Sr. Scientist, Clinical Pharmacology

South San Francisco, CA, US
Jan 21, 2021
Required Education
Bachelors Degree
Position Type
Full time
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 .

The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Senior Scientist-Clinical Pharmacology for its San Francisco, CA location. This position reports to Director of Clinical Pharmacology, Modeling & Simulation.

The Senior 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 Senior Scientist will be Subject Matter Expert who will apply cutting-edge Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches including Physiologically Based Pharmacokinetic (PBPK) modeling, Mechanistic PK/PD modeling and Quantitative Systems Pharmacology (QSP) modeling to ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal drug development.

Basic Qualifications:

Doctorate degree and 2 years of Pharmaceutical or Biotech industry experience
Master's degree and 5 years of Pharmaceutical or Biotech industry experience
Bachelor's degree and 7 years of Pharmaceutical or Biotech industry experience

Preferred Qualifications:
  • PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).
  • 3 to 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
  • Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies. Expert knowledge of commonly used software for PBPK modeling required.
  • Experience with development of PK and PK/PD strategies, PK/PD data analysis, interpretation, and reporting of PK and PK/PD data from clinical studies. 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 would be a plus.
  • Established track record of Model Based Drug Development.
  • Established track record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.

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.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.