Takeda Pharmaceutical

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 OBJECTIVES/PURPOSE Responsible for driving the strategy for Takeda's global data standards, processes, and technologies across the clinical data continuum for quality of deliverables and global data interoperability. Actively participates in and influences Data Standards forums (internally or externally) to maintain awareness of any initiatives and trends that could be incorporated into or enhance Takeda's Therapeutic Area Clinical Data Standards Library. Supports enforcement of Takeda's Global Data Standards Governance to ensure proper utilization of standards, adherence to standards processes, and the timely, thorough assessment of library enhancements and deviations. Actively leads the identification, review/evaluation, deployment and usage of technologies to generate, distribute, and/or integrate with and report on standards compliance internally, and manages in-house programs along with standards vendor(s) to support Standards Management vision. Builds relationships across the global Takeda organization and with CROs/strategic service providers, provides project management leadership of standards projects and has the ability to partner closely with internal/external standards stakeholders, and serves as a resource to support questions raised by regulatory agencies. ACCOUNTABILITIES In collaboration with the Cross-functional SET and TAU Leaders, establishes and drives strategy of Takeda's global data standards, processes, and technologies across the clinical data continuum ensuring quality of deliverables and global data interoperability. Develops the standards library (e.g., Veeva CDMS, Edit Checks, DTS, eCOA, IRT, CDISC, ADaM, TLFs) and ensures proper utilization of standards, adherence to all standards processes, and the timely, thorough assessment of library enhancements and deviations through Standards Governance. Builds relationships across the global Takeda organization and CRO partners in support of the standards vision and implementation. Has advanced knowledge of all standard library components and metadata across data collection, analysis, and reporting continuum and serves as a resource to support questions raised by regulatory agencies. Has a demonstrated understanding of clinical data capture/management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC, EHR, eCOA, IRT, CDR, MDR, SCE and adjacent systems. Has strong working knowledge of clinical study processes and related regulatory requirements or information governance frameworks, (e.g., 21 CFR Parts 11, 312, 314, Good Clinical Practice ICH-GCP E6 R2 , Good Clinical Data Management Practices, HIPAA, GDPR, etc.). Supervises staff and vendors developing standards library elements to ensure alignment to standards strategy. Develops training strategy and ensures consistent training program for standards. Oversees Standards Governance, manages deviations from standards content and processes, conducts periodic review and development of various metrics including assessment of standards utilization and development trends. Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, Phuse, Transcelerate, SCDM, EDC users group, SAS users group, etc. Actively communicates and ensures compliance with submission standards and guidance documents, regulatory agency expectations and industry trends as applicable to the Takeda organization. Actively participates and contributes at industry standards forums in support of Takeda's assets. CORE ELEMENTS RELATED TO THIS ROLE Leads a team to effectively govern and build standards library, align with leadership on operational strategy and engage stakeholders. Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations. Proven track record in development and management of standards library and in-depth knowledge of study design through submission EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: BS/BA or MS in a life science or analytical area with over 12 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation. Minimum 12 years of clinical data management and/or database or statistical programming experience in pharmaceutical industry or health related field. Thorough knowledge and understanding of standards development processes, focused on clinical data with a strong knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global privacy regulations. Proven track record for development and management of standards library in addition to in-depth knowledge of study design implementation, to define standards eCRFs, edit checks, best practices in EDC and other data acquisition sources. knowledge of statistical programming languages (e.g., SAS, R, Python, etc.). Desirable CDM technical expertise (e.g., EDC Veeva and/or Rave, elluminate). 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, support a culture of continual improvement and innovation; promotes knowledge sharing. 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 and comfortable with ambiguity. Direct experience in the pharmaceutical industry or related field required. Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering programs with complex business deliverables. Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. This position is currently classified as "remote" 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: Massachusetts - Virtual U.S. Base Salary Range: $174,500.00 - $274,230.00 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. LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&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. As an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. 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 develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. 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. 