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  Associate Director, Global Labeling Lead (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 17/04/2026

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  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. br/ br/ I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description br/ br/ About the role: br/ br/ At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. How you will contribute: br/ br/ With guidance from leadership: Management of Labeling Cross-Functional Teams Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. br/ br/ Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. br/ br/ Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. br/ br/ Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. br/ br/ With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. br/ br/ Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. br/ br/ Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). br/ br/ Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. br/ br/ Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. br/ br/ Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. br/ br/ Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. br/ br/ Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. br/ br/ Precedent Search and Labeling Trends Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. br/ br/ Working within Labeling Team and GRA br/ br/ Represents Global Labeling at Global Regulatory Team (GRT) br/ br/ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. br/ br/ Represents global labeling in departmental and cross-functional task-forces and initiatives. br/ br/ Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. br/ br/ Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. br/ br/ Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. br/ br/ Minimum Requirements/Qualifications: br/ br/ BSc degree, preferred; BA accepted. br/ br/ Advanced scientific degree (MSc, PhD, or PharmD) preferred. br/ br/ 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. br/ br/ Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). br/ br/ Knowledge of US and/or EU regulatory requirements and guidelines. br/ br/ Knowledge of other relevant regional regulatory nuances and requirements. br/ br/ Knowledge of scientific principles and regulatory/quality systems relevant to drug development. br/ br/ Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. br/ br/ Ability to develop target labeling profile (TLP) with minimal supervision and guidance. br/ br/ Understanding of the broad concepts within global labeling and implications across the organization and globally. br/ br/ Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. br/ br/ More about us: br/ br/ At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as remote following Takedas Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We 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: Massachusetts - Virtual br/ br/ U.S. Base Salary Range: $154,400.00 - $242,550.00 The 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 medic Read Less

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  Research Scientist AI/ML Foundational Models - Pioneering Next-Gen Therapeutic Discoveries (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 17/04/2026

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  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. br/ br/ I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they dont. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives and help shape how AI delivers real impact in drug discovery, wed like to hear from you.Position Overview:We are seeking Scientists to develop and deploy foundational AI models that will transform drug discovery across Takeda. As part of the AI/ML Foundation team, you will build large-scale models including large language models (LLMs), diffusion models, and multimodal architectures that integrate diverse data types—omics, biomedical imaging, protein 3D structures, and molecular representations. This role requires deep expertise in modern deep learning architectures combined with foundational knowledge of biology, chemistry, and disease biology to ensure models are scientifically grounded and impactful. You will train models from scratch, fine-tune pre-trained models for Takeda-specific applications, and deploy foundation model capabilities that accelerate discovery across all therapeutic platforms.Accountabilities:Develop and train foundational AI models (LLMs, diffusion models, flow-matching architectures) for drug discovery applications, with capability to pre-train on large-scale scientific corpora and molecular datasets.Fine-tune and adapt pre-trained foundation models (protein language models, chemical LLMs, vision transformers) for Takeda-specific applications in target identification, disease modeling, and molecular design and discovery.Build multimodal foundation models integrating diverse data types including omics (genomics, transcriptomics, proteomics), biomedical imaging, protein 3D structures, and molecular representations.Apply and extend state-of-the-art approaches including graph neural networks, transformer-based protein language models, and multimodal learning frameworks.Apply domain expertise in biology, chemistry, and/or disease biology to guide model architecture decisions, training data curation, and evaluation strategies ensuring scientific validity.Implement state-of-the-art generative architectures (diffusion, score-based models, autoregressive transformers) for molecular generation, protein design, and multi-objective optimization.Collaborate with computational scientists across domains to deploy foundation models that address diverse discovery needs across small molecules, biologics, and emerging modalities.Stay current with advances in foundation models, generative AI, and multimodal learning; contribute to internal knowledge sharing and external publications.Education Requirements:PhD in Computer Science, Machine Learning, Computational Biology, Bioinformatics, or related field or MS with 6+ years relevant experience, or BS with 8+ years relevant experienceDeep expertise in modern deep learning architectures including transformers, diffusion models, and/or generative models.Strong experience training large-scale models with proficiency in PyTorch and distributed training frameworks.Foundational knowledge of biology, chemistry, or disease biology sufficient to guide scientifically meaningful model development.Experience with at least one of: protein language models (ESM, ProtTrans), molecular generative models, or biomedical vision models.Experience with cloud computing (AWS, GCP) and GPU cluster training at scale.Preferred:Experience building or fine-tuning foundation models in pharmaceutical or life sciences settings.Expertise in multimodal learning integrating text, images, and structured molecular data.Experience with omics data analysis (genomics, transcriptomics, proteomics) and knowledge graphFamiliarity with protein structure prediction and 3D molecular representations.Publications in top-tier ML venues (NeurIPS, ICML, ICLR) or computational biology journals.Experience with model compression, efficient inference, or production deployment of large models.Strong background in large-scale data integration and multimodal modeling for biological systems.Proficiency in Python and ML libraries (PyTorch, TensorFlow, scikit-learn); familiarity with Unix tools.Excellent collaboration and communication skills.ADDITIONAL INFORMATIONThe position will be based in Cambridge, MATakeda 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:$116,000.00 - $182,270.00The 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 TypeFull timeJob 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. Read Less

