Associate Director, Toxicology
Core
Lead nonclinical safety programs for a clinical-stage biopharmaceutical company's pipeline of alpha-helical peptides (Helicons™) from lead optimization through IND filing.
Role type
Associate Director, Toxicology (Scientific Leadership)
Builds
IND-enabling nonclinical safety packages for injectable therapeutic peptides and small molecules
Domain
Biopharmaceuticals / Drug Discovery / Toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
nonclinical safety program leadership, toxicology risk assessment, CRO management, GLP compliance, regulatory document authoring, injectable formulation safety, IND-enabling study design, scientific strategy definition
Preferred skills
DABT certification, New Approach Methodologies (NAMs), organoid/microphysiological systems, in silico predictive models, regulatory agency meeting support, in-licensing due diligence
Technologies
GLP regulations, ICH guidelines (M3(R2), S6(R1), S7A/B, S8, S9), 21 CFR Part 58, microphysiological systems, iPSC-derived models, QSAR platforms
Responsibilities
Define and execute nonclinical safety strategies for candidates from lead optimization to IND filing; manage CROs and specialty labs for GLP/non-GLP studies; author nonclinical sections of INDs and CTAs; mentor junior scientists; champion innovation in safety tools to reduce animal use; oversee test article logistics and stability; interpret interim data and make real-time scientific decisions.
Seniority
Senior, hands-on scientific leader