Director CPMS Oncology

Role Summary

Director CPMS Oncology — supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. Responsible for delivering CPMS quantitative excellence to development programs in oncology, ensuring therapies reach the right patients, at the right dose, and at the right time. On-site presence required 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 outcomes 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 support rapid and efficient labeling
• Implement best practices and lessons learned to advance clinical pharmacology modelling and simulation contributions to the 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 4 years of relevant experience may be considered
• Required: 5+ years of mechanistic PKPD and longitudinal disease modelling; proficiency in NONMEM or R
• Required: 3+ years of experience planning, performing, and reporting analysis of clinical data per industry and regulatory standards
• Preferred: Strong drive and learning agility to understand drug-disease systems, cancer mechanisms and trial design
• Preferred: Knowledge of cancer mechanisms, endpoints, progression and treatments; ability to learn new modelling approaches; experience with AI/ML in pharmacometrics
• Preferred: Collaboration skills in multi-discipline teams, accountability for timely results, ability to prioritize multiple tasks, and strong communication
• Preferred: Experience in Oncology R&D and working with senior stakeholders in cross-functional environments; excellent interpersonal and presentation skills; track record of MID3 approaches

Education

• PhD in Quantitative Clinical Pharmacology and Pharmacometrics (or related field); consideration given to PharmD or Master with equivalent experience

Skills

• Model-informed drug discovery and development (MID3)
• Pharmacometric tools (NONMEM, R)
• Exposure-response analysis, population PK/PD
• Drug-disease modeling, meta-analysis, quantitative systems pharmacology
• AI/ML applications in pharmacometrics
• Regulatory writing and submissions
• Cross-functional collaboration and communication

Additional Requirements

• On-site presence 2-3 days per week