Associate Director - Clinical Development Trial Lead (CDTL)
Eli Lilly and Company
August 26, 2026
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Purpose
- The Clinical Development Trial Lead (CDTL), Associate Director independently leads cross-functional study teams to develop and execute complex clinical trials; accountable regionally and globally for clinical milestones (quality, on time, within scope and budget).
Primary Responsibilities
- Use project management skills/processes/tools to develop and execute local, regional, and/or global clinical trials (scope, timeline, risk, budget).
- Lead/influence large complex studies and/or multiple smaller studies.
- Drive local/regional/global study team execution through implementation, proactive issue management, contingency planning, and closure.
- Own enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to achieve enrollment goals.
- Serve as single point of contact for trial communication (CDDA, Regional Clinical Operations, TPOs) and manage/influence upward.
- Anticipate and resolve complex technical/operational/business issues with cross-functional teams and vendors; determine escalation needs.
- Manage TPO qualification/selection/oversight; act as CRO point of contact and ensure CRO delivery of milestones.
Clinical Trial Process Leadership & Scientific Expertise
- Influence study design/program decisions; support regional operating model.
- Single point of accountability for Trial Master File (inspection-ready at all times).
- Ensure inspection readiness, timely deviation documentation, and coaching on storyboards/issue summaries.
- Apply global/regional regulations, GCP, and Lilly standards; detect/resolve quality issues and escalate.
- Provide technical consultation for clinical/regulatory documents and responses.
Minimum Qualifications
- Bachelor’s degree (scientific/health-related preferred) OR advanced degree.
- 5+ years clinical research experience (or relevant scientific/health-related experience).
- Work authorization in the U.S.; Lilly does not sponsor visas.
Highly Desired Skills
- Project management methodology/tools; process improvement mindset.
- Cross-cultural leadership; ability to influence without authority; effective communication.
Other Information/Preferences
- 5+ years clinical trial experience; oncology/late-phase; CAR-T; site-level/affiliate experience; local/country requirements.
- Proficiency with tools (e.g., Critical Chain, Veeva, MS Project/Excel/PowerPoint, PowerBI); periodic travel to AST/ISST.
Benefits (if listed)
- Full-time employees may be eligible for company bonus and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
- The Clinical Development Trial Lead (CDTL), Associate Director independently leads cross-functional study teams to develop and execute complex clinical trials; accountable regionally and globally for clinical milestones (quality, on time, within scope and budget).
Primary Responsibilities
- Use project management skills/processes/tools to develop and execute local, regional, and/or global clinical trials (scope, timeline, risk, budget).
- Lead/influence large complex studies and/or multiple smaller studies.
- Drive local/regional/global study team execution through implementation, proactive issue management, contingency planning, and closure.
- Own enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to achieve enrollment goals.
- Serve as single point of contact for trial communication (CDDA, Regional Clinical Operations, TPOs) and manage/influence upward.
- Anticipate and resolve complex technical/operational/business issues with cross-functional teams and vendors; determine escalation needs.
- Manage TPO qualification/selection/oversight; act as CRO point of contact and ensure CRO delivery of milestones.
Clinical Trial Process Leadership & Scientific Expertise
- Influence study design/program decisions; support regional operating model.
- Single point of accountability for Trial Master File (inspection-ready at all times).
- Ensure inspection readiness, timely deviation documentation, and coaching on storyboards/issue summaries.
- Apply global/regional regulations, GCP, and Lilly standards; detect/resolve quality issues and escalate.
- Provide technical consultation for clinical/regulatory documents and responses.
Minimum Qualifications
- Bachelor’s degree (scientific/health-related preferred) OR advanced degree.
- 5+ years clinical research experience (or relevant scientific/health-related experience).
- Work authorization in the U.S.; Lilly does not sponsor visas.
Highly Desired Skills
- Project management methodology/tools; process improvement mindset.
- Cross-cultural leadership; ability to influence without authority; effective communication.
Other Information/Preferences
- 5+ years clinical trial experience; oncology/late-phase; CAR-T; site-level/affiliate experience; local/country requirements.
- Proficiency with tools (e.g., Critical Chain, Veeva, MS Project/Excel/PowerPoint, PowerBI); periodic travel to AST/ISST.
Benefits (if listed)
- Full-time employees may be eligible for company bonus and comprehensive benefits including 401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.