7 months ago
My client, a Clinical stage biotech, is looking for a Toxicology Director to be responsible for the management of the Regulatory Toxicology Group and they will have oversight of all regulated safety programs in addition to the expectation of serving at the individual project team level to support progression of novel therapeutic agents through the drug development process. A strong background in Regulatory Toxicology including extensive knowledge and understanding of Good Laboratory Practices (GLPs), ICH Guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences and Dossiers is required.
- Management and oversight of regulatory Toxicology teams
- Oversight of design, conduct, interpretation, and reporting of early and late stage toxicity studies
- Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery toxicologists, and affiliated preclinical and clinical development functions, as necessary
- Coordinate preclinical safety evaluations locally and internationally with CROs and other external parters
- Responsible for relevant regulatory documents (IBs, BLAs, INDs, NDAs, Expert Reports, etc.)
- Ph.D. in Toxicology or relevant field; DABT Board certification preferred.
- A minimum of 10 years of experience in industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage personnel and multiple scientific projects, and make sound scientific interpretations and risk assessments
- Proficient knowledge of general toxicology is required
- Highly proficient in understanding and knowledge of regulatory toxicology
- Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities