
Privacy Policy
Job Openings
Associate Director, Toxicology
Serve as the nonclinical safety/toxicology subject matter expert on multidisciplinary project teams
Provide integrated assessments of nonclinical data and evaluate overall risk/benefit profiles
Design, oversee, and monitor nonclinical safety studies, including:
Exploratory/non-GLP toxicology studies
IND-enabling toxicology and safety pharmacology studies
Post-IND studies (e.g., sub-chronic, chronic, reproductive, carcinogenicity)
Analyze and interpret nonclinical study data to support program decisions
Prepare and present findings, and provide guidance to internal stakeholders and governance teams
Author and review nonclinical sections of regulatory documents, including:
INDs
Investigator’s Brochures (IBs)
Briefing books and responses to health authorities
Partner with Regulatory Affairs to support interactions with agencies (e.g., FDA)
Work closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams
Contribute to integrated development plans and timelines
PhD in Toxicology, Pharmacology, or related scientific discipline
DABT board certification is preferred
~10+ years of industry experience in nonclinical safety/toxicology
Experience supporting small molecule drug development programs preferred
Strong scientific judgment and problem-solving capabilities
Excellent communication and presentation skills
Ability to work effectively in cross-functional, fast-paced environments
Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations
Experience designing, monitoring, and interpreting nonclinical safety studies
Experience supporting regulatory submissions and agency interactions
Background in pain, neuroscience, or related therapeutic areas
Prior experience in early-stage biotech environments
Apply for This Job
Privacy Policy
•
Terms of Service
© BambooHR All rights reserved.
Originally posted by Latigo Biotherapeutics. View original posting
BioCareerAI is an independent job platform and is not affiliated with or endorsed by Latigo Biotherapeutics.
