Lead, Oncology Clinical Pharmacology Modeling & Simulation

GlaxoSmithKline; Durham (NC); Hybrid; USD 150,000 - 250,000; Full time

Job summary

GSK in the United States is seeking a highly skilled quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation group. You will work across small molecules, biologics, and antibody‑drug conjugates to inform development decisions.

This hybrid role offers collaboration with cross‑functional teams and opportunities to influence regulatory submissions and labeling through model‑informed drug development.

Qualifications

• A doctorate (PharmD, PhD, MD) or master's degree in quantitative clinical pharmacology and pharmacometrics.
• 2+ years of experience utilizing skills in population PK, exposure‑response, mechanistic PKPD and/or longitudinal disease modeling to solve practical problems in industry or academia.
• Experience in pharmacometric tools such as NONMEM, Monolix, and/or R.
• 2+ years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level.

Responsibilities

• Plan, conduct and report population pharmacokinetic modeling, exposure‑response analysis, simulation‑based trial design and dose selection.
• Apply innovative methods such as longitudinal exposure‑response analysis, model‑based meta‑analysis and quantitative systems pharmacology.
• Present strategy and defend outcomes of model‑based approaches to internal governance boards and regulatory agencies.
• Contribute to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions.
• Write or review clinical pharmacology components of regulatory documents and responses to support rapid and optimal labeling.

Skills

Population PK

Exposure–response

Modeling & simulation

Regulatory submissions

Education

PharmD/PhD/MD

Quantitative pharmacology

Tools

NONMEM

Monolix

R

Job description

GSK in the United States is seeking a highly skilled quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation group. You will work across small molecules, biologics, and antibody‑drug conjugates to inform development decisions.

This hybrid role offers collaboration with cross‑functional teams and opportunities to influence regulatory submissions and labeling through model‑informed drug development.