Director – Executive Director, PK/PD & Pharmacometrics (Level based on experience)
Eli Lilly and Company
August 19, 2026
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Role Overview
The Global PK/PD and Pharmacometrics Department serves as the functional leader in R&D across the value chain. The role supports accelerating innovative medicine development through mechanistic reasoning and quantitative modeling.
Main Responsibilities Include
- Provide PK/PD and quantitative clinical pharmacology scientific leadership to project teams (target, molecule, dose, patient population, development strategy).
- Conduct exploratory MIDD and PK/PD analysis across development stages.
- Anticipate drug development challenges and drive effective, data-driven decisions and solutions.
- Lead PK/PD aspects of program/product team plans; integrate quantitative approaches into discovery and/or development.
- Lead/support preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis/interpretation, and study reports.
- Prepare INDs, IBs, CTDs, and other regulatory documents across geographies; may involve interaction with FDA, EMA, PMDA, and other agencies.
- Communicate quantitative data and advocate for model-based decision making with cross-functional teams and senior stakeholders.
- Coach/mentor scientists; interact, teach, and collaborate with academia.
- Increase external visibility via key publications and leadership in scientific organizations/trade groups/consortia.
Basic Requirements
- PhD in a relevant discipline and at least 8 years of relevant PK/PD or Clinical Pharmacology experience.
Additional Skills & Preferences
- Strong understanding of PK, PD, pharmacometrics, and clinical pharmacology.
- Cross-functional collaboration and ability to communicate quantitative concepts to non-quantitative audiences.
- Excellent written and verbal communication.
- Regulatory interaction experience (FDA/EMA/PMDA or other agencies) preferred.
The Global PK/PD and Pharmacometrics Department serves as the functional leader in R&D across the value chain. The role supports accelerating innovative medicine development through mechanistic reasoning and quantitative modeling.
Main Responsibilities Include
- Provide PK/PD and quantitative clinical pharmacology scientific leadership to project teams (target, molecule, dose, patient population, development strategy).
- Conduct exploratory MIDD and PK/PD analysis across development stages.
- Anticipate drug development challenges and drive effective, data-driven decisions and solutions.
- Lead PK/PD aspects of program/product team plans; integrate quantitative approaches into discovery and/or development.
- Lead/support preparation and delivery of Phase I, II, and III study protocols, analysis plans, data analysis/interpretation, and study reports.
- Prepare INDs, IBs, CTDs, and other regulatory documents across geographies; may involve interaction with FDA, EMA, PMDA, and other agencies.
- Communicate quantitative data and advocate for model-based decision making with cross-functional teams and senior stakeholders.
- Coach/mentor scientists; interact, teach, and collaborate with academia.
- Increase external visibility via key publications and leadership in scientific organizations/trade groups/consortia.
Basic Requirements
- PhD in a relevant discipline and at least 8 years of relevant PK/PD or Clinical Pharmacology experience.
Additional Skills & Preferences
- Strong understanding of PK, PD, pharmacometrics, and clinical pharmacology.
- Cross-functional collaboration and ability to communicate quantitative concepts to non-quantitative audiences.
- Excellent written and verbal communication.
- Regulatory interaction experience (FDA/EMA/PMDA or other agencies) preferred.