Career Category

Scientific

Job Description

Amgen is seeking a highly motivated and team-oriented candidate for the position of Senior Scientist in the Clinical Pharmacology, Modeling and Simulation (CPMS) department focusing on use of data science and predictive analytics methodologies to support drug development via pharmacometric and quantitative systems pharmacology modeling.

The Senior Scientist will be responsible for developing and executing an integrated predictive analytics strategy to complement the pharmacometric modeling to make robust inferences to support clinical drug development across diverse therapeutic areas.  The Senior Scientist will partner closely with other CPMS scientists across therapeutic areas as well as external vendors/partners to develop and support innovative data science based pharmacometric analyses and execute Modeling and Simulation (M&S) strategy to efficiently accelerate drug development by enabling quantitative decision making.  The Senior Scientist will work closely with other functions within Amgen, collaborating with other functional areas within experimental sciences (such as clinical pharmacology, digital health, pharmacokinetics and drug metabolism, and clinical biostatistics).  In addition, the Senior Scientist will assist in a wide range of activities such as working on complex datasets, recommending novel machine learning tools and statistical modeling of historical and preclinical data.

The typical role includes the development of machine learning tools, data visualizations, quantitative pharmacometric models, disease progression models, mechanistic and empirical PK/PD models, clinical trial simulations, literature meta-analysis using quantitative approaches and other state of the art techniques. The candidate is expected to be able to integrate modeling and simulation results into cross functional interactions, regulatory filings and their application to dose selection, study design, risk/benefit, and informing drug development decisions in close collaboration with other R&D partners.

Job Responsibilities may include

• Designs modeling and simulation and analytics components of clinical drug development plans and provides expertise to project teams including plan, design, execution and oversight of M&S plans for multiple programs in Amgen portfolio.
• Responsible for planning and execution of analyses to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs.
• Contributes to the analysis of in-vitro and pre-clinical PK/PD data for selection of first in humans (FIH) dose levels and contributes to IND submissions and documentation of appropriate reports.  
• Contribute to recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the clinical and Development teams and in regulatory documentation.
• Influences external environment through methods such as publication and presentations.
• Responsible for interfacing with partners (e.g. clinical pharmacologists, clinical assay group, statistics) to ensure appropriate support for programs and studies.
• Provide thought leadership, guidance and advice in own field, and develop innovative and creative output based on interpretation and analysis

Basic Qualifications

Doctorate degree and 2 years relevant experience

OR

Master’s degree and 5 years of relevant experience

OR

Bachelor’s degree and 7 years of relevant experience

Preferred Qualifications

• PhD in Statistical and Data sciences, Computer Science, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees (e.g. MD, PharmD)
• 3+ years of experience in the life sciences, Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
• Demonstrated experience with scripting and executing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R,  NONMEM, SAS, S-Plus, etc) is a plus
• Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is preferred
• Experience in PK/PD modeling and population-based analyses/simulations with established track-record of model-based drug development in multiple therapeutic areas will be an advantage
• Excellent interpersonal, technical, and communication skills to lead cross-functional teams
• Previous record of scientific contributions through peer-reviewed articles and external presentations

Amgen focuses on areas of high, unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.