AIRx, Sr. Director, Nonclinical Safety Lead
$212,000–$333,190 year
HybridBoston, Massachusetts, United States
Job Summary
Takeda AIRx Nonclinical Safety Lead: Own the nonclinical safety strategy across AIRx portfolio, from early screening through IND-enabling, designing disease- and hypothesis-driven safety packages; direct CRO execution and integrate safety data with AI-enabled DMTA cycles; lead early safety screening design (in silico toxicity, off-target liability, genotoxicity, reactive metabolite assessment) and oversee repeat-dose, genetic toxicology, and safety pharmacology studies; author and review nonclinical sections of INDs/CTAs and regulatory briefing materials; collaborate with DMPK to align PK/TK/metabolite profiling with safety decisions; stay current with ICH, FDA, EMA guidelines and ensure safety data are AI-ready for downstream model training; contribute to Takeda’s AI-enabled discovery model and cross-functional program delivery; role is based in Cambridge, MA with a hybrid work arrangement and regulatory-focused responsibilities across small molecules and biologics.
Required Qualifications
- PhD in toxicology, pharmacology, biochemistry, or closely related discipline
- board certification or fellowship in toxicology (DABT, ERT, or equivalent) strongly preferred
- 12–15+ years of pharmaceutical drug discovery experience with a strong hands-on track record in nonclinical safety strategy and IND-enabling toxicology for small molecule and biologics projects
- expert knowledge of ICH guidelines, FDA and EMA non-clinical expectations, and the regulatory context governing non-clinical safety for first-in-human studies
- deep expertise in genetic toxicology, repeat-dose toxicology, safety pharmacology (core battery and supplemental), immunotoxicology
- proficiency in early safety screening: in silico structural alert tools, in vitro hepatotoxicity, cardiotoxicity and genotoxicity assays, off-target liability and reactive metabolite assessment, immunogenicity assessment and ADME/tox profiling
- track record designing, directing, and critically interpreting externalized CRO GLP and non-GLP safety study packages
- ability to succinctly summarize nonclinical content for regulatory submissions (IBs and clinical protocols)
- experience at the DMPK/toxicology interface: TK analysis, metabolite profiling, safety margin assessment, and species rationale
- AI/ML data literacy; comfortable working with multi-source safety datasets and integrating in silico predictions with experimental outputs
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