Senior Scientist – Pharmacology and Toxicology

Location
Fremont, California
Posted
Dec 22, 2017
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Senior Scientist – Pharmacology and Toxicology
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are seeking a scientist who enjoys working on hard-to-treat diseases. This is an opportunity to characterize the pharmacokinetics, pharmacodynamics, and toxicology of an expansive number of novel candidates across several therapeutic areas. You will have a range of responsibilities, from working with our in vivo pharmacology and toxicology group to providing input on nonclinical pharmacology, as well as pharmacokinetic programs, protocols, reports, and regulatory content.

Responsibilities:

  • Design and implement in vivo PK/ADME assays for compound profiling
  • Develop and manage DMPK and bioanalysis studies in-house and at CROs
  • Design and execute key PK and biodistribution studies to support compound progression from lead optimization to clinical candidate selection
  • Conceptualize and develop toxicology study designs (GLP and non-GLP)
  • Interface with and manage CROs

Qualifications:

  • DVM or PhD. In Pharmacology/Toxicology or Biological Sciences
  • 10-15 years of industry experience in conducting biologics and pharmaceutical R&D
  • Experience in managing CROs
  • Working knowledge of FDA, EMA, and ICH guidance documents including GLP and GMP regulations
  • Experience in authoring regulatory submissions
  • Demonstrated experience in evaluating PK/PD correlations, PK modeling, and parameter estimation preferred