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  Senior Director, Clinical Data Standards (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 17/04/2026

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  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. br/ br/ I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations Standards.At Takeda, we are transforming the pharmaceutical industry through our R D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.Here, you will be a necessary contributor to our inspiring, bold mission.GOALS:In collaboration with the Clinical Data Strategy Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives strategy of Takeda’s global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability.Responsible for establishing and managing a Standards vendor to support Standards Management vision. Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough assessment of library enhancements and deviations.Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation.Participates with and influences at industry standards forums in support of Takeda’s therapeutic areas.Serves as a resource to support questions raised by regulatory agencies.ACCOUNTABILITIES:Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum.Works with Clinical Data Strategy Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy.Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization.Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives.Supervises staff and vendors developing standards library to ensure alignment to standards strategy.Develops training strategy and ensures consistent training program for standards.Provides senior oversight to vendor/CROs for utilization of Takeda standards.Conducts ongoing review and development of metrics to assess standards utilization and development trends.Oversees Standards Governance, managing deviations from standards content and processes.Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc.Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization.Complies with all applicable regulatory expectations.​EDUCATION AND EXPERIENCE:BS/BA or MS in a life science or analytical area.12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field.8+ years of experience supporting clinical trials across all phases of development.5+ years of progressive management experience.Proven track record for development and management of a standards library.In-depth knowledge of data management systems and processes, analysis and reporting principles.Good knowledge of statistical programming languages (e.g. SAS).Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS.Expertise in the requirements and technology required to support electronic data capture and electronic submissions.Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.Proven track record in managing global, cross-functional standards and processes.Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.)Able to influence without authority.Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.Pragmatic and willing to drive and support change.Is comfortable with ambiguity .Support a culture of continual improvement and innovation; promote knowledge sharing.Takeda 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:Massachusetts - VirtualU.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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob 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. br/ br/ #LI-Remote Read Less

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  Director, Head of High-Throughput in vitro ADME (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 17/04/2026

