AIRx, Sr. Director, Nonclinical Safety Lead

Role: Nonclinical Safety Lead within Takeda's AI-driven AIRx unit, overseeing safety strategies for early-stage drug discovery programs, including small molecules and biologics. Responsibilities: design and direct nonclinical safety packages, manage CRO studies, interpret complex safety data, and ensure AI-readiness of all safety outputs; collaborate with medicinal chemists, computational scientists, and regulatory teams from hit identification through IND-enabling studies. Requirements: PhD in toxicology, pharmacology, or related field; 12+ years in pharmaceutical nonclinical safety, with expertise in toxicology, safety pharmacology, genotoxicity, and regulatory standards (FDA, EMA, ICH); proficiency in in silico toxicity tools, ADME/TK profiling, and AI/ML data integration; experience with IND/CTA submissions and regulatory interactions. Preferred: board certification (DABT, ERT), deep experience in oncology, neuroscience, or immunology. High-Value: focus on AI-enabled safety data integration, early liability assessment, and cross-disciplinary collaboration to accelerate drug candidate progression. Location: Cambridge, MA, with hybrid work arrangement. The role emphasizes leadership, decisive judgment, innovation in safety assessment, and external stakeholder engagement, supporting Takeda’s vision to deliver differentiated medicines rapidly and efficiently.