Career Category

Clinical

Job Description

Job Description

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 https://www.amgenscience.com/features/the-shape-of-drugs-to-come/

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 Leader. 

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.

Basic Qualifications:

• Doctorate degree and 3 years of Pharmaceutical or Biotech industry experience

OR

• Master’s degree and 5 years of Pharmaceutical or Biotech industry experience

OR

• Bachelor’s degree and 7 years of Pharmaceutical or Biotech industry experience

Preferred Qualifications:

• 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 proteins.
• 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.
  #GDO2021

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