Lilly

Healthcare

Sr.Director-eCOAProgramLead

$156–229k Indianapolis, Indiana, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Director candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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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