Oncology CPMS Director: Model-Informed Drug Development

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

Vantaggi offerti da questo lavoro

Health care benefits

Retirement benefits

Paid leave

Descrizione del lavoro

GlaxoSmithKline plc is seeking a Director in Oncology CPMS to lead clinical pharmacology and modeling in drug development. You will design dose-ranging studies, develop PK/PD models, and collaborate with cross-functional teams to influence oncology programs.

The role emphasizes MID3 approaches, regulatory interactions, and advancing model-based decision making within a hybrid work setting (2–3 days in the office). A PhD/MD with 5+ years in the field is expected.

Competenze

• Advanced training with a PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine or related field.
• 5+ years’ experience leveraging clinical pharmacology and modeling in drug development.
• 5+ years’ experience applying PK/PD principles and pharmacometric models.
• 5+ years’ experience using tools for quantitative clinical pharmacology such as NONMEM, Monolix, or R.

Mansioni

• Lead activities to progress clinical pharmacology and modeling in oncology programs.
• Predict human dose range, characterize exposure-response, justify dose for later studies.
• Design/interpret PK/PD studies; develop models to understand disease progression and drug effects.
• Conduct meta-analyses and simulations to inform trial design and investment decisions.
• Present MID3 strategies to project teams and regulators; write protocols and reports.

Conoscenze

Drug Design

Drug Development

Pharmacodynamics

Pharmacokinetics

Pharmacology

Pharmacometrics

Molecular Modeling

Regulatory Compliance

Medication Safety

Study Design

Formazione

PhD or MD in Pharmaceutical Sciences (or related)

PharmD or Master’s in related field + 4 years experience

Strumenti

NONMEM

Monolix

R

Descrizione del lavoro

GlaxoSmithKline plc is seeking a Director in Oncology CPMS to lead clinical pharmacology and modeling in drug development. You will design dose-ranging studies, develop PK/PD models, and collaborate with cross-functional teams to influence oncology programs.

The role emphasizes MID3 approaches, regulatory interactions, and advancing model-based decision making within a hybrid work setting (2–3 days in the office). A PhD/MD with 5+ years in the field is expected.