We're looking for an experienced Toxicologist to join a clinical stage biopharmaceutical company with a worldwide reputation in the field of neurodegenerative diseases.
In this role, you will be responsible for the design and oversight of preclinical safety assessments for all products and will report to the VP of Translational Medicine and Regulatory Affairs. You will lead and manage toxicology programs; communicating toxicology plans, results, and reports to the FDA and other regulatory authorities as needed.
To be successful in this role, you should have considerable prior experience managing safety assessment studies. A strong background in toxicology including extensive knowledge and understanding of ICH requirements and Good Laboratory Practices is required.
Responsibilities:
Design and oversee the conduct, interpretation, and reporting of regulatory 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 consulting toxicologists, and affiliated nonclinical and clinical development functions as necessary
Coordinate toxicological/nonclinical safety evaluations of development candidates locally and internationally with CROs and consultants
Aid in authorship of pertinent sections of internal and external regulatory documents (IBs, IND sections, briefing documents etc.)
Coordinate resolution of toxicological issues arising in drug development programs, to allow adequate assessment of the relevance of any toxicological findings to human safety.
Collaborate on design of investigative toxicity studies in support of development compounds as needed
Education:
MS, Ph.D. in Toxicology or DVM with relevant toxicology experience
DABT Board certification a plus
Experience: