Senior Clinical Pharmacology & Modeling Lead

Women In Bio; Collegeville (PA); Hybrid; USD 183,000 - 305,000; Full time

Benefits offered by this job

Healthcare

Pension plan

Share and savings programme

Hybrid work model

Job summary

GSK is seeking a hands‑on Quantitative Clinical Pharmacologist to lead Clinical Pharmacology, Modeling and Simulation for infectious disease assets. The role combines hands‑on pharmacometrics with strategic leadership, contributing to early planning, late‑stage development and lifecycle management.

Hybrid US role with on‑site and remote collaboration, available for occasional Stevenage basis relocation as noted.

Qualifications

• Advanced degree in a relevant life science discipline (PhD/PharmD/MD).
• Substantial experience in human clinical pharmacology, PK, modelling & simulation and model‑informed drug development.
• Hands‑on experience with population PK, PK/PD or exposure‑response models.
• Experience with quantitative clinical pharmacology tools (NONMEM/Monolix, R).
• Experience contributing to regulatory interactions or submission documents.

Responsibilities

• Act as the Clinical Pharmacology, Modeling and Simulation representative on cross‑functional medical development teams.
• Apply PK/PD and modelling principles to support clinical development, risk management, and lifecycle management.
• Characterise exposure‑response relationships and dosing recommendations for patient populations.
• Develop and apply population PK/PKPD models and conduct simulations to inform trial design.
• Present model‑based evidence to governance boards, development teams and regulatory agencies.
• Apply regulatory guidance to clinical pharmacology plans and study designs.
• Advance model‑informed drug development through collaboration and external engagement.
• Design and interpret clinical pharmacology studies evaluating PK/PD factors.
• Identify opportunities to apply PBPK and in silico approaches for drug interactions and special populations.
• Author and contribute to clinical development and regulatory documents.

Skills

Clinical pharmacology

Pharmacokinetics

Modeling & simulation

Population PK

NONMEM

Monolix

R

Regulatory interactions

Education

PhD/PharmD/MD

Tools

Python

WinNonlin

Simcyp

SAS

MATLAB

PBPK

Job description

GSK is seeking a hands‑on Quantitative Clinical Pharmacologist to lead Clinical Pharmacology, Modeling and Simulation for infectious disease assets. The role combines hands‑on pharmacometrics with strategic leadership, contributing to early planning, late‑stage development and lifecycle management.

Hybrid US role with on‑site and remote collaboration, available for occasional Stevenage basis relocation as noted.