Senior Scientist - Clinical Pharmacology

Biotechnology opened the door to new types of medicines based on nature's own building blocks. No company has done more to advance this revolution than Amgen & the company's broad toolkit of drug modalities just got larger www.amgenscience.com/the-shape-of-drugs-to-come .

The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Senior Scientist-Clinical Pharmacology for its San Francisco, CA location. This position reports to Director of Clinical Pharmacology, Modeling & Simulation .

The Senior Scientist of Clinical Pharmacology will be responsible for the development and implementation of the Clinical Pharmacology and Modeling Simulation strategies for cutting-edge novel modalities including Bi-specific T-cell engagers, antibody-drug-conjugates, CAR-T cells, oncolytic viruses based immunotherapies in addition to small molecule & mono-clonal antibodies. The Senior Scientist will be Subject Matter Expert who will apply cutting-edge Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches including Physiologically Based Pharmacokinetic (PBPK) modeling, Mechanistic PK/PD modeling and Quantitative Systems Pharmacology (QSP) modeling to ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal drug development.

Basic Qualifications:

Doctorate degree and 2 years of Pharmaceutical or Biotech industry experience
OR
Master's degree and 5 years of Pharmaceutical or Biotech industry experience
OR
Bachelor's degree and 7 years of Pharmaceutical or Biotech industry experience

Preferred Qualifications:
  • PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).
  • 3 to 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
  • Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PBPK modeling required.
  • Experience with development of PK and PK/PD strategies, PK/PD data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.Experience in designing strategic integrated clinical pharmacology & modeling simulation plans in support of development of small molecule and/or protein therapeutics.
  • Experience in leading the design and execution of clinical pharmacology studies including bioequivalence, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels would be a plus.
  • Established track record of Model Based Drug Development.
  • Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.


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If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

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