Lead Quantitative Clinical Pharmacologist (PK/PD)

BioSpace; Indianapolis (IN); On-site; USD 153,000 - 246,000; Full time

Job summary

Lilly in Indianapolis seeks a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership on project teams and drive model-based decision making across our portfolio. You will work with PBPK, QSP and Pharmacometrics modelers to influence development strategies and regulatory submissions.

Ideal candidates have a PhD in a relevant field, 2+ years in drug development, and strong expertise in PK/PD, pharmacometrics, and NONMEM/Monolix/R.

Qualifications

• PhD in a pharmaceutical sciences or related field.
• Minimum 2 years of drug development and regulatory experience.
• Strong knowledge of PK/PD, pharmacometrics and model-informed drug development.
• Hands-on experience with nonlinear mixed-effect modeling and PBPK tools.

Responsibilities

• Provide PK/PD leadership to project teams to optimize dose, patient population and strategy.
• Collaborate with PBPK, QSP and Pharmacometrics modelers to inform portfolio decisions.
• Conduct exploratory PK/PD analyses in early development.
• Lead and support protocols, analysis plans, data interpretation and study reports for Phase I–III.
• Prepare INDs, IBs, CTDs and regulatory documents; interact with FDA/EMA as needed.
• Mentor scientists and represent the group in external forums and publications.

Education

PhD in Pharmaceutical Sciences

Tools

NONMEM

Monolix

R

SimCYP

GastroPlus

PK-Sim

Job description

Lilly in Indianapolis seeks a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership on project teams and drive model-based decision making across our portfolio. You will work with PBPK, QSP and Pharmacometrics modelers to influence development strategies and regulatory submissions.

Ideal candidates have a PhD in a relevant field, 2+ years in drug development, and strong expertise in PK/PD, pharmacometrics, and NONMEM/Monolix/R.