Clinical Trial Program Lead
Eli Lilly and Company
September 03, 2026
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Clinical Trial Program Lead
Role Purpose and Overview
- Lead creation and execution of exploratory and biopharmaceutics clinical development plans at a molecule level, providing technical leadership and operational oversight of clinical research trials.
- Plan and deliver exploratory/biopharmaceutics milestones on time and on budget across the molecule lifecycle.
- Own global clinical trial operations within the plan as the single operational point of contact from trial design through close out: timeline creation/management, outsourcing and vendor management, patient recruitment/retention, and budget management.
Main Responsibilities
- Scientific/Therapeutic Expertise: Lead Phase 1 asset strategy using quality decision-making; understand therapeutic area, trial design, risks, and best practices; advise on clinical/regulatory documents (protocols, IBs, NDAs, CSRs); stay current on disease and industry trends; understand operational needs for early-phase studies.
- Clinical Project Management: Lead processes/tools; collaborate with TPOs; maintain timelines and stakeholder communications; manage budgets and change processes; identify and mitigate risks.
- Clinical Operations: Oversee trial operations to meet timelines/budgets; lead planning/execution; select and manage vendors; act as main contact resolving issues and managing risks; partner with regulatory/medical teams on safety processes.
- Communication/Leadership: Document key decisions/metrics; lead governance interactions; communicate across levels; collaborate in a matrix; solve problems, negotiate, foster innovation; mentor.
Essential Requirements
- Bachelor’s degree in a science-related field.
- Few years’ pharmaceutical experience managing clinical studies; few years managing Phase 1 (exploratory and biopharmaceutics).
- Vendor/contract management; strong knowledge of clinical trial regulations/guidelines.
- Proficient Microsoft Office (Word/Excel/PowerPoint/Project) and end-user computing.
- Skilled managing TPOs; experienced with project management tools/methodologies.
- Willing to travel up to 10%.
Role Purpose and Overview
- Lead creation and execution of exploratory and biopharmaceutics clinical development plans at a molecule level, providing technical leadership and operational oversight of clinical research trials.
- Plan and deliver exploratory/biopharmaceutics milestones on time and on budget across the molecule lifecycle.
- Own global clinical trial operations within the plan as the single operational point of contact from trial design through close out: timeline creation/management, outsourcing and vendor management, patient recruitment/retention, and budget management.
Main Responsibilities
- Scientific/Therapeutic Expertise: Lead Phase 1 asset strategy using quality decision-making; understand therapeutic area, trial design, risks, and best practices; advise on clinical/regulatory documents (protocols, IBs, NDAs, CSRs); stay current on disease and industry trends; understand operational needs for early-phase studies.
- Clinical Project Management: Lead processes/tools; collaborate with TPOs; maintain timelines and stakeholder communications; manage budgets and change processes; identify and mitigate risks.
- Clinical Operations: Oversee trial operations to meet timelines/budgets; lead planning/execution; select and manage vendors; act as main contact resolving issues and managing risks; partner with regulatory/medical teams on safety processes.
- Communication/Leadership: Document key decisions/metrics; lead governance interactions; communicate across levels; collaborate in a matrix; solve problems, negotiate, foster innovation; mentor.
Essential Requirements
- Bachelor’s degree in a science-related field.
- Few years’ pharmaceutical experience managing clinical studies; few years managing Phase 1 (exploratory and biopharmaceutics).
- Vendor/contract management; strong knowledge of clinical trial regulations/guidelines.
- Proficient Microsoft Office (Word/Excel/PowerPoint/Project) and end-user computing.
- Skilled managing TPOs; experienced with project management tools/methodologies.
- Willing to travel up to 10%.