Toxicology Director

Job Summary

To support drug development initiatives, the full-time salaried Toxicology Director will manage non-clinical and clinical development plans, oversee toxicology studies, and collaborate with cross-functional teams while working remotely.

Key responsibilities

• Contribute to due diligence and gap analysis of nonclinical data packages
• Design programs to support INDs, NDA/BLAs, and post-registration studies
• Serve on cross-functional drug development teams as the toxicology lead

Required qualifications

• PhD in Pharmacology or Toxicology, or related field with 4-6 years of relevant experience
• Experience in the design and outsourcing of GLP and non-GLP toxicology studies
• Familiarity with addressing regulatory agency inquiries regarding nonclinical studies
• Experience authoring nonclinical sections of INDs and NDA/BLA submissions
• Drug development experience across multiple therapeutic areas such as oncology or CNS