Senior Quantitative PK/PD Project Leader

BioSpace

Indianapolis (IN)

On-site

USD 153,000 - 246,000

Full time

2 days ago
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Benefits offered by this job

Company bonus
401(k) plan
Pension
Medical insurance
Dental insurance
Vision insurance
Vacation benefits

Job summary

Lilly in Indianapolis seeks a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership and drive model-based decision-making across the portfolio. You will guide dose selection, patient population, and development strategy with cross-functional teams worldwide.

You will collaborate with PBPK, QSP, and Pharmacometrics modelers to deliver quantitative insights, lead PK/PD analyses, and contribute to regulatory submissions and publications.

Qualifications

  • PhD in Pharmaceutical Sciences or related discipline required.
  • Minimum 2 years drug development/regulatory experience in quantitative PK/PD, PBPK, or Pharmacometrics.

Responsibilities

  • Provide PK/PD leadership to project teams for dose selection and strategy.
  • Collaborate with PBPK, QSP, and Pharmacometrics modelers.
  • Lead and conduct exploratory PK/PD analyses in early development.
  • Deliver study protocols, analysis plans, and reports across Phase I–III.

Skills

Pharmacokinetics
Clinical pharmacology
MIDD approaches
Communication
Collaboration

Education

PhD in Pharmaceutical Sciences

Tools

NONMEM
Monolix
R
SimCYP
GastroPlus
PK-Sim
MATLAB

Job description

Lilly in Indianapolis seeks a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership and drive model-based decision-making across the portfolio. You will guide dose selection, patient population, and development strategy with cross-functional teams worldwide.

You will collaborate with PBPK, QSP, and Pharmacometrics modelers to deliver quantitative insights, lead PK/PD analyses, and contribute to regulatory submissions and publications.

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