VP, DMPK & Toxicology

  • Location: San Diego, California
  • Type: Direct Hire
  • Job #17616

VP, DMPK & Toxicology
Location: San Diego Area
Our clinical stage client is changing the landscape in RNA medicines.  With a robust pipeline and programs from Discovery to Preclinical, this group is going to offer life-changing treatment options to many patients for the first time ever!

Essential Duties and Responsibilities:
 

  • Key member of internal drug development team representing the DMPK and toxicology functions
  • Lead the initiation, development, and execution of drug metabolism and pharmacokinetic (DMPK) studies and PK/PD in rodents and non-human primates (NHPs) to support IND etc
  • Oversee the design of ELISA and mass-spectrometry based assays to support bioanalysis and pharmacokinetic modeling in non-clinical and clinical settings
  • Design, implement and oversee internal and external non-GLP and GLP in vitro, in vivo and ex vivo safety studies internally and at CROs to support IND and related regulatory filings
  • Interpret pharmacokinetic, safety pharmacology and toxicity studies with support from internal and external team members
  • Manage a group of scientists and external consultants representing DMPK, toxicology and non-clinical operations 
  • Author nonclinical sections of INDs and other regulatory filings related to PK, bioanalysis, and toxicology

Requirements:
 

  • PhD in pharmacokinetics, bioanalysis, pathology, toxicology, or a related discipline
  • 7-10+ years of experience at a biotechnology or pharmaceutical company in DMPK and toxicology
  • Proven track record developing DMPK and toxicology strategies to support IND and related regulatory filings.
  • Familiarity with GLP regulations and health agency guidance and strategies to support global drug development of oligonucleotide therapeutics
  • Experience in interacting with the US and/or international regulatory agencies
  • Experience with oligonucleotides and/or neurology

For immediate consideration, email ava@scientificsearch.com and mention Job#17616