What are the responsibilities and job description for the Director, Nonclinical Safety position at Latigo Bio?
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
Salary : $230,000 - $260,000
