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 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 drive improvement

Escalation management and issue resolution

• 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

Platform strategy

• 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

Inspection readiness and quality

• 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

Capability development and improvement

• 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

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 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

Lilly 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 (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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