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

Company Description: 

Latigo Biotherapeutics, Inc. is a private, early-stage biotechnology company focused on discovering and developing the next generation of non-opioid medicines for pain and pain-related syndromes. Our mission is the development of novel therapies that transform the lives of patients. The company is headquartered in Thousand Oaks, CA and has a highly successful management team as well as an experienced Board of Directors. At Latigo, we value science, patient-focus, and innovation.    

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.