Scientist - Clinical Pharmacology Modeling and Simulation
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.
- Doctorate degree
- Master's degree and 4 years of Biotechnology/Pharmaceutical Industry experience
- Bachelor's degree and 6 years of Biotechnology/Pharmaceutical Industry experience
- 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.