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.
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
MS, Ph.D. in Toxicology or DVM with relevant toxicology experience
DABT Board certification a plus
5 plus years of experience in the pharmaceutical/biotech industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage multiple scientific projects, make sound scientific interpretations and provide risk assessments
Proficient knowledge of general toxicology
Experience with Pharmacokinetic (PK) analysis is a plus
Working knowledge of US and ICH regulatory toxicology requirements
Experience with design and execution of GLP toxicology studies required for safety assessment of biologics including PK and ADA assessment
Experience with GLP toxicology study design required for safety assessment of small molecules a plus
Strong interpersonal skills with an ability to develop solid working relationships and to work effectively in a team setting/matrix-type organization
Oral and written communication capabilities sufficient for successful management of CROs and regulatory writing