Director, Oncology Clinical Pharmacology Modeling & Simulation

What you'll do

• Design clinical development programs and clinical pharmacology studies, and recommend doses using exposure-response analyses.
• Develop pharmacometric models and simulations to assess drug effects, disease progression, and trial designs.
• Communicate CPMS strategies and findings to project teams, governance boards, and regulatory agencies; contribute to development and registration documents.

What they ask for

• PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine, or a related field; a PharmD or Master’s in the same disciplines may be considered with 4 additional years of relevant experience.
• 5+ years’ experience leveraging clinical pharmacology and modeling in drug development.
• 5+ years’ experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models.
• 5+ years’ experience using quantitative clinical pharmacology tools such as NONMEM, Monolix, or R; experience applying FDA and ICH guidelines in clinical development plans and studies.

Nice to have

• Oncology drug development experience.
• Experience with advanced pharmacometric approaches, study design and reporting using modeling or simulation, or M&S contributions to regulatory interactions and submissions.

Pay

$188,100 to $313,500 USD annual base salary

Tools

NONMEM, Monolix, R