Sr. Director - eCOA Program Lead

Eli Lilly and Company • Us, IN

9h

About The Position

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.

Requirements

• 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

Nice To Haves

• 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 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 — 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

Responsibilities

• 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 drive improvement
• Own resolution and the leadership communications for eCOA issues in the TA
• Track issue patterns and root causes to identify systemic issues and improvement opportunities
• Facilitate cross-functional problem-solving for complex eCOA challenges, navigating organizational complexity with clarity
• Ensure no critical issues reach TA leadership without prior communication and a recommended path forward
• Stay current on Atom5 platform capabilities and limitations, bringing TA context to platform selection and fit-for-purpose assessments
• Contribute to the Atom5 roadmap by synthesizing delivery insights and indication package requirements into prioritized recommendations
• Lead fit-for-purpose evaluations of emerging eCOA technologies and recommend adoption strategies aligned with TA objectives
• Partner with DnA, Clinical Capabilities, and Quality teams to maintain inspection readiness across eCOA delivery in the TA
• Ensure eCOA practices align with GCP, 21 CFR Part 11, and Lilly quality requirements — identifying and closing compliance gaps early
• Mentor junior eCOA 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 eCOA delivery quality, platform performance, and process efficiency
• Contribute to shared learning forums and knowledge exchange across the eCOA community of practice

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• 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: Director