Job Description

Biotechnology opened the door to new types of medicines based on natures own building blocks. No company has done more to advance this revolution than Amgen & the companys 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
Masters degree and 5 years of Pharmaceutical or Biotech industry experience
OR
Bachelors 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.