Director, Toxicology

Responsibilities

• Contribute to due diligence and gap analysis of nonclinical data packages
• Design programs to support INDs, NDA/BLAs and post-registration studies
• Outline studies and in partnership with clients, identify CROs to run these studies; manage the data/information analysis with our client to draft reports and finalize with client
• Prepare content of regulatory documents for filing
• Design investigative programs to address toxicology findings/issues/circumstances to determine human relevance
• Represent client to regulatory authorities (as needed/requested)
• Aid client response to any regulatory inquiries to nonclinical studies
• Serve on cross-functional drug development teams as toxicology lead
• May manage a limited number of direct reports

Qualifications

• PhD in Pharmacology or Toxicology, or related field with a minimum of 4-6 years of post-degree experience in a drug development company, consulting organization, CRO, or FDA
• Pertinent Board Certification desirable
• Experience in the design and outsourcing of GLP and non-GLP toxicology and safety pharmacology studies
• Experience in addressing comments/questions from Global regulatory agencies is expected
• Drug development experience across multiple therapeutic areas, such as oncology, CNS, inflammation, metabolic disease, or cardiovascular
• Experience authoring the relevant nonclinical sections of IND’s and NDA/BLA’s