Our well-funded Cambridge start-up client is seeking an experienced Toxicologist to lead pipeline projects by directing GLP & non-GLP studies with CROs and participating in Regulatory filings. You will work closely with program leaders, clinical and regulatory teams to develop an overall toxicology development plan including lead optimization, candidate selection, IND-enabling studies, etc.
Responsibilities include but are not limited to;
• Interact with CROs for quotes, cost estimates, and monitor study activities including protocol development and report generation.
• Provide strategic advice to senior leadership and relevant project teams regarding potential impact of study results on program and clinical/regulatory strategy.
• Communicating with regulatory bodies in support of global regulatory submissions.
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a Ph.D. in Toxicology or relevant field with a minimum of 3 – 5+ years of experience in nonclinical development and conducting regulatory toxicology studies. More experienced candidates can also be considered. Candidates who have DABT certification are welcome but it is not required to be considered. Candidates must have experience in various aspects of toxicology study conduct including developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology as well as experience in designing, conducting, monitoring, and interpreting discovery and exploratory toxicology studies to assist lead optimization and candidate selection efforts. Must also have experience in management of external CROs and representing Toxicology function to global regulatory agencies in support of submissions.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.