Sr. Director - eCOA Program Lead

Role Overview

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 while advising Clinical Development Leaders and DnA Senior Directors with executive‑ready guidance and staying close enough to delivery to resolve complex issues and drive operational excellence.

• 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 Master's 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, Trans Celerate, 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…