Director of Oncology Clinical PK/PD Modeling & Simulation

GSK; Durham (NC); Hybride; USD 188 000 - 314 000; Plein temps

Avantages offerts par ce poste

Annual bonus

LTIP program

Health & other insurance

Retirement benefits

Paid holidays

Vacation

Parental and caregiver leave

Résumé du poste

GSK is seeking a Director to lead Oncology Clinical Pharmacology Modelling and Simulation (CPMS) within Oncology Translational Medicine. You will drive model-based drug development, predict dose ranges, and shape regulatory submissions.

Hybrid work involves 2–3 days in the office and collaboration across matrices. You will apply FDA/ICH guidelines, build advanced PK/PD models, and influence development decisions through data-driven insights, contributing to life-cycle management of oncology

Qualifications

• Advanced degree in pharmaceutical sciences or related field with relevant experience.
• 5+ years using clinical pharmacology and modeling in drug development.
• Experience applying PK/PD principles and pharmacometric models.
• Experience with FDA/ICH guidelines in study design and development.
• Strong collaboration across multi-disciplinary teams.

Responsabilités

• Lead activities in design of clinical development programs and registration packages.
• Predict human dose range and justify dose recommendations for later studies.
• Design and interpret pharmacology studies; evaluate intrinsic/extrinsic factors.
• Develop models to understand disease progression and drug PK/PD; run simulations.
• Present CPMS strategy to project teams and regulators; contribute to submissions.

Connaissances

PhD/MD in pharma sci

Clinical pharmacology

Modeling & simulation

NONMEM/Monolix/R

FDA/ICH guidelines

Formation

PhD or MD in Pharmaceutical Sciences

Outils

NONMEM

Monolix

R

Description du poste

GSK is seeking a Director to lead Oncology Clinical Pharmacology Modelling and Simulation (CPMS) within Oncology Translational Medicine. You will drive model-based drug development, predict dose ranges, and shape regulatory submissions.

Hybrid work involves 2–3 days in the office and collaboration across matrices. You will apply FDA/ICH guidelines, build advanced PK/PD models, and influence development decisions through data-driven insights, contributing to life-cycle management of oncology