Amgen

Principal Scientist - Clinical Pharmacology, Modeling & Simulation

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Feb 12, 2019
Ref
R-57317
Required Education
Doctorate/PHD/MD
Position Type
Full time
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.

Basic Qualifications:

Doctorate degree and 3 years of Pharmaceutical or Biotech experience
OR
Master's degree and 6 years of Pharmaceutical or Biotech experience
OR

Bachelor's degree and 8 years of Pharmaceutical or Biotech experience

Preferred Qualifications:
  • 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.


Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.

.