Logistics

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

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 Description 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 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 & Vision Define 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 Development Lead, 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 Operations Oversee 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 induction Permeability (e.g., Caco-2, MDCK, PAMPA) Plasma protein and tissue binding Transporter and other mechanistic assays Ensure 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 & Miniaturization Provide 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 Collaboration Serve 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 Improvement Ensure 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. 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 making Experience with data science and process optimization approaches to support advanced analytics, and continuous improvement ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Takeda’s 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: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 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 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 Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for

  • Cambridgeport, MA

  • no content

Machine Learning Researcher for Foundational Models (BOSTON)

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 Description 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 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 don't. 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, we'd 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 experience Deep 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 graph Familiarity 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 INFORMATION The position will be based in Cambridge, MA 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: Boston, MA U.S. Base Salary Range: $116,000.00 - $182,270.00 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 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 Statement Takeda 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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.

  • Cambridgeport, MA

  • no content

Chief of Bioanalytical Drug Metabolism (BOSTON)

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 Description 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 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 & Vision Define 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 Development Lead, 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 Operations Oversee 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 induction Permeability (e.g., Caco-2, MDCK, PAMPA) Plasma protein and tissue binding Transporter and other mechanistic assays Ensure 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 & Miniaturization Provide 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 Collaboration Serve 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 Improvement Ensure 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. 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 making Experience with data science and process optimization approaches to support advanced analytics, and continuous improvement ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Takeda’s 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: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 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 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 Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for

  • Cambridgeport, MA

  • no content

Head of Clinical Data Integration (BOSTON)

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 Description Are 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. A CCOUNTABILITIES: 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 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 U.S. Base Salary Range: $212,000.00 - $333,190.00 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 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 Statement Takeda 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. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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

  • Boston, MA

  • no content

Research Scientist AI/ML Foundational Models (BOSTON)

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 Description 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 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 don't. 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, we'd 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 experience Deep 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 graph Familiarity 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 INFORMATION The position will be based in Cambridge, MA 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: Boston, MA U.S. Base Salary Range: $116,000.00 - $182,270.00 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 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 Statement Takeda 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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.

  • Cambridgeport, MA

  • no content

Director, Global Regulatory Affairs CMC (BOSTON)

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 Description About the role: 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. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Acts as mentor / coach to other GRA CMC members. How you will contribute: Develops, executes and oversees the preparation of major global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters. Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Providing strategic input into change control evaluation - as required. As a GRA CMC member, ensures and / or enhances regulatory compliance. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Proactively identifies regulatory CMC risks, ensuring timely communication with line management. Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target. Supports development of strategies, tools, and trainings to further the GRA CMC roadmap. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required. 10 years of overall biopharmaceutical/device industry experience with 8 years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Applies direction taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. 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 hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 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: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 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 medical, dental, vision insurance, a 401(k) plan and company match, short-term and lon

  • Cambridgeport, MA

  • no content

Senior Director, Clinical Data Standards (BOSTON)

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 Description Are 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. A CCOUNTABILITIES: 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 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 U.S. Base Salary Range: $212,000.00 - $333,190.00 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 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 Statement Takeda 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. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It 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

  • Boston, MA

  • no content

Executive Director, Global Regulatory Affairs - Oncology (BOSTON)

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 Description About the role: 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. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs. How you will contribute: Lead global regulatory strategy for assigned programs across development stages. Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients Will be responsible for complex and potentially multiple projects within the Oncology TAU. Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives. Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise. Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products. When necessary, seeks expert advice and technical support from functional stakeholders and senior management. Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members. Ensures alignment of global regulatory strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary FDA point of contact for projects of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. May oversee execution. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). Minimum Requirements/Qualifications: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 12 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8 years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 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 hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 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: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 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 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,

  • Cambridgeport, MA

  • no content

Vice President, Oncology Regulatory Strategy (BOSTON)

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 Description About the role: 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. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs. How you will contribute: Lead global regulatory strategy for assigned programs across development stages. Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients Will be responsible for complex and potentially multiple projects within the Oncology TAU. Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives. Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise. Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products. When necessary, seeks expert advice and technical support from functional stakeholders and senior management. Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members. Ensures alignment of global regulatory strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary FDA point of contact for projects of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. May oversee execution. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). Minimum Requirements/Qualifications: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 12 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8 years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. 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 hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 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: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 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 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,

  • Cambridgeport, MA

  • no content

Chief Utility Systems Electrician (SOCIAL CIRCLE)