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  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. br/ br/ I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.Objective / Purpose: The Director, High-Throughput In Vitro ADME is a senior scientific and operational leader responsible for building and directing Takeda’s high-throughput in vitro ADME capabilities in support of small- and large-molecule discovery programs.Reporting to the Head of Drug Discovery Lab Automation and Transformation, this Director will define strategy, oversee operations, and drive technology innovation at the interface of ADME science, laboratory automation, and robotics. The organization will operate as a service-oriented group, delivering robust, high-quality ADME data to enable rapid, high-confidence decision-making in Design–Make–Test–Analyze (DMTA) cycles across the portfolio.Accountabilities: Strategic Leadership VisionDefine and execute the multi-year strategic roadmap for high-throughput in vitro ADME at Takeda, aligned with the broader vision of the Drug Discovery Lab Automation and Transformation organization.Shape an enterprise-level, service-oriented operating model for ADME, ensuring capacity, capability, and flexibility to meet evolving project and portfolio needs.Champion innovation in high throughput assay design, detection technologies, automation, and data workflows to enhance throughput, quality, and cost-effectiveness.Team Leadership People DevelopmentLead, mentor, and grow a team of scientists and research associates responsible for the routine delivery of a comprehensive suite of in vitro ADME assays.Build a culture of scientific rigor, operational excellence, safety, and customer focus, supported by clear KPIs (e.g., cycle time, success rate, capacity utilization, cost-per-data point).Drive talent development and performance management appropriate for a Director-level organization.High-Throughput ADME OperationsOversee design, execution, and continuous improvement of a broad high throughout in vitro ADME panel, including but not limited to:Metabolic stability and clearance (microsomes, hepatocytes, S9)CYP inhibition and inductionPermeability (e.g., Caco-2, MDCK, PAMPA)Plasma protein and tissue bindingTransporter and other mechanistic assaysEnsure robust support for both small-molecule and large-molecule modalities, adapting methods for new modalities and platforms as the portfolio evolves.Own and maintain fit-for-purpose validation, QC, and SOP frameworks, including root-cause analysis and corrective actions for assay or system deviations.Laboratory Automation, Robotics MiniaturizationProvide scientific and strategic leadership for laboratory automation and robotics within the in vitro ADME space, in close alignment with the Head of Drug Discovery Lab Automation and Transformation.Lead assay miniaturization up to 1536-well formats, from feasibility and optimization through technology transfer into robust, routine operation.Oversee integration of liquid handlers, plate handlers, robotic arms, incubators, readers, and scheduling software into end-to-end automated workflows.Partner with internal automation/engineering and informatics teams to ensure seamless connectivity between instruments, LIMS/ELN, data pipelines, and analytical platforms.Cross-Functional CollaborationServe as the primary ADME service leader interfacing with DMPK, medicinal chemistry, biology, pharmacology, translational sciences, and data science.Translate portfolio and project needs into clear ADME assay strategies, capacity plans, and timelines; communicate priorities, risks, and trade-offs with transparency at project and governance levels.Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities.Quality, Compliance Continuous ImprovementEnsure scientific quality, data integrity, and safety in all ADME operations, consistent with Takeda policies and relevant regulatory expectations.Define and monitor KPIs for throughput, on-time delivery, reproducibility, and cost; apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement.Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues. br/ br/ Education and Experience:Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or M.S. with 16+ years; or B.S. with 18+ years in pharmaceutical/biotech R D.Extensive expertise in in vitro ADME, including method development, validation, and deployment across core assay types.Direct experience in an organization providing ADME services (e.g., CRO or internal ADME service group), with a strong service- and customer-oriented mindset.Proven leadership experience at the Director level, managing scientific teams and complex operations in a high-throughput environment.Demonstrated strategic and hands-on experience with laboratory automation and robotics, including selection, implementation, and lifecycle managemet.Successful track record in miniaturizing ADME assays formats, including optimization for data quality, robustness, and throughput.Experience supporting both small- and large-molecule discovery programs.Familiarity with LIMS/ELN, instrument integration, and data analysis/visualization tools in a high-throughput setting.Proven track record of:Building or transforming high throughput ADME capabilities (e.g. establishing new platforms, scaling capacity, modernizing legacy workflows.Understanding how ADME outputs integrate with DMPK, PK/PD and translational strategies and inform decision makingExperience with data science and process optimization approaches to support advanced analytics, and continuous improvementADDITIONAL INFORMATIONThe position will be based in Cambridge, MA. br/ br/ 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:$177,000.00 - $278,080.00The 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 Read Less

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  Senior Manager Inflammatory Disease Research - Immunology (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 17/04/2026

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  By clicking the “Apply” button, I understand that my employment applic... Read More

