Director, Oncology Clinical Pharmacology & Modeling

GlaxoSmithKline; Durham (NC); Hybrid; USD 188,000 - 314,000; Full time

Job summary

GSK in the United States seeks a Director to lead the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) team within Oncology Translational Medicine. This role blends clinical pharmacology and modelling to guide model-informed drug development across our R&D portfolio, helping to reach the right patients with the right dose at the right time.

Hybrid setting: office presence 2–3 days per week. You will design development programs, predict dose ranges, develop PK/PD models, and drive

Qualifications

• PhD or MD in Pharmaceutical Sciences or related field; PharmD/Master with 4 years experience may be considered.
• 5+ years' experience leveraging clinical pharmacology and modelling in drug development.
• 5+ years' experience applying PK/PD principles and pharmacometric models.
• 5+ years' experience using quantitative clinical pharmacology tools (NONMEM, Monolix, R).
• Experience applying FDA/ICH guidelines in trial design and drug development.

Responsibilities

• Contribute to design of efficient clinical development programs and robust registration packages.
• Predict human dose range and exposure–response relationships; justify dose recommendations.
• Design and interpret clinical pharmacology studies to evaluate factors affecting PK/PD.
• Develop mathematical models to understand disease progression and drug effects; conduct meta-analyses and simulations.
• Present CPMS strategy and outcomes of model-based approaches to project teams and regulators.
• Write sections of development and regulatory documents such as protocols and reports.
• Apply FDA and ICH guidelines in study design and development strategy.
• Advocate for MID3 in teams and external collaborations; engage in publications and conferences.
• Collaborate with cross-functional teams and external groups to advance methodologies.

Skills

Clinical pharmacology

Pharmacometric modelling

MID3 concepts

Education

PhD or MD in Pharmaceutical Sciences

PharmD or Master with 4 years experience

Tools

NONMEM

Monolix

R

Job description

GSK in the United States seeks a Director to lead the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) team within Oncology Translational Medicine. This role blends clinical pharmacology and modelling to guide model-informed drug development across our R&D portfolio, helping to reach the right patients with the right dose at the right time.

Hybrid setting: office presence 2–3 days per week. You will design development programs, predict dose ranges, develop PK/PD models, and drive