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 Principal Scientist, Clinical Pharmacology for
its San Francisco, CA location. This position reports to Director,
Clinical Pharmacology Hematology Oncology Therapeutic Area
The Principal Scientist of Clinical Pharmacology will be
responsible for the development and implementation of the Clinical
Pharmacology and Pharmacometric strategies for cutting-edge novel
modalities including Bi-specific T-cell engagers, Bi-specific
antibodies, oncolytic viruses, antibody-drug-conjugates, CAR-T
cells based immunotherapies in addition to small molecule &
mono-clonal antibodies. The Principal Scientist will be a Subject
Matter Expert of clinical pharmacology who will apply Model-Based
Drug Development and principles of quantitative clinical
pharmacology to ensure optimal drug development and will represent
the Clinical Pharmacology, Modeling & Simulation Department at the
global drug development teams.
- Doctorate degree and 3 years of Pharmaceutical or Biotech
- Master's degree and 5 years of Pharmaceutical or Biotech
- Bachelor's degree and 7 years of Pharmaceutical or Biotech
- PhD (in Pharmacokinetics or Pharmaceutics or Pharmaceutical
Sciences or equivalent professional degrees e.g. MD, PharmD).
- 5+ years of experience in Clinical Pharmacology and
Pharmacometrics in the Biotechnology/Pharmaceutical Industry.
- Established track-record of experience in designing strategic
integrated clinical pharmacology & modeling & simulation plans in
support of development of small molecule and therapeutic
- Hands-on experience in quantitative clinical pharmacology
approaches including Population Pharmacokinetics and Population
Pharmacokinetic/Pharmacodynamic modeling and simulation and
Physiologically Based Pharmacokinetic modeling and simulation.
- Experience in leading the design and execution of clinical
pharmacology and biopharmaceutic studies including bioequivalence,
bio-comparability, 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.
- Established track-record of interaction with global health
authorities, authoring regulatory documents, knowledge of global
regulatory requirements and guidance.
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
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.