Director CPMS Oncology

Role Summary

Director CPMS Oncology at GSK. Delivering CPMS quantitative excellence to Oncology Translational Medicine programs to inform and accelerate development of oncology therapies, ensuring patients receive the right dose 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 such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
• Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
• Ability to interact with line and middle management, staff and external contacts on a functional, strategic and tactical level
• Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation

Qualifications

• Required: PhD in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) with experience using modelling/simulation; PharmD or Master with additional 4 years of 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 Qualifications

• Strong drive and learning agility to build knowledge on drug-disease systems, symptom progression, and trial design
• Knowledge of mechanism, endpoints, progression and treatments of cancers; ability to learn quickly
• Ability to adopt new modeling approaches to inform drug development; experience with AI/ML tools in pharmacometrics a plus
• Collaborative with effective communication and accountability for timely delivery
• Ability to prioritize multiple tasks and adapt to changing business needs
• Experience in design, analysis, interpretation and reporting of Clinical Pharmacology studies per standards
• Passion for quantitative clinical pharmacology and innovation
• Oncology R&D experience a plus; experience with senior stakeholders in cross-functional environments
• Excellent interpersonal, oral/written communication and presentation skills
• Proven track record in MID3 approaches to accelerate patient access and expand indications

Education

• PhD in Quantitative Clinical Pharmacology/Pharmacometrics or related field; or PharmD/Master with applicable experience as noted

Additional Requirements

• On-site presence 2-3 days per week