AIRx, Sr. Director, Nonclinical Safety Lead

Takeda•Boston, MA

2d•$212,000 - $333,190•Hybrid

About The Position

Takeda Research is constructing a Lab of Tomorrow built on AI, automation, new ways of working, and talent with the singular vision of delivering differentiated medicines to the clinic at speed and cost. To catalyze these efforts, Takeda is creating two complementary units: AI Research Accelerator (AIRx) and Discovery Automation & Robotics (DAR). AIRx will have a group of a dedicated group of experienced biologic drug hunters with the autonomy of a biotech and the resources of a leading pharmaceutical company. It is designed to incubate the future AI-powered operating models for large molecule discovery and deliver candidates to the clinic at industry leading speed and success rates. Purpose In AIRx, every go/no-go decision carries real cost, and the safety call is the one that stops a program or sends it forward. As Nonclinical Safety Lead, you own the safety strategy that supports every candidate in the AIRx portfolio: designing the nonclinical safety package, directing CRO execution with precision, and ensuring that the data generated at CROs is interpretable, AI-ready, and decisive. It is a scientific strategy role combined with a hands-on project toxicologist function in a unit that moves at biotech speed. You will be embedded in the DMTA cycle from early hit assessment through IND-enabling studies, working alongside medicinal chemists, computational scientists, and biologists to flag liabilities early, design around them fast, and build the nonclinical dossier that gives programs the best possible chance in the clinic. The right person for this role is a seasoned nonclinical safety expert who is as comfortable directing and critically interpreting study packages as they are challenging a SAR hypothesis on the basis of a structural alert; and who sees AI-enabled data integration not as a future concept but as how they want to work today.

Requirements

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
Strong ability to work and make safety-related decisions independently; readiness to seek external expert advice when necessary
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; working knowledge of phototoxicity, reproductive and developmental toxicology
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 and effectively summarize the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocols
Experience working at the DMPK/toxicology interface: TK analysis, metabolite profiling, safety margin assessment, and species selection rationale
AI/ML data literacy; comfortable working with large multi-source safety datasets and integrating in silico predictions with experimental outputs in a DMTA context
Deep experience in at least one of Takeda's priority therapeutic areas (oncology, neuroscience, gastroenterology/immune/inflammation)
Excellent cross-functional collaboration and scientific communication skills; able to translate complex toxicology findings into clear program implications for non-specialist audiences and governance forums

Responsibilities

Own the nonclinical safety strategy across the AIRx portfolio, including small molecule and biologics projects, from early screening through IND-enabling studies; ensure every program has a clear, risk-proportionate toxicology plan aligned to its clinical hypothesis and regulatory pathway
Design and oversee CRO- or in-house executed in vitro and in vivo safety studies; write and review study protocols, critically interpret data packages, and determine their implications for program progression
Integrate safety data into AI-enabled DMTA cycles; partner with Medicinal and Computational Chemists to flag structural liabilities early, interpret ADME-tox outputs, and feed clean, standardized safety data into AIRx data systems (TetraScience, SAIL) for AI/ML use
Lead early safety screening cascade design including: in silico toxicity prediction, off-target liability assessment, geno- and organ-toxicity screening, and reactive metabolite assessment — to inform design decisions before significant synthesis investment
Oversee repeat-dose, genetic toxicology, safety pharmacology studies as programs progress; ensure GLP studies are scoped correctly and delivered on time and to quality
Author and review nonclinical sections of INDs, CTAs, and key regulatory briefing documents; serve as Takeda's scientific representative in regulatory interactions concerning non-clinical safety
Collaborate closely with DMPK to integrate PK/TK, metabolite profiling, and safety margin calculations into program decision frameworks; ensure PK-PD-toxicity relationships are clearly articulated and expressed in safety margins to clinically meaningful doses
Stay current with evolving regulatory guidance (FDA, EMA, ICH) on nonclinical safety requirements; proactively assess and communicate implications for AIRx program timelines and study designs
Contribute to the scientific rigor and AI-readiness of AIRx safety data — ensuring assay outputs are standardized, annotated, and structured for downstream model training and insights generation
Shape how nonclinical safety is practiced in the AIRx model — your approach to early liability identification and CRO direction will become part of the template Takeda Research scales across its future AI-enabled operating model