AIRx, Sr. Director, Nonclinical Safety Lead

Takeda•Boston, MA

11h•Hybrid

About The Position

Takeda Research is building a Lab of Tomorrow focused on AI, automation, and new working methods to deliver differentiated medicines efficiently. To support this, Takeda is establishing two units: AI Research Accelerator (AIRx) and Discovery Automation & Robotics (DAR). AIRx will consist of experienced drug hunters with the autonomy of a biotech and the resources of a major pharmaceutical company, aiming to develop future AI-powered operating models for large molecule discovery and accelerate candidate delivery to the clinic. The Nonclinical Safety Lead in AIRx is crucial for owning the safety strategy of the AIRx portfolio. This role involves designing nonclinical safety packages, directing CRO execution, and ensuring data interpretability for AI/ML applications. It's a scientific strategy role combined with a hands-on project toxicologist function within a fast-paced unit, integrated into the Drug Discovery, Medicinal Chemistry, Toxicology, and Automation (DMTA) cycle from early assessment through IND-enabling studies. The ideal candidate is a seasoned nonclinical safety expert comfortable with directing and interpreting study packages, challenging hypotheses based on structural alerts, and utilizing AI-enabled data integration.

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.

Nice To Haves

Board certification or fellowship in toxicology (DABT, ERT, or equivalent) strongly preferred.

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 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.