Senior Clinical Pharmacology Modeling & Simulation Lead

GlaxoSmithKline; Waltham (MA); Hybrid; USD 183,000 - 305,000; Full time

Benefits offered by this job

Annual bonus

Healthcare programmes

Pension plan

Shares and savings programme

Hybrid work model

Job summary

GlaxoSmithKline seeks a senior quantitative clinical pharmacologist to lead modelling and simulation for infectious disease assets. You will combine hands-on pharmacometrics with strategic leadership, supporting early development through lifecycle management in a hybrid US-based role.

You will design and interpret studies, apply PBPK/PK–PD methods, and contribute to regulatory submissions while collaborating across clinical, regulatory and biostatistics teams.

Qualifications

• Advanced degree in life sciences (PhD/PharmD/MD) supporting quantitative pharmacology work.
• Substantial experience in human clinical pharmacology, PK, modelling & simulation and model-informed drug development.
• Hands-on experience applying population PK, PK/PD or exposure–response models to clinical questions.
• Experience with quantitative tools (NONMEM/Monolix, R) to inform development strategies.
• Experience contributing to regulatory interactions and regulatory documents.

Responsibilities

• Lead activities to progress clinical pharmacology strategies for infectious disease assets.
• Apply PK/PD and modelling to support development, risk management and lifecycle decisions.
• Characterise dose selection and dosing regimens using exposure-response analyses.
• Develop and apply population PK/PK–PD models and run simulations for trial design.
• Present strategy and model-based evidence to governance and regulatory teams.
• Collaborate with cross-functional teams and external partners; provide hands-on analyses.

Skills

Clinical pharmacology

PK/PD modelling

Model-informed development

NONMEM/Monolix

R

Regulatory interactions

Education

PhD/PharmD/MD in life sciences

Tools

NONMEM

Monolix

R

Job description

GlaxoSmithKline seeks a senior quantitative clinical pharmacologist to lead modelling and simulation for infectious disease assets. You will combine hands-on pharmacometrics with strategic leadership, supporting early development through lifecycle management in a hybrid US-based role.

You will design and interpret studies, apply PBPK/PK–PD methods, and contribute to regulatory submissions while collaborating across clinical, regulatory and biostatistics teams.