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. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8+ 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 solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. 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" in accordance with 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: $153,600.00 - $241,340.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime Type Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions. Precedent Search and Labeling Trends Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience. Strategic Thinking Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately escalate to leadership. Technical In-depth expertise of US and EU product labeling requirements, regulations, and guidelines. - Advanced knowledge of US and/or EU regulatory requirements and guidelines and proactive evaluation of evolving regulatory labeling landscape. Understanding of other relevant regional regulatory nuances and requirements. Understanding of scientific principles and regulatory/quality systems relevant to drug development. Ability to independently create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions. . click apply for full job details

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&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: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can 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 GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. How you will contribute: With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. 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. Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. 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.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). 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. 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 supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies decisions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies the 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. 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: $153,600.00 - $241,340.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&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. 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: $174,500.00 - $274,230.00 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 . click apply for full job details

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 DescriptionRole Summary Lead the strategy, platform build-out, and adoption of AI/ML across Research for global digital transformation effort, making AI agents, models, and tools a daily, accessible part of wet lab and dry lab scientists' workflows. Translate AF priorities into a practical, compliant AI services layer-data foundations, MLOps, agentic assistants, model governance, and change enablement-that shortens time from experiment to insight and elevates decision quality across discovery programs. Objectives / Purpose Define and execute a multi year AI/ML roadmap aligned to Research use cases and KPIs. Establish an AI ready data foundation (FAIR-by-design) and scientist facing AI tools embedded in ELN/LIMS/instrument workflows. Institutionalize Responsible AI & GxP-aware governance for production models. Drive adoption through super-user networks, training, and change management to achieve measurable value and ROI. Scope / Impact Global Research scope with cross site collaboration (US/EU/JP). Direct impact on data-to-decision latency, assay/analysis reproducibility, and portfolio productivity. Partner with operations, Computational Sciences & Data Strategy, IT, function leads, and platform teams to deliver outcomes at scale. AccountabilitiesStrategy & Roadmap Own Research's AI/ML strategy and sequencing (MVP scale) across wet lab dry lab integration and self service tools. Align priorities with Research's KPIs and portfolio goals; establish and monitor achievement of success criteria and milestones. Platform, Data & Integration Guide the development of AI ready data foundations (provenance, metadata/ontologies, harmonization) across ELN/LIMS, instruments, imaging, and omics. Integrate platforms (e.g., ELN, SDMS & AI Cloud) to liberate, contextualize, and operationalize lab data for AI/ML. Stand up modern MLOps (CI/CD, registries, experiment tracking, monitoring) and secure service/APIs embedded in workflows. Agentic AI & Productization Design self-service and user-friendly processes for deployment of AI agents for scientists (literature triage, protocol assist, data QC, analysis pipelines, code helpers). Guide engineering efforts to deliver production models (e.g., sequence/structure prediction, assay QC, outlier detection, multimodal analytics). Adoption & Change Enablement Lead adoption via super user networks, training, and communications; co own readiness plans with NCSP. Work with Change Management leads to publish playbooks and guardrails enabling self service AI workflows for scientists. Governance, Risk & Compliance Define and Implement Responsible AI and risk based governance (ALCOA+, validation mindset, audit trails, XAI, privacy/PII controls). Impact & Reporting Own measurable impact (adoption, latency, reproducibility, ROI) and provide transparent reporting to R&D leadership and key stakeholders. QualificationsRequired PhD degree in a scientific discipline with 10+ years experience , or MS with 16+ years experience, or BS with 18+ years experience (preferably in Advanced degree in Computer Science, AI/ML, Computational Biology/Chemistry, Bioinformatics, or related; or equivalent industry experience.) Proven MLOps platform build and delivery of scientist facing AI tools embedded in ELN/LIMS/instrument workflows. Expertise in FAIR data, scientific data models/ontologies, and integration across wet lab instruments, imaging, and omics. Experience with Responsible AI and GxP adjacent validation/governance in pharma/biotech R&D. Strong stakeholder management; ability to translate complex science/data into usable AI for end users. Preferred Experience working in wet-labs and knowledge of Research and Development workflows and processes in either the biologics and/or small molecule fields Agentic AI systems and LLMs for scientific contexts; multimodal ML (text/images/sequences/numerical). Knowledge of Research/Pharma Sci common data models and cloud analytics/HPC integrations. 