The Director of Toxicology will:
Plan and design all nonclinical studies, including non-GLP and GLP studies (safety pharmacology and toxicology studies), primarily through contract research organizations (CROs).
Manage the budget for non-clinical safety studies.
Manage contracts and coordinate activities with CROs; Serve as study monitor.
Prepare study reports and regulatory documents, including investigator’s brochures, INDs and NDAs.
Contribute to and participate in meetings and interactions with regulatory agencies.
Work closely with other functional areas such as Biology, Medicinal Chemistry, DMPK, CMC and Clinical.
Provide strategic preclinical expertise to cross-functional project teams as the in-house preclinical expert.
Ph.D. in toxicology, pharmacology, physiology, biology, or related discipline
10+ years of preclinical safety experience in the pharmaceutical/biotechnology industry experience
Diplomate, American Board of Toxicology (DABT)
Demonstrated expertise in nonclinical study design and management with small molecule drug candidates
Demonstrated track record of successful regulatory filings
Adequate understanding and experience in PK/TK studies
Experience in contracting and managing safety studies with reputable CROs
Experience with pre-IND through Phase 1-3 programs and associated regulatory filings
Experience in working with U.S. and European regulatory authorities