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