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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 OBJECTIVES/PURPOSE Create and execute detailed test plans and UAT scripts based on business requirements and technical specifications to verify study/library functionality in EDC system and adherence to standards. Drive study database user acceptance testing activities in a role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system. Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration. Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business. Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing. Develop organizational knowledge of organizational clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration. Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models. Defines and/or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements. Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data deliverables. Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes. Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report and etc. Create and execute standardized test scripts for EDC components, inbound integrations, and data listings. Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected. Lead and coordinate End User Testing Activities, ensure that End User Testers have required training and system access. Communicate actively with management and clinical teams about testing progress and challenges. Support special projects and automated testing activities, including tool identification for manual UAT script automation. Provide technical support, liaising with CDE for troubleshooting and system issue resolution. Collaborate with cross-functional teams and vendors to ensure integration accuracy. Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDM ACCOUNTABILITIES Test Plan and Script Execution: Create and execute detailed test plans and User Acceptance Testing (UAT) scripts, ensuring alignment with business requirements and technical specifications. Validate study/library functionality within EDC systems and confirm adherence to established standards. Testing Strategy Development: Develop and enhance testing strategies for EDC system study/library builds and integrations. Stakeholder Collaboration: Network with key stakeholders to refine and improve study build automation and testing reduction strategies. Leadership in UAT Activities: Lead UAT for studies and libraries, including inbound integrations, using an Agile approach and in accordance with SOPs and processes. Coordinate and oversee End User Testing activities, ensuring testers are adequately trained and have necessary system access. UAT Documentation Development: Develop comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports. Standardized Test Script Creation: Develop and execute standardized test scripts for EDC components, inbound integrations, and data listings. Testing Results Analysis: Record and document test results, comparing them to expected outcomes. Identify software and specification failures for timely defect resolution. Communication and Reporting: Actively communicate with management and clinical teams about testing progress, challenges, and outcomes. Support for Special Projects: Assist in special projects and automated testing initiatives, including the identification of tools for manual UAT script automation. Technical Support and Troubleshooting: Provide technical support, collaborating with Clinical Data Engineering (CDE) for system troubleshooing and issue resolution. Cross-functional Collaboration: Work closely with cross-functional teams and vendors to ensure accuracy and efficiency in system integrations. Expertise in Clinical Data Systems: Demonstrate in-depth knowledge of electronic data capture, clinical data management systems, and related infrastructure. Utilize experience with various EDC systems (e.g., Veeva CDMS, Rave) and related clinical research technologies (e.g., eCOA, IRT, RTSM). S and Rave, Veeva CDB, elluminate Data Central, EHR, eCOA, IRT, RTSM, TSDV, CDR, MDR, SCE and adjacent systems. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS : BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with 10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation. Experience with EDC and clinical data management systems. Familiarity with clinical research technologies (e.g., eCOA, IRT, RTSM). Experience in software testing and quality assurance. Proficiency in Agile methodologies and adherence to SOPs. Understanding of clinical data management processes and regulations. Strong problem-solving skills and attention to detail. Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus. Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables. ADDITIONAL INFORMATION Requires approximately 1 - 2 domestic trips annually and up to 1 international trip. Ability to sit and stand for long periods of time. Carrying, handling, and reaching for objects. Manual dexterity to operate office equipment i.e., computers, phones, etc. This position is currently classified as "remote" 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: Massachusetts - Virtual U.S. Base Salary Range: $153,600.00 - $241,340.00 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 . click apply for full job details

