Director / Senior Director, Toxicology
Core
Lead nonclinical safety strategy for ultra-long-acting hydrogel-based conjugate therapeutics, integrating toxicology with DMPK, pharmacology, and clinical development from lead selection through IND.
Role type
Senior Director, Toxicology
Builds
Nonclinical safety data packages and regulatory submissions for preclinical and early clinical development
Domain
Biotechnology / Preclinical Toxicology
Required skills
GLP study design and oversight, CRO network management, regulatory document authoring, safety margin assessment, cross-functional leadership, IND/IMPD filing expertise
Preferred skills
Experience with hydrogel-based platforms, peptide payload safety, combination toxicology strategies
Technologies
GLP standards, SEND-compliant datasets, regulatory submission formats
Responsibilities
Define stage-specific safety data needs and go/no-go recommendations; Design and oversee GLP/non-GLP toxicology studies; Manage global CRO selection, qualification, and audit; Author nonclinical sections of regulatory submissions; Lead project teams for preclinical programs; Assess immunogenicity and hypersensitivity risks
Seniority
Senior Director, strategic leadership & hands-on execution