Associate Director, Clinical Development Trial Lead (CDTL)
Eli Lilly and Company
August 20, 2026
On-site
Indianapolis, IN
Clinical Research and Development
Position Summary
- Independently lead cross-functional study teams for complex clinical trials; accountable regionally and globally to deliver clinical milestones with quality, on time, within scope and budget.
Responsibilities
- Use project management skills/tools to develop and execute local/regional/global clinical trials (scope, timeline/enrollment plan, risk, budget).
- Lead/influence large complex studies and/or multiple smaller studies.
- Drive study team execution/closure with proactive issue management, contingency planning, and resolution.
- Own enrollment strategy/execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to meet enrollment goals.
- Manage TPO (third party organization) qualification, selection, and oversight; serve as point of contact for CRO delivery of milestones.
- Ensure Trial Master File accountability and inspection readiness; document deviations; coach on storyboards/issue summaries.
- Apply GCP/global-regional regulations and Lilly standards; detect/resolve quality issues with appropriate escalation.
- Provide scientific/regulatory technical consultation for clinical/regulatory documents and regulatory Q&A.
Minimum Qualifications
- Bachelor’s degree (scientific/health-related preferred).
- 5+ years clinical research experience (or relevant scientific/health-related experience).
- Authorized to work in the U.S. full-time; no visa sponsorship.
- Onsite at Stamford, CT or Indianapolis, IN (relocation assistance may be provided).
Highly Desired Skills
- Oncology (early phase preferred); radioligand therapy (RLT).
- Project management tools/methodologies; ability to lead cross-culturally; influence without authority; coach others; strong analytical/problem-solving skills.
Benefits (as listed)
- Bonus eligibility; medical/dental/vision/prescription; 401(k) and pension; vacation and flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (EAP, fitness, clubs).
- Independently lead cross-functional study teams for complex clinical trials; accountable regionally and globally to deliver clinical milestones with quality, on time, within scope and budget.
Responsibilities
- Use project management skills/tools to develop and execute local/regional/global clinical trials (scope, timeline/enrollment plan, risk, budget).
- Lead/influence large complex studies and/or multiple smaller studies.
- Drive study team execution/closure with proactive issue management, contingency planning, and resolution.
- Own enrollment strategy/execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to meet enrollment goals.
- Manage TPO (third party organization) qualification, selection, and oversight; serve as point of contact for CRO delivery of milestones.
- Ensure Trial Master File accountability and inspection readiness; document deviations; coach on storyboards/issue summaries.
- Apply GCP/global-regional regulations and Lilly standards; detect/resolve quality issues with appropriate escalation.
- Provide scientific/regulatory technical consultation for clinical/regulatory documents and regulatory Q&A.
Minimum Qualifications
- Bachelor’s degree (scientific/health-related preferred).
- 5+ years clinical research experience (or relevant scientific/health-related experience).
- Authorized to work in the U.S. full-time; no visa sponsorship.
- Onsite at Stamford, CT or Indianapolis, IN (relocation assistance may be provided).
Highly Desired Skills
- Oncology (early phase preferred); radioligand therapy (RLT).
- Project management tools/methodologies; ability to lead cross-culturally; influence without authority; coach others; strong analytical/problem-solving skills.
Benefits (as listed)
- Bonus eligibility; medical/dental/vision/prescription; 401(k) and pension; vacation and flexible benefits; life insurance/death benefits; time off/leave; well-being benefits (EAP, fitness, clubs).