Hurley Consulting Associates Ltd. is seeking a Toxicologist to join our Scientific Affairs group. PhD or DVM with a minimum of 5 to 10 years’ pharmaceutical industry experience. Diplomate of the American Board of Toxicology (DABT) is preferred. The successful candidate must have excellent written and oral communication skills and have a working knowledge of US and global regulatory and compliance requirements (FDA, CFR, ICH, and OECD). The main focus of this position is to support the safety assessment of small molecules and biologics in various stages of development.
The responsibilities include:
Contribute to the preparation of regulatory submissions including INDs, NDAs, and BLAs which includes preparation of written and tabular toxicology summaries
Participate in cross-functional teams as a toxicology/safety expert and provide support to others in the preparation, analysis, and documentation of studies
Provide expert opinion on nonclinical toxicology, toxicokinetic, and safety studies planned or performed
Contribute to the design, monitoring, and reporting of GLP and non-GLP toxicology, toxicokinetic, and safety studies performed by clients or at CROs in compliance with US and global regulatory requirements
Interact with clients and regulatory authorities when needed to address toxicology/safety related matters
Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance, and a 401(k) plan.