Sr. Director - eCOA Program Lead

About the role

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.

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

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
• 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
• 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

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

Skills

• Strategic thinking and decision-making
• Excellent communication and interpersonal skills
• Ability to manage multiple projects and priorities simultaneously
• Strong analytical and problem-solving skills
• Experience with project management tools and methodologies
• Knowledge of regulatory requirements and industry standards
• Experience with data analytics and machine learning
• Ability to lead and mentor others

Benefits

• Comprehensive health and wellness programs
• Flexible work arrangements
• Professional development opportunities
• Employee discounts and perks
• Community involvement and volunteer opportunities

Pay

• $156,000 - $228,800

Schedule

• Full-time