AIRx, Sr. Director, Nonclinical Safety Lead
Core
Own the nonclinical safety strategy for the AIRx portfolio, designing safety packages and directing CRO execution to ensure AI-ready data for early drug discovery.
Role type
Senior IC nonclinical safety lead (toxicology)
Builds
Nonclinical safety dossiers and IND-enabling study packages for small molecule and biologics candidates
Domain
Biopharma drug discovery / Toxicology
Deliverable
production ML models
Required skills
Nonclinical safety strategy, CRO management, GLP study design, regulatory affairs (FDA/EMA/ICH), genetic toxicology, repeat-dose toxicology, safety pharmacology, in silico toxicity prediction, ADME-tox profiling, DMPK integration
Preferred skills
Board certification in toxicology, experience with AI-enabled data integration, early liability identification
Technologies
TetraScience, SAIL, in silico structural alert tools, in vitro hepatotoxicity/cardiotoxicity/genotoxicity assays
Responsibilities
Design and oversee in vitro and in vivo safety studies; integrate safety data into AI-enabled DMTA cycles; author nonclinical sections of INDs and regulatory briefing documents; lead early safety screening cascades; collaborate with DMPK on PK/TK and safety margins
Seniority
Senior, hands-on IC