  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. br/ br/ I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide.Objective / Purpose: The GI-Drug Discovery Unit at Takeda is a team of experienced, innovative and collaborative drug discovery scientists building an industry-leading portfolio of drugs for inflammatory and GI diseases with high unmet medical need. We are seeking a leader with significant experience in building and leading biology and cross-functional drug discovery teams to establish a new group focused on chronic autoimmune diseases. The Director Inflammatory Drug Discovery Will be responsible for developing industry-leading therapeutics for patients with inflammatory diseases by leading a research group focused on drug development from target identification through to candidate selection.Will recruit, retain, and develop a large team of world class, highly innovative in vitro and in vivo research biologists focused on understanding the molecular, cellular and organ-level drivers of inflammatory disease processes, and identifying and developing drug candidates. br/ br/ Will be scientific research thought leader within the Drug Discovery Unit (DDU), working within a highly matrixed environment to build an industry-leading preclinical and early clinical therapeutic pipeline for Inflammatory Diseases.Will set the discovery portfolio goals for high priority autoimmune diseases and ensure alignment with key stakeholders in inflammatory disease research, the clinical development team, and other Takeda stakeholders. Will be accountable for defining the preclinical elements of multiple drug discovery programs, in partnership with other research leaders across Takeda and the early clinical development team within the GI and Inflammation Therapeutic Area.Will interface with the business development group to identify strategically important innovative external opportunitiesWill help maintain the Takeda culture that promotes creativity, open communication, collaboration, collegiality, and a high sense of urgency. Maintain the highest quality of scientific foundations of the company’s drug discovery process. Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified. br/ br/ Forms a strong partnership with clinical and commercial team colleagues for disease area strategic alignment and is accountability for formulation and delivery of mid-long term innovative strategies to build a sustainable and innovative Inflammation disease area pipeline The Director Inflammation Drug Discovery will lead a team of researchers in early target discovery through candidate selection and partner with the therapeutic area Translational team in the development and delivery of robust early development plans supporting programs through early clinical proof-of-concept.The appointee will partner with the Center for External Innovation at Takeda for the identification and assessment of external platform and pipeline opportunities and be accountable for due diligence evaluation and recommendations on external opportunities in Inflammation diseases. Is seen as an international subject matter expert and identified as a global Takeda thought leader in the field of Inflammatory disease research and keeps up up-to-date with scientific, drug discovery and development and the external competitive environment. Represents Takeda and fosters a presence in the global inflammation and immunology scientific community through scientific meetings. Ensures and encourages diversity and supports individual colleagues and their reports in career development. Ensure that all Inflammation disease area Global Product Teams are resourced for optimal scientific support for research studies, mechanistic understanding, disease area evolution and competitive landscape understanding. Provides nuanced and well-informed advice to senior stakeholders about the GI and Inflammation therapeutic landscape, providing direction on where the science will lead. Leadership Creative, collaborative, proactive and confident individual with proven leadership qualities, as demonstrated by performance. Demonstrated ability to work across functions, regions and cultures and adheres to Takeda’s valuesExcellent communicator, able to persuasively convey both ideas and data, orally, in presentation and written format Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Interaction Effectively navigates the dynamics of external and internal environments and leads others by creating and inspiring and engaging workplace. Cultivates a broad network of relationships throughout Takeda, with affiliates and external partnersEffectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions. Innovation Creative scientific thinker with excellent understanding of emerging technologies that enhance disease understanding and human-focused drug development programsIdentifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the disease area-specific competitive landscape Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation. Ability to take risks implementing innovative solutions, accelerating time to market. Comfortable challenging the status quo and bringing forward innovative solutions. Role models respect and inclusion, creating a culture that fosters innovation. Education Competencies (Technical and Behavioral): PhD degree in Immunology or a closely related discipline with 10+ years drug development experience in highly competitive biopharmaceutical companies or MS with 16+ years experience, or BS with 18+ years experience Expert scientific knowledge in autoimmune and inflammatory disease research with experience in lymphocyte biology is highly desiredHighly experienced in exploratory drug development with proven biopharmaceutical industry experience leading innovative therapeutic programs and with expertise in small molecule and/or biologics drug development10 years of direct line management and cross-functional project leadership experience required Highly knowledgeable and experienced in all aspects of Inflammation Disease drug discovery through to candidate selection/IND, including contributing to regulatory documentation. Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage matrix teams to maximize the organizational productivity. Has strong leadership skills and acumen. Has excellent written and verbal communication skills in English. Capable of leading a matrixed team comprised of scientists from within Takeda as well as external collaborators. Has significant experience of participation in BD diligence activities in the preclinical discovery function ADDITIONAL INFORMATIONThe position will be based in Cambridge, MA. br/ br/ This position is currently classified as “hybrid” by Tak Read Less

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  Global Regulatory Affairs Labeling Director (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 17/04/2026

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  By clicking the “Apply” button, I understand that my employment applic... Read More

