Director, Nonclinical Safety

Position Description

Reporting to the VP of Translational Science, the Director of Nonclinical Safety will work in our early development teams with a responsibility for designing and executing on the nonclinical safety strategy for small molecule programs, connecting the project from discovery into IND-enabling and FIH studies. As the nonclinical safety subject matter expert (SME), you will be responsible for nonclinical toxicology studies in support of IND submissions.

Primary Responsibilities

• Serve as nonclinical safety subject matter expert on project teams from discovery into early development.
• Design and execute nonclinical safety strategies and provide development plans.
• Analyze, interpret and summarize cGMP safety data to internal teams.
• Provide risk assessment and implement de-risking strategies in discovery teams to support candidate selection.
• Author regulatory documents including Investigator Brochures, IND’s, IND updates, and interact with regulatory agencies (US and ex-US) as needed.
• You will be responsible for oversight and interaction with consultants and vendors assigned to support nonclinical safety.
  
  

Qualifications And Requirements

• PhD or DMV in toxicology, pharmacology, or related discipline.
• 12 years of experience in nonclinical safety supporting early development in a biotech or pharmaceutical organization.
• Prior nonclinical safety experience with small molecules is required.
• Experience in therapeutic areas related to pain management preferred.
• Experience with regulatory submissions in early development is required.
  
  

Location:

This position can be located in Thousand Oaks, CA or the San Francisco Bay Area