Associate Director, Oncology Modeling & Simulation

Women In Bio; Collegeville (PA); Hybrid; USD 148,000 - 246,000; Full time

Benefits offered by this job

Annual bonus

Health care benefits

Retirement benefits

Paid holidays

Vacation leave

Paid caregiver/parental and medical/di

Job summary

GSK is seeking a highly motivated quantitative clinical pharmacologist to join the Oncology CPMS group within Oncology Translational Medicine. The role spans from pre‑FTIH to submission and lifecycle management, with hybrid work on‑site 2–3 days/week.

The candidate will lead population PK, exposure‑response and model‑based analyses across small molecules, biologics and novel modalities, contributing to program design and regulatory interactions.

Qualifications

• A doctorate (PharmD, PhD, MD) or master's degree in quantitative clinical pharmacology and pharmacometrics disciplines (e.g., pharmacology, engineering or statistics)
• 2+ years of experience utilizing skills in population PK, exposure‑response, mechanistic PKPD and/or longitudinal disease modeling to solve practical problems in industry or academia
• Experience in pharmacometric tools such as NONMEM, Monolix, and/or R
• 2+ years of experience in the design, analysis, interpretation and reporting of clinical pharmacology studies per industry and regulatory standards for associate director level.

Responsibilities

• Planning, conducting and reporting population pharmacokinetic modeling, exposure‑response analysis, simulation‑based trial design and dose selection, and drug‑disease modeling
• Applying innovative methods such as longitudinal exposure‑response analysis, model‑based meta‑analysis and quantitative systems pharmacology to enhance data use and trial efficiency
• Presenting strategy and defending outcome of model‑based approaches to internal governance boards and regulatory agencies
• Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
• Write or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labeling (with regards to the clinical pharmacology, modeling and simulation contents)
• Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modeling and simulation contributions to the R&D pipeline
• Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
• Promoting model‑informed drug discovery and development through external collaboration, journal publication and conference presentation

Skills

Artificial Intelligence

Clinical Development

Drug Development

Drug Discovery Research

Modeling Simulations

Nonlinear Mixed Effects Modeling

Pharmacokinetics

Pharmacodynamics

Pharmacometrics

Regulatory Compliance

Education

Doctorate (PharmD, PhD, MD) or master's degree in quantitative clinical pharmacology/pharmacometrics

Tools

NONMEM

Monolix

R

Job description

GSK is seeking a highly motivated quantitative clinical pharmacologist to join the Oncology CPMS group within Oncology Translational Medicine. The role spans from pre‑FTIH to submission and lifecycle management, with hybrid work on‑site 2–3 days/week.

The candidate will lead population PK, exposure‑response and model‑based analyses across small molecules, biologics and novel modalities, contributing to program design and regulatory interactions.