDISC standardsExperience driving process improvement initiatives with measurable outcomesLilly 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 (https://careers.lilly.com/us/en/workplace-accommodation) 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