Director, Oncology Clinical Pharmacology & M&S

NCBioImpact; Durham (NC); Ibrido; USD 188.000 - 314.000; Tempo pieno

Descrizione del lavoro

GSK is seeking a Director to lead the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) team within Oncology Translational Medicine. The role focuses on bringing model-informed drug development into R&D, guiding dose decisions across small molecules, biologics, and ADCs.

Hybrid work arrangement requires 2–3 days in the office. The successful candidate will drive design, analysis, and regulatory interactions to accelerate development while working with cross-functional teams and

Competenze

• Advanced degree in a relevant field
• Experience in clinical pharmacology and modeling for drug development
• Experience applying pharmacokinetic/pharmacodynamic models and quantitative PKPD approaches
• Familiarity with regulatory guidelines (FDA/ICH) and submission documents
• Experience designing clinical development programs and dose rationale

Mansioni

• Lead multi-disciplinary design of clinical development programs and robust registration packages
• Predict human dose range and characterize exposure–response relationships
• Design and interpret clinical pharmacology studies (PK/PD) for intrinsic/extrinsic factors
• Develop mathematical models to describe disease, progression, and drug effects; conduct meta-analyses and simulations
• Present CPMS strategy and model-based outcomes to project teams and regulators
• Prepare sections of drug development and regulatory submission documents
• Apply FDA/ICH guidelines to study design and development strategy
• Promote MID3 and collaboration through publications and conferences
• Collaborate across teams to improve program efficiency and decision quality
• Learn and apply new modeling methodologies for improved decision making

Conoscenze

Pharmacometrics

Pharmacokinetics

Clinical Pharmacology

Modeling & Simulation

Drug Discovery

Regulatory Submissions

FDA Guidelines

Formazione

PhD or MD in Pharmaceutical Sciences

Strumenti

NONMEM

Monolix

R

Descrizione del lavoro

GSK is seeking a Director to lead the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) team within Oncology Translational Medicine. The role focuses on bringing model-informed drug development into R&D, guiding dose decisions across small molecules, biologics, and ADCs.

Hybrid work arrangement requires 2–3 days in the office. The successful candidate will drive design, analysis, and regulatory interactions to accelerate development while working with cross-functional teams and