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 Description About the role: The Utilities Technician - electrician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies. How you will contribute: Perform preventive, corrective and predictive maintenance of all associated equipment. Operate and maintain various equipment through routine inspection and review. All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies. Read, understand, and follow related SOPs and job/work plans. Ensure that forms and work order documentation are completed with accurate information. Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises. Provide support for the start-up of new equipment to ensure it meets all electrical design specifications. Repair, replace and install sensors, actuators, transformers, controllers, circuit breakers, motors, heating units, electric eyes, conduit systems, switches, defective writing, etc. Troubleshoot, repair, and replace PLCs, Servo and Frequency Drives, and related electronic hardware Disassembles, inspects, reassembles, troubleshoots, repairs, and replaces malfunctioning parts or equipment (motors, switches, sensors, input /output boards, controllers servos, gears, sprockets chains, knives, etc. using test equipment Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws. Perform Disposal of Hazardous Waste Respond to urgent and emergency work orders for the utilities department as needed. Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP). Attend required Instructor Lead Training and planned team meetings Demonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving. Keeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain) Ability to teach basic activities and work execution to other technicians. This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician. Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments. May perform other duties as assigned. What you bring to Takeda: Typically requires a high school diploma or GED plus 8 years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred. Two-year certificate in a technical field such as Electrician Proficiency in electrical circuits, schematics, servo motors, and familiarity with 460/220 3 PH wiring. HVAC, building trades or building utilities program, or equivalent military experience is preferred. 5-6 years of experience in the maintenance trades is preferred Ability to read and understand technical manuals and wiring schematics Must have good customer service skills and promote a teamwork environment Ability to effectively communicate ideas through verbal and written form. Intermediate computer skills. Ability to interact constructively with peers and other teams. Ability to seek outside resources as needed. Ability to read and understand procedures, schematics, and job blueprints. Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps. Operate general laboratory equipment to assess the analytical status of the utilities process. Familiar with CMMS, SAP, JDE, and or Maximo Must be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. May be exposed to sunlight and heat. May be exposed to dust, gases, and fumes. May be required to stand and walk frequently while evaluating utilities equipment. May be around moving equipment and machinery. May climb up and into large tanks for inspection. May work in a loud area that requires hearing protection and other protective equipment to be worn. May be required to work or be assigned to a different shift as needed. Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts. Overtime may be required at times. Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities. May be required to lift up to 50 pounds when managing chemicals. No travel is expected with this position. 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. GMSGQ ZR1 LI-MA1 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: USA - GA - Social Circle - Hwy 278 U.S. Hourly Wage Range: $27.55 - $43.26 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match

  • Social Circle, GA

  • no content

Head of Regulatory Strategy, Global Neuroscience (BOSTON)

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 Description About the role: 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. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio . This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams . Defines , develops , and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations . Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Participates in cross- functiona l initiatives within Global Regulatory Affairs and Takeda R&D . How you will contribute: The Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs. Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 10 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Acceptable and independent skills in the area of regu

  • Cambridgeport, MA

  • no content

Senior Maintenance Technician - Electrician - Expert in High-Pressure Steam Boiler Systems (SOCIAL CIRCLE)

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 Description About the role: The Utilities Technician - electrician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies. How you will contribute: Perform preventive, corrective and predictive maintenance of all associated equipment. Operate and maintain various equipment through routine inspection and review. All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies. Read, understand, and follow related SOPs and job/work plans. Ensure that forms and work order documentation are completed with accurate information. Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises. Provide support for the start-up of new equipment to ensure it meets all electrical design specifications. Repair, replace and install sensors, actuators, transformers, controllers, circuit breakers, motors, heating units, electric eyes, conduit systems, switches, defective writing, etc. Troubleshoot, repair, and replace PLCs, Servo and Frequency Drives, and related electronic hardware Disassembles, inspects, reassembles, troubleshoots, repairs, and replaces malfunctioning parts or equipment (motors, switches, sensors, input /output boards, controllers servos, gears, sprockets chains, knives, etc. using test equipment Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws. Perform Disposal of Hazardous Waste Respond to urgent and emergency work orders for the utilities department as needed. Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP). Attend required Instructor Lead Training and planned team meetings Demonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving. Keeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain) Ability to teach basic activities and work execution to other technicians. This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician. Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments. May perform other duties as assigned. What you bring to Takeda: Typically requires a high school diploma or GED plus 8 years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred. Two-year certificate in a technical field such as Electrician Proficiency in electrical circuits, schematics, servo motors, and familiarity with 460/220 3 PH wiring. HVAC, building trades or building utilities program, or equivalent military experience is preferred. 5-6 years of experience in the maintenance trades is preferred Ability to read and understand technical manuals and wiring schematics Must have good customer service skills and promote a teamwork environment Ability to effectively communicate ideas through verbal and written form. Intermediate computer skills. Ability to interact constructively with peers and other teams. Ability to seek outside resources as needed. Ability to read and understand procedures, schematics, and job blueprints. Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps. Operate general laboratory equipment to assess the analytical status of the utilities process. Familiar with CMMS, SAP, JDE, and or Maximo Must be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. May be exposed to sunlight and heat. May be exposed to dust, gases, and fumes. May be required to stand and walk frequently while evaluating utilities equipment. May be around moving equipment and machinery. May climb up and into large tanks for inspection. May work in a loud area that requires hearing protection and other protective equipment to be worn. May be required to work or be assigned to a different shift as needed. Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts. Overtime may be required at times. Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities. May be required to lift up to 50 pounds when managing chemicals. No travel is expected with this position. 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. GMSGQ ZR1 LI-MA1 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: USA - GA - Social Circle - Hwy 278 U.S. Hourly Wage Range: $27.55 - $43.26 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match

  • Social Circle, GA

  • no content