AIRx, Sr. Director, Nonclinical Safety Lead

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda 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.PurposeIn 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.AIRx Leadership CapabilitiesThrive in an environment with laser focus on delivery of differentiated candidates to the clinicAccountable leaders who act with decisive judgment; they show agency, move work forward without waiting to be told, and make sound decisions with urgencyBuilders of momentum, not bureaucracy; they advance programs through expertise, surface the best thinking quickly, and create conditions for decisionsGenerative thinkers with a learning orientation — curious, constructive, truth-seeking. They embody "learn-it-all vs know-it-all", fail fast and learn faster, and create inclusive environments with the psychological safety to surface all contributionsSystems thinkers who look forward — they see the whole R&D system, anticipate inflection points, and lead through cross-disciplinary integrationValues-led under pressure — they act in the best interests of patients and Takeda and are always team playersChange leaders who challenge norms and empower others — they are role models for the culture AIRx is creating; challenging when the norm reduces impact and staying ready for rapid shiftsFluent in the hybrid biopharma reality — comfortable at the wet/dry interface of lab science and AI/data/engineering; instinctive about where value inflects across the discovery-to-development continuumExternally oriented — they tap into external KOL networks, contribute meaningfully to business development, and monitor the competitive and regulatory landscape to inform decisionsDeep experts in their domain — with in-depth, current knowledge of their discipline and a restless drive to advance itImpactful communicators who create alignment — confident in high-stakes, ambiguous settings; bridging across boundaries and keeping colleagues anchored to the missionNonclinical Safety Lead AccountabilitiesOwn 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 pathwayDesign 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 progressionIntegrate 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 useLead 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 investmentOversee repeat-dose, genetic toxicology, safety pharmacology studies as programs progress; ensure GLP studies are scoped correctly and delivered on time and to qualityAuthor and review nonclinical sections of INDs, CTAs, and key regulatory briefing documents; serve as Takeda's scientific representative in regulatory interactions concerning non-clinical safetyCollaborate 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 dosesStay current with evolving regulatory guidance (FDA, EMA, ICH) on nonclinical safety requirements; proactively assess and communicate implications for AIRx program timelines and study designsContribute 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 generationShape 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 modelQualifications & CompetenciesExpected Requirements:PhD in toxicology, pharmacology, biochemistry, or closely related discipline; board certification or fellowship in toxicology (DABT, ERT, or equivalent) strongly preferred12–15+ 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 projectsStrong 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 studiesDeep expertise in genetic toxicology, repeat-dose toxicology, safety pharmacology (core battery and supplemental), immunotoxicology; working knowledge of phototoxicity, reproductive and developmental toxicologyProficiency 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 profilingTrack record designing, directing, and critically interpreting externalized CRO GLP and non-GLP safety study packagesAbility to succinctly and effectively summarize the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocolsExperience working at the DMPK/toxicology interface: TK analysis, metabolite profiling, safety margin assessment, and species selection rationaleAI/ML data literacy; comfortable working with large multi-source safety datasets and integrating in silico predictions with experimental outputs in a DMTA contextDeep 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 forumsADDITIONAL INFORMATIONThe position will be based in Cambridge, MA. This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policyTakeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$212,000.00 - $333,190.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Reference: R0183005