Director, Oncology Clinical Pharmacology MIDD AI/ML
Core
Lead quantitative clinical pharmacology and modelling & simulation (CPMS) strategies for oncology development programs to inform drug development, dosing, and trial design.
Role type
Director, Oncology Clinical Pharmacology MIDD AI/ML
Builds
Model-based development strategies, exposure-response analyses, simulation-based trial designs, and regulatory submissions for oncology therapies.
Domain
Biopharmaceuticals, Oncology, Clinical Pharmacometrics, AI/ML in Drug Development
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
Quantitative clinical pharmacology, Pharmacometrics, Mechanistic PKPD modelling, Longitudinal disease modelling, NONMEM, R, AI/ML in clinical pharmacology, Regulatory standards compliance, Model-based meta-analysis, Quantitative systems pharmacology
Preferred skills
Drug-disease system knowledge, Cancer mechanism understanding, New modeling approach implementation, Cross-functional collaboration, Strategic stakeholder management, MIDD approach implementation
Technologies
NONMEM, R
Responsibilities
Define and execute model-based development strategies; Plan, conduct, and report exposure-response analysis and simulation-based trial design; Apply AI/ML informed analyses to enhance data use; Present strategy to governance boards and regulatory agencies; Contribute to clinical program design and regulatory submissions; Implement best practices for clinical pharmacology modelling; Collaborate with line and middle management; Promote model-informed drug discovery through external collaboration and publications.
Seniority
Director, strategic leadership with hands-on technical expertise
