Eli Lilly

Sr. Director - eCOA Program Lead

Eli Lilly$156K — $228K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's in life sciences, data science, computer science, or a related STEM field with 10+ years experience in clinical data management or drug development, or
  • Master's in life sciences, data science, computer science, or a related STEM field with 7+ years experience in the same areas.
  • Proven experience in advisory or leadership roles within a therapeutic area.
  • Deep understanding of Disease State Measurement Strategy (DSMS) relevant to eCOA.
  • Knowledge of regulatory standards including GCP, 21 CFR Part 11.

Responsibilities

  • Serve as primary eCOA authority for the therapeutic area, providing guidance to clinical leaders.
  • Develop and implement eCOA delivery strategies based on TA needs and preferences.
  • Engage in governance forums to contribute eCOA insights on priorities and study design.
  • Own resolution and leadership communication for eCOA issues within the TA.
  • Track issue patterns to identify systemic challenges and drive improvement opportunities.
  • Lead evaluations of eCOA technologies and recommend fit-for-purpose solutions.
  • Ensure compliance with quality requirements and maintain readiness for inspections.

Benefits

  • Comprehensive benefits program including medical, dental, and prescription drug coverage.
  • 401(k) and pension plan participation.
  • Vacation and leave of absence benefits.
  • Well-being initiatives including employee assistance programs and fitness benefits.
  • Eligibility for company performance bonuses.
Full Job Description
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[redacted], 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

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$156,000 - $228,800

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.

#WeAreLilly

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ

Similar Jobs

More Jobs at Eli Lilly

More Pharmaceuticals & Biotech Jobs

Find similar Sr. Director - eCOA Program Lead jobs: