AIRx, Sr. Director, Nonclinical Safety Lead
Core
Own the nonclinical safety strategy for AI-powered biologic drug discovery, designing safety packages and directing CRO execution to ensure data is AI-ready for IND-enabling studies.
Role type
Senior Director, Nonclinical Safety Lead
Builds
Nonclinical safety dossiers and AI-integrated toxicology data pipelines for small molecule and biologic candidates
Domain
Biopharmaceutical drug discovery (large molecules) and AI-enabled toxicology
Deliverable
production ML models | product features
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, AI/ML data literacy
Preferred skills
Board certification in toxicology, experience in oncology/neuroscience/gastroenterology, structural alert interpretation
Technologies
TetraScience, SAIL, in silico structural alert tools, in vitro hepatotoxicity/cardiotoxicity/genotoxicity assays
Responsibilities
Design nonclinical safety packages and oversee CRO execution; integrate safety data into AI-enabled DMTA cycles; lead early safety screening cascades; author nonclinical sections of INDs and regulatory documents; collaborate with DMPK on PK/TK and safety margins; stay current with evolving regulatory guidance
Seniority
Senior Director, strategic leadership with hands-on scientific execution