Lilly
Healthcare
Sr.Director-eCOAProgramLead
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“Sr. Director - eCOA Program Lead at Lilly. Skills: eCOA Program Lead, Clinical data management, Regulatory requirements. Serve as primary eCOA authority for therapeutic area. Provide guidance to DnA Senior Directors, Clinical Development”
What You'll Achieve.
Drive lasting improvements in eCOA capability
Industry & Context.
Issue resolution; Root cause analysis; Corrective action initiatives
What They're Looking For.
Must Have
Bachelor's degree in life sciences, data science, computer science, or related STEM field with 10+ years of experience in clinical data management, clinical drug development, or related field within pharmaceutical, biotech, or CRO industry, Master's degree in life sciences, data science, computer science, or related STEM field with 7+ years of experience in clinical data management, clinical drug development, or related field within pharmaceutical, biotech, or CRO industry
Nice to Have
Experience in senior advisory, SME, or portfolio leadership role within a therapeutic area, Familiarity with Disease State Measurement Strategy (DSMS) development and its application to eCOA and study design, Background in inspection support, audit readiness, or regulatory submissions related to eCOA or clinical data, Experience 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 platform, Proven ability to work independently in a complex, matrixed environment, 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
What You'll Do.
Serve as primary eCOA authority for therapeutic area
Provide guidance to DnA Senior Directors
Develop deep familiarity with TA's clinical pipeline
Anticipate eCOA needs before they become issues
Build and implement eCOA delivery strategies for the
Contribute to platform selection and integrated functional sourcing
Engage in TA governance and portfolio planning forums
Provide eCOA perspective on investment priorities and study
Provide structured feedback from trial execution back to
Drive improvement in DSMS and platform teams
Own resolution and leadership communications for eCOA issues
Track issue patterns and root causes
Identify systemic issues and improvement opportunities
Facilitate cross-functional problem-solving for complex eCOA challenges
Navigate organizational complexity with clarity
Ensure no critical issues reach TA leadership without
Stay current on Atom5 platform capabilities and limitations
Bring TA context to platform selection and fit-for-purpose
Contribute to Atom5 roadmap by synthesizing delivery insights
Provide prioritized recommendations for Atom5 roadmap
Lead fit-for-purpose evaluations of emerging eCOA technologies
Recommend adoption strategies aligned with TA objectives
Clinical Capabilities
Maintain inspection readiness across eCOA delivery in the
Ensure eCOA practices align with GCP
Identify and closing compliance gaps early
Mentor junior eCOA colleagues on stakeholder management
Mentor junior eCOA colleagues on platform expertise
Mentor junior eCOA colleagues on escalation handling
Mentor junior eCOA colleagues on professional growth
Lead root cause analysis and corrective action initiatives
Identify patterns and driving lasting improvements
Establish and track TA-level indicators for eCOA delivery
Establish and track TA-level indicators for platform performance
Establish and track TA-level indicators for process efficiency
Contribute to shared learning forums and knowledge exchange
How You'll Work.
Team & Collaboration
Cross-functional problem-solving; Stakeholder management; Cross-functional partnership
Communication Scope
Executive guidance; Leadership communications
Process & Methodology
Portfolio planning, Roadmap planning
Full Job Description
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 role As 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 do **eCOA strategy and TA leadership** * Serve as the primary eCOA authority for the therapeutic area — providing guidance to DnA 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 eCOA needs before they become issues * Build and implement eCOA delivery strategies for the TA, contributing to platform selection and integrated functional sourcing * Engage in TA governance and portfolio planning forums, providing the eCOA perspective on investment priorities and study design decisions * Provide structured feedback from trial execution back to DSMS and platform teams to d
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