Director CPMS Oncology

Role Summary

Director CPMS Oncology responsible for delivering CPMS quantitative excellence to oncology development programs, guiding model-based development strategies and ensuring optimal patient, dose, and timing through clinical pharmacology modeling and simulation. Works within Oncology Translational Medicine across small molecules, biologics, and antibody drug conjugates; requires on-site presence 2–3 days per week.

Responsibilities

• Defining and executing model-based development strategies for oncology projects
• Planning, conducting and reporting exposure‚Äìresponse analysis, simulation-based trial design and dose selection, and population PK modelling
• Applying innovative methods such as drug‚Äìdisease modeling, longitudinal exposure‚Äìresponse 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, efficient approvals with optimal labeling
• Implement best practices and lessons learned to advance clinical pharmacology modeling 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 disciplines (e.g., pharmacology, engineering or statistics); or PharmD/Master with additional relevant experience
• Required: 5+ years in mechanistic PKPD and longitudinal disease modelling; proficiency in NONMEM or R
• Required: 3+ years of experience in 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 and trial design
• Knowledge of mechanisms/endpoints/treatments of cancers; ability to rapidly learn new cancer-related concepts
• Ability to adopt new modeling approaches to inform drug development; experience with AI/ML in pharmacometrics is a plus
• Proven collaboration skills in a multi-discipline team; strong communication and accountability
• Ability to prioritize multiple tasks and adapt to changing business needs
• Experience in design, analysis, interpretation and reporting of Clinical Pharmacology studies per regulatory standards
• Passion for quantitative clinical pharmacology and innovation
• Oncology R&D experience is a plus; experience with senior stakeholders in cross-functional environments
• Excellent interpersonal, oral/written communication and presentation skills
• Strong track record of implementing MID3 approaches to accelerate patient access and expand indications

Education

• PhD in Quantitative Clinical Pharmacology/Pharmacometrics or related field; or PharmD/Master with substantial relevant experience

Additional Requirements

• On-site presence required 2‚Äì3 days per week