Oncology Clinical Pharmacology & Modeling Lead

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

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation time

Parental leave

Medical leave

Job summary

GSK in the United States seeks a highly qualified quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group. You will drive population PK modeling, exposure–response analyses, and model-based trial design.

The role spans from pre-FTIH to submission and lifecycle management, with hybrid on-site work 2–3 days per week. The candidate should have a PhD/PharmD/MD with 2+ years in pharmacometrics, familiarity with NONMEM/Monolix/R, and

Qualifications

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

Responsibilities

• Plan, conduct, and report population PK modeling and exposure–response analyses; design dose–selection studies.
• Apply longitudinal exposure–response analysis and model-based meta-analysis to improve trial efficiency.
• Present model-based strategy to governance boards and regulatory agencies.
• Contribute to clinical program design, protocols, analysis plans, and regulatory submissions.
• Write/review clinical pharmacology sections of regulatory documents to support labeling.
• Implement best practices to advance modeling contributions to the R&D pipeline.
• Interact with management and external contacts on strategic and tactical levels.
• Promote model-informed drug development through external collaboration and publications.

Skills

Clinical Pharmacology

Modeling & Simulation

Pharmacokinetics

Pharmacodynamics

Pharmacometrics

Regulatory Compliance

Oncology

AI/ML in pharmacometrics

Education

PhD in quantitative pharmacology

PharmD or MD degree

Tools

NONMEM

Monolix

R

Job description

GSK in the United States seeks a highly qualified quantitative clinical pharmacologist to join the Oncology Clinical Pharmacology Modeling and Simulation (CPMS) group. You will drive population PK modeling, exposure–response analyses, and model-based trial design.

The role spans from pre-FTIH to submission and lifecycle management, with hybrid on-site work 2–3 days per week. The candidate should have a PhD/PharmD/MD with 2+ years in pharmacometrics, familiarity with NONMEM/Monolix/R, and