Amgen is seeking a Scientist to join the Pharmacokinetics & Drug Metabolism (PKDM) department at our Kendall Square site in Cambridge, Massachusetts.
In this role, you will add to the discovery and non-clinical development of small molecule therapeutics using physiologically based pharmacokinetic modeling (PBPK). You will be responsible for establishing and implementing PKDM strategy to achieve project team goals integrating PBPK simulations with other aspects of drug discovery including disease biology, chemistry/protein sciences, toxicology and clinical pharmacology to advance the best therapeutic candidates. In addition, you will make meaningful and innovative contributions to the fundamental understanding of the factors that affect the absorption, distribution, and clearance of small molecule therapeutics.
In this position, your core responsibilities are to:
Serve as a functional representative and subject matter expert on PBPK modeling of small molecule therapeutics and collaborate with scientists across our three-site PKDM scientific community (Cambridge, MA, San Francisco and Thousand Oaks, CA)
Evaluate, implement and develop in vitro and in silico tools to support the prediction of pharmacokinetics (PK) and drug interactions (DDIs) in humans
Articulate risk and mitigation strategies for human PK predictions, clinical dose projections and DDI study design
Design and complete IND and NDA-enabling PBPK simulations to support regulatory submissions
You will also have opportunities to learn and obtain experience with PKDM strategies for the discovery and non-clinical development of protein therapeutics.
In addition to the core responsibilities, the position provides the opportunity to pursue scientific inquiries into the fundamental physiological and biochemical factors that determine the absorption, distribution, and clearance of small molecule and protein therapeutics. A collaborative and highly capable scientific community at Amgen is available to support these efforts. Interactions and collaboration with academic and other external scientists is encouraged.
Master's degree and 4 years of scientific experience
Bachelor's degree and 6 years of scientific experience
A Ph.D. in pharmaceutical, chemical, or biological science
2+ years of drug discovery and/or development experience
Expertise using PBPK platforms (e.g. Simcyp, GastroPlus, Phoenix WinNonlin, or Matlab)
Knowledge of PK, PD and/or distribution of small molecule therapeutics
Critical thinking, and demonstrated ability to communicate with team members across broad disciplines
Effective oral and written communication skills
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
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.