Senior Oncology Clinical Pharmacology Modeling Lead

GlaxoSmithKline; Waltham (MA); Hybrid; USD 148,000 - 246,000; Full time

Job summary

GSK in the United States is seeking a highly motivated quantitative clinical pharmacologist to join the Oncology CPMS within the Oncology Translational Medicine team. The role supports modeling, simulation, and decision-making from early development through lifecycle management.

You will work across small molecules, biologics and other modalities in a science-driven environment, collaborating with regulatory and cross-functional teams to drive impactful outcomes.

Qualifications

• Doctorate (PharmD, PhD, MD) or master's in quantitative clinical pharmacology/pharmacometrics disciplines.
• 2+ years of experience in population PK, exposure-response, mechanistic PKPD or longitudinal disease modeling.
• Experience with pharmacometric tools such as NONMEM, Monolix, and/or R.
• 2+ years of experience in design, analysis, interpretation and reporting of clinical pharmacology studies per industry standards.

Responsibilities

• Lead population pharmacokinetic modeling, exposure-response analyses, simulation-based trial design and dose selection.
• Apply model-informed drug development and quantitative systems pharmacology techniques.
• Present strategy and defend model-based outcomes to governance boards and regulators.
• Contribute to clinical program design, protocols, analysis plans and regulatory submissions.
• Draft or review clinical pharmacology components of regulatory documents to support rapid approval and optimal labeling.
• Advance best practices to enhance modeling and simulation contributions to R&D pipeline.
• Interact with management and external contacts on strategic/tactical levels.
• Promote MIDD through collaborations, publications and conferences.

Skills

Population PK

Exposure-Response

Monolix

NONMEM

R

Clinical pharmacology

Pharmacometrics

MIDD

AI/ML

Regulatory submissions

Education

PhD/MD/PharmD or Master's in quantitative clinical pharmacology

Tools

NONMEM

Monolix

R

Job description

GSK in the United States is seeking a highly motivated quantitative clinical pharmacologist to join the Oncology CPMS within the Oncology Translational Medicine team. The role supports modeling, simulation, and decision-making from early development through lifecycle management.

You will work across small molecules, biologics and other modalities in a science-driven environment, collaborating with regulatory and cross-functional teams to drive impactful outcomes.