Senior Clinical PK/PD Project Leader

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 153,000 - 246,000; Full time

Benefits offered by this job

Bonus potential

401(k)

Health, dental, vision benefits

Vacation benefits

Well-being programs

Job summary

Lilly is seeking a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership on project teams and drive model-based decision-making across our portfolio. You will collaborate with PBPK, QSP, and Pharmacometrics modelers to deliver quantitative insights that shape development strategies across multiple geographies.

The role involves leading study protocols, analysis plans, and regulatory filings (INDs/CTDs), with opportunities to mentor colleagues and contribute to publications.

Qualifications

• PhD in Pharmaceutical Sciences or related field with drug development/regulatory exposure.
• 2+ years of relevant experience in Quantitative Clinical Pharmacology, PK/PD, or Pharmacometrics.

Responsibilities

• Provide PK/PD leadership to project teams to support dose and development strategy.
• Collaborate with PBPK, QSP, and PM modelers to inform portfolio decisions.
• Conduct exploratory PK/PD analyses in early development stages.
• Drive data-driven decision-making and solutions for drug development challenges.
• Lead PK/PD aspects of study plans and analysis reports across phases I–III.
• Prepare regulatory documents (INDs, IBs, CTDs) and interact with agencies as needed.

Skills

PK/PD leadership

Quantitative pharmacology

MIDD approaches

PBPK/QSP/PM modeling

NONMEM/Monolix/R

Education

PhD in Pharmaceutical Sciences or related

2+ years in drug development/regulatory

Tools

NONMEM

Monolix

R

SimCYP

GastroPlus

Job description

Lilly is seeking a dynamic Quantitative Clinical Pharmacologist to provide PK/PD leadership on project teams and drive model-based decision-making across our portfolio. You will collaborate with PBPK, QSP, and Pharmacometrics modelers to deliver quantitative insights that shape development strategies across multiple geographies.

The role involves leading study protocols, analysis plans, and regulatory filings (INDs/CTDs), with opportunities to mentor colleagues and contribute to publications.