Associate Director - Clinical Development Program Lead, Clinical Delivery - EMP
Eli Lilly and Company
September 03, 2026
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Purpose
- Lead creation and execution of exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical trials.
- Plan and deliver clinical trial and submission milestones on time and on budget across the molecule lifecycle.
- Own global clinical trial operations for the plan (single operational point of contact), including timeline creation/management, outsourcing, vendor management (operational deliverables), and budget management.
Responsibilities
- Develop phase 1 clinical asset strategy using quality decision-making principles.
- Provide clinical/regulatory document consultation (e.g., protocols, Investigator Brochures, risk profiles, NDAs, safety updates, CSRs, abstracts/publications).
- Maintain therapeutic area knowledge (disease/targets, competitors, trends) and operational requirements (e.g., FHD).
- Lead clinical project management processes/tools; oversee TPO-delivered trial deliverables.
- Manage clinical timelines/process maps; ensure progress communication.
- Manage molecule-level clinical budget with change control; assess/mitigate clinical risks.
- Oversee clinical delivery: implementation timelines, vendor selection/oversight, global issue resolution, safety management with regulatory/medical.
- Communicate clearly across levels; document decisions/actions/metrics; ensure archival of clinical info.
Minimum Qualifications
- Bachelor’s degree in a science-related field.
- 3+ years in pharma managing clinical studies (exploratory and/or biopharmaceutics).
- Experience with clinical trial regulations/guidelines.
- Experience overseeing TPOs; project management tools/processes.
- Cross-cultural/virtual work experience; Word/Excel/PowerPoint/Microsoft Project.
- Travel up to 10%.
Preferred/Additional
- Advanced scientific degree; 5+ years pharma (exploratory/biopharmaceutics preferred).
- Vendor management/contracting; influence/relationship-building; coaching/mentoring; strong problem-solving.
Compensation/Benefits (if eligible)
- Anticipated pay: $117,000–$171,600; possible company bonus; 401(k), pension, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits.
Application instructions
- For accommodation requests, complete https://careers.lilly.com/us/en/workplace-accommodation.
- Lead creation and execution of exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical trials.
- Plan and deliver clinical trial and submission milestones on time and on budget across the molecule lifecycle.
- Own global clinical trial operations for the plan (single operational point of contact), including timeline creation/management, outsourcing, vendor management (operational deliverables), and budget management.
Responsibilities
- Develop phase 1 clinical asset strategy using quality decision-making principles.
- Provide clinical/regulatory document consultation (e.g., protocols, Investigator Brochures, risk profiles, NDAs, safety updates, CSRs, abstracts/publications).
- Maintain therapeutic area knowledge (disease/targets, competitors, trends) and operational requirements (e.g., FHD).
- Lead clinical project management processes/tools; oversee TPO-delivered trial deliverables.
- Manage clinical timelines/process maps; ensure progress communication.
- Manage molecule-level clinical budget with change control; assess/mitigate clinical risks.
- Oversee clinical delivery: implementation timelines, vendor selection/oversight, global issue resolution, safety management with regulatory/medical.
- Communicate clearly across levels; document decisions/actions/metrics; ensure archival of clinical info.
Minimum Qualifications
- Bachelor’s degree in a science-related field.
- 3+ years in pharma managing clinical studies (exploratory and/or biopharmaceutics).
- Experience with clinical trial regulations/guidelines.
- Experience overseeing TPOs; project management tools/processes.
- Cross-cultural/virtual work experience; Word/Excel/PowerPoint/Microsoft Project.
- Travel up to 10%.
Preferred/Additional
- Advanced scientific degree; 5+ years pharma (exploratory/biopharmaceutics preferred).
- Vendor management/contracting; influence/relationship-building; coaching/mentoring; strong problem-solving.
Compensation/Benefits (if eligible)
- Anticipated pay: $117,000–$171,600; possible company bonus; 401(k), pension, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits.
Application instructions
- For accommodation requests, complete https://careers.lilly.com/us/en/workplace-accommodation.