Amgen Principal Scientist - Clinical Pharmacology, Modeling & Simulation in Thousand Oaks, California
Amgen is seeking a Principal Scientist to work out of our Thousand Oaks locations. This position will report to Director Medical Sciences.
The Principal Scientist will be a member of cross-functional global drug development teams as the Clinical Pharmacology, Modeling & Simulation department representative. They will act as the Subject Matter Expert who will apply cutting-edge Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches to ensure development of safe & effective dosing regimens for various patient sub-populations and also ensure optimal drug development. The Principal Scientist will also be responsible for designing integrated Clinical Pharmacology Modeling & Simulation plans & designing, planning and execution of clinical pharmacology studies in support of these plans.
Doctorate degree and 3 years of Pharmaceutical or Biotech experience
Master's degree and 6 years of Pharmaceutical or Biotech experience
Bachelor's degree and 8 years of Pharmaceutical or Biotech experience
PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology) or (MD or PharmD)
8+ years of experience as Clinical Pharmacology Modeling & Simulation functional representative on product development teams in the Biotechnology/Pharmaceutical Industry.
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, Adsorbtion, Distribution, Metabolization, and Excretion (ADME) and pediatric studies and integrating results into regulatory filings, and product labels.
Established track record of Model Based Drug Development. Hands-on experience in population PK/PD & PBPK modeling and simulation.
Experience with PK and PK/PD strategies, data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies.
Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance's.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.