Amgen Principal Scientist - Clinical Pharmacology in Thousand Oaks, California
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 Principal Scientist-Clinical Pharmacology for its Thousand Oak, CA location. This position reports to Director of Clinical Pharmacology & Modeling Simulation.
The Principal 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 Principal Scientist will be a member of cross-functional global drug development teams as the Clinical Pharmacology & Modeling, Simulation department representative & will be 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 & 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 industry experience
Master's degree and 6 years of Pharmaceutical or Biotech industry experience
Bachelor's degree and 8 years of Pharmaceutical or Biotech industry experience
PhD (in Pharmacokinetics or Pharmaceutical Sciences or equivalent professional degrees (e.g. MD, PharmD).
7+ years of experience as Clinical Pharmacologist in product development.
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.
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.
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.