Director, Oncology Clinical Pharmacology & Modeling

GlaxoSmithKline; Upper Providence (Delaware County); Ibrido; USD 188.000 - 314.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Long term incentive

Health care

Retirement benefits

Paid holidays

Descrizione del lavoro

GlaxoSmithKline is seeking a Director for CPMS Oncology to advance model-informed drug development across small molecules, biologics, and ADCs within Oncology Translational Medicine. The role blends clinical pharmacology and M&S, with responsibilities spanning study design, dose prediction, and regulatory interactions.

The position offers hybrid work with 2-3 days in the office and opportunities to influence development decisions through quantitative methods and collaborations with

Competenze

• PhD or MD in Pharmaceutical Sciences or related field.
• 5+ years experience in clinical pharmacology and modelling.
• Experience with PK/PD modeling and pharmacometric tools.
• Familiar with FDA/ICH guidelines in study design.

Mansioni

• Design efficient clinical development programs and robust registration packages.
• Predict human dose range and characterize exposure-response.
• Develop models to understand disease progression and PK/PD.
• Present strategy and outcomes of model-based approaches with teams and regulators.
• Write protocols and regulatory submission documents.
• Apply FDA and ICH guidelines in study design.

Conoscenze

Clinical pharmacology

Modeling & simulation

PK/PD principles

Regulatory guidelines

Formazione

PhD in Pharmaceutical Sciences

MD in Medicine

PharmD or Master’s degree

Strumenti

NONMEM

Monolix

R

Descrizione del lavoro

GlaxoSmithKline is seeking a Director for CPMS Oncology to advance model-informed drug development across small molecules, biologics, and ADCs within Oncology Translational Medicine. The role blends clinical pharmacology and M&S, with responsibilities spanning study design, dose prediction, and regulatory interactions.

The position offers hybrid work with 2-3 days in the office and opportunities to influence development decisions through quantitative methods and collaborations with