Sr Scientist-Clinical Pharmacology-Modeling & Simulation
Amgen Clinical Pharmacology Modeling and Simulation (CPMS) is seeking a Senior Scientist who will serve as a Pharmacokinetics/Pharmacodynamic (PK/PD) modeler (ie, pharmacometrican) to support Amgen Development and Translational Sciences programs across multiple therapeutic areas of oncology/hematology, cardiovascular disease, inflammation, bone health, nephrology and neuroscience.
Key responsibilities of the Senior Scientist include:
- Responsible for creation and execution of Modeling and Simulation (M&S) plans that include conducting
- PK/PD analyses for small and large molecules from early to late drug development phase using pharmacostatistical modeling techniques
- mechanistic modeling for translational biomarkers
- meta-analysis using literature data
- clinical trial simulations to support dose selection, study design, and drug development decisions
- Lead author for PK/PD reports and contribute to the summary documents for regulatory submissions.
Participate in cross-functional project teams and provide scientific input.
Contribute to clinical pharmacology plan by establishing high impact M&S strategy for the program(s)
Responsible for responses to questions from regulatory reviews.
Doctorate degree and 2 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
Master's degree and 5 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
Bachelor's degree and 7 years of Pharmacokinetics/Pharmacodynamic or statistical modeling experience
- PhD in applied (bio)statistics, applied biomathematics/biophysics, (bio)engineering or related fields with equivalent professional degrees (e.g. MD, PharmD) with 3 years of PK/PD or statistical modeling experience
- Experience in analyzing PK/PD and/or clinical trial data using advanced pharmacometric or statistical modeling methodologies
- Experience in conducting clinical trial simulations to assist study designs
- Proficiency in modeling software (e.g. NONMEM, SAS, R/S-Plus, STAN, MATLAB)
- Excellent interpersonal, technical, and communication skills
- Previous record of scientific contributions through peer-reviewed articles and external presentations