  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. br/ br/ I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description br/ br/ About the role: br/ br/ At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. How you will contribute: br/ br/ With guidance from leadership: Management of Labeling Cross-Functional Teams Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. br/ br/ Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. br/ br/ Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. br/ br/ Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. br/ br/ With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. br/ br/ Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. br/ br/ Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). br/ br/ Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. br/ br/ Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. br/ br/ Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. br/ br/ Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. br/ br/ Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. br/ br/ Precedent Search and Labeling Trends Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. br/ br/ Working within Labeling Team and GRA br/ br/ Represents Global Labeling at Global Regulatory Team (GRT) br/ br/ Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. br/ br/ Represents global labeling in departmental and cross-functional task-forces and initiatives. br/ br/ Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. br/ br/ Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. br/ br/ Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. br/ br/ Minimum Requirements/Qualifications: br/ br/ BSc degree, preferred; BA accepted. br/ br/ Advanced scientific degree (MSc, PhD, or PharmD) preferred. br/ br/ 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. br/ br/ Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). br/ br/ Knowledge of US and/or EU regulatory requirements and guidelines. br/ br/ Knowledge of other relevant regional regulatory nuances and requirements. br/ br/ Knowledge of scientific principles and regulatory/quality systems relevant to drug development. br/ br/ Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. br/ br/ Ability to develop target labeling profile (TLP) with minimal supervision and guidance. br/ br/ Understanding of the broad concepts within global labeling and implications across the organization and globally. br/ br/ Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. br/ br/ More about us: br/ br/ At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as remote following Takedas Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We 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: Massachusetts - Virtual br/ br/ U.S. Base Salary Range: $154,400.00 - $242,550.00 The 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 medic Read Less

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  Director, Head of High-Throughput in vitro ADME (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 16/04/2026

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  By clicking the “Apply” button, I understand that my employment applic... Read More

  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 DescriptionAt Takeda, we are a forward-looking, world-class R communicate priorities, risks, and trade-offs with transparency at project and governance levels.Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities.Quality, Compliance apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement.Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues. Education and Experience:Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or M.S. with 16+ years; or B.S. with 18+ years in pharmaceutical/biotech R Read Less

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  Senior Manager, International Labeling Strategy (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 16/04/2026

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  By clicking the “Apply” button, I understand that my employment applic... Read More

  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 DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.Working within Labeling Team and GRARepresents Global Labeling at Global Regulatory Team (GRT)Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.Represents global labeling in departmental and cross-functional task-forces and initiatives.Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.Vendor ManagementOversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.Continuous ImprovementActively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.Minimum Requirements/Qualifications:BSc degree, preferred; BA accepted.Advanced scientific degree (MSc, PhD, or PharmD) preferred.8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).Knowledge of US and/or EU regulatory requirements and guidelines.Knowledge of other relevant regional regulatory nuances and requirements.Knowledge of scientific principles and regulatory/quality systems relevant to drug development.Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance.Ability to develop target labeling profile (TLP) with minimal supervision and guidance.Understanding of the broad concepts within global labeling and implications across the organization and globally.Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as remote following Takedas Hybrid and Remote Work policy.Takeda 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:Massachusetts - VirtualU.S. Base Salary Range:$154,400.00 - $242,550.00The 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 medic Read Less

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  Executive Director, Data Management and Standards (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 16/04/2026

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  By clicking the “Apply” button, I understand that my employment applic... Read More

  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 DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations takes measured risks; thinks outside the box; challenges the status quo.Pragmatic and willing to drive and support change.Is comfortable with ambiguity .Support a culture of continual improvement and innovation; promote knowledge sharing.Takeda 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:Massachusetts - VirtualU.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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob 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. #LI-Remote Read Less

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  Chief of Bioanalytical Drug Metabolism (BOSTON)  

  Takeda Pharmaceutical Company Ltd

  - Suffolk County

  Posted: 16/04/2026

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  By clicking the “Apply” button, I understand that my employment applic... Read More

  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 DescriptionAt Takeda, we are a forward-looking, world-class R communicate priorities, risks, and trade-offs with transparency at project and governance levels.Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities.Quality, Compliance apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement.Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues. Education and Experience:Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or M.S. with 16+ years; or B.S. with 18+ years in pharmaceutical/biotech R Read Less

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