Director of Toxicology
Core
Provide scientific, strategic, and regulatory leadership for nonclinical safety activities across a portfolio of novel small molecule and antisense oligonucleotide (ASO) therapies for CNS disorders.
Role type
Director of Toxicology (Scientific Leadership)
Builds
Nonclinical safety strategies and IND-enabling development plans for CNS disorder therapies
Domain
Biopharmaceuticals / CNS Therapeutics / Nonclinical Safety (via careerplan.io/jobs/5394680008-director-of-toxicology-at-praxisprecisionmedicines)
Required skills
Toxicology strategy, GLP study oversight, regulatory toxicology (ICH/FDA/OECD), CRO management, risk assessment, team leadership, IND/NDA/MAA documentation
Preferred skills
DABT certification, reproductive/genetic toxicology, safety pharmacology, carcinogenicity, FDA reviewer experience
Technologies
GLP study protocols, IND/CTA/IB/DSUR/NDA/MAA documents
Responsibilities
Own nonclinical safety strategy for assigned programs; Design and oversee discovery, exploratory, investigative, and regulatory toxicology studies; Evaluate emerging safety findings and recommend paths forward; Lead regulatory toxicology activities and respond to health authority questions; Direct CROs and external partners; Partner across cross-functional teams to integrate safety into program strategy
Seniority
Director, hands-on scientific leadership with people management