Scientist - Clinical Pharmacology Modeling and Simulation

Employer
Amgen
Location
Thousand Oaks, California
Posted
Oct 11, 2018
Ref
R-64273
Required Education
Doctorate/PHD/MD
Position Type
Full time

Amgen, Thousand Oaks, CA is seeking a highly motivated and team-oriented candidate for the position of Scientist in the Clinical Pharmacology Modeling & Simulation Department within Medical Sciences. The individual will be responsible for the designing, planning and execution of clinical pharmacology strategies & studies in support of development of small and large molecule drugs & cutting-edge novel modalities.

Basic Qualifications

  • Doctorate degree

OR

  • Master's degree and 4 years of Biotechnology/Pharmaceutical Industry experience

OR

  • Bachelor's degree and 6 years of Biotechnology/Pharmaceutical Industry experience

Preferred Qualifications

  • PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or equivalent professional degree (MD or PharmD)
  • 3 years of experience as Clinical Pharmacology functional representative on product development teams in the Biotechnology/Pharmaceutical Industry.
  • Experience in designing strategic 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.
  • Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
  • Hands-on experience in population PK/PD & PBPK modeling and simulation.
  • Experience in authoring regulatory documents, knowledge of global regulatory requirements and guidances, and experience of interaction with global health authorities.