Director CPMS Oncology

Role Summary

Director CPMS Oncology at GSK, leading the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. Focuses on delivering CPMS quantitative excellence to development programs, informing and accelerating the development of oncology therapies to reach the right patients, at the right dose, and at the right time. On-site presence 2-3 days per week.

Responsibilities

• Defining and executing model-based development strategies for oncology projects
• Planning, conducting and reporting exposure-response analysis, simulation-based trial design and dose selection, and population PK modelling
• Applying innovative methods such as drug-disease modeling, longitudinal exposure-response analysis, model-based meta-analysis, quantitative systems pharmacology and AI/ML informed analyses 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 to enable rapid and efficient approvals with optimum labelling
• Implement best practices and lessons learned to advance clinical pharmacology modelling and simulation contributions to R&D pipeline
• Interact with line and middle management, staff and external contacts on functional, strategic and tactical levels
• Promote model-informed drug discovery and development through external collaboration, journal publication and conference presentation

Qualifications

• Required: PhD in Quantitative Clinical Pharmacology and Pharmacometrics (e.g., pharmacology, engineering or statistics) with experience in modelling/simulation; PharmD or Master with additional relevant experience may be considered
• Required: 5+ years in mechanistic PKPD and longitudinal disease modelling; proficiency in NONMEM or R
• Required: 3+ years planning, performing, and reporting analysis of clinical data per industry and regulatory standards
• Preferred: Knowledge of or ability to learn cancer mechanisms, endpoints, progression and treatments; experience with AI/ML tools in pharmacometrics; collaboration in multi-disciplinary teams; strong communication and stakeholder management

Skills

• Model-informed drug discovery and development (MID3)
• Clinical pharmacology and modelling & simulation excellence
• Exposure-response analysis and dose selection
• AI/ML informed analyses; quantitative systems pharmacology
• Regulatory writing and submissions; cross-functional collaboration

Education

• PhD in Quantitative Clinical Pharmacology and Pharmacometrics (or equivalent); alternative with PharmD or Master plus experience