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 GI-Drug Discovery Unit at Takeda is a team of experienced, innovative and collaborative drug discovery scientists building an industry-leading portfolio of drugs for inflammatory and GI diseases with high unmet medical need. We are seeking a leader with significant experience in building and leading biology and cross-functional drug discovery teams to establish a new group focused on chronic autoimmune diseases. The Director Inflammatory Drug Discovery Will be responsible for developing industry-leading therapeutics for patients with inflammatory diseases by leading a research group focused on drug development from target identification through to candidate selection. Will recruit, retain, and develop a large team of world class, highly innovative in vitro and in vivo research biologists focused on understanding the molecular, cellular and organ-level drivers of inflammatory disease processes, and identifying and developing drug candidates. Will be scientific research thought leader within the Drug Discovery Unit (DDU), working within a highly matrixed environment to build an industry-leading preclinical and early clinical therapeutic pipeline for Inflammatory Diseases. Will set the discovery portfolio goals for high priority autoimmune diseases and ensure alignment with key stakeholders in inflammatory disease research, the clinical development team, and other Takeda stakeholders. Will be accountable for defining the preclinical elements of multiple drug discovery programs, in partnership with other research leaders across Takeda and the early clinical development team within the GI and Inflammation Therapeutic Area. Will interface with the business development group to identify strategically important innovative external opportunities Will help maintain the Takeda culture that promotes creativity, open communication, collaboration, collegiality, and a high sense of urgency. Maintain the highest quality of scientific foundations of the company's drug discovery process. Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 - 10 bulleted task statements should be identified. Forms a strong partnership with clinical and commercial team colleagues for disease area strategic alignment and is accountability for formulation and delivery of mid-long term innovative strategies to build a sustainable and innovative Inflammation disease area pipeline The Director Inflammation Drug Discovery will lead a team of researchers in early target discovery through candidate selection and partner with the therapeutic area Translational team in the development and delivery of robust early development plans supporting programs through early clinical proof-of-concept. The appointee will partner with the Center for External Innovation at Takeda for the identification and assessment of external platform and pipeline opportunities and be accountable for due diligence evaluation and recommendations on external opportunities in Inflammation diseases. Is seen as an international subject matter expert and identified as a global Takeda thought leader in the field of Inflammatory disease research and keeps up up-to-date with scientific, drug discovery and development and the external competitive environment. Represents Takeda and fosters a presence in the global inflammation and immunology scientific community through scientific meetings. Ensures and encourages diversity and supports individual colleagues and their reports in career development. Ensure that all Inflammation disease area Global Product Teams are resourced for optimal scientific support for research studies, mechanistic understanding, disease area evolution and competitive landscape understanding. Provides nuanced and well-informed advice to senior stakeholders about the GI and Inflammation therapeutic landscape, providing direction on where the science will lead. Leadership Creative, collaborative, proactive and confident individual with proven leadership qualities, as demonstrated by performance. Demonstrated ability to work across functions, regions and cultures and adheres to Takeda's values Excellent communicator, able to persuasively convey both ideas and data, orally, in presentation and written format Proven skills as an effective team player who can engender credibility and confidence within and outside the company Ability to distil complex issues and ideas down to simple comprehensible terms Demonstrates leadership presence and confidence Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives. Invests time in helping others to enhance their skills and perform at a higher level. Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Interaction Effectively navigates the dynamics of external and internal environments and leads others by creating and inspiring and engaging workplace. Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner. Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions. Innovation Creative scientific thinker with excellent understanding of emerging technologies that enhance disease understanding and human-focused drug development programs Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the disease area-specific competitive landscape Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation. Ability to take risks implementing innovative solutions, accelerating time to market. Comfortable challenging the status quo and bringing forward innovative solutions. Role models respect and inclusion, creating a culture that fosters innovation. Education & Competencies (Technical and Behavioral): PhD degree in Immunology or a closely related discipline with 10+ years drug development experience in highly competitive biopharmaceutical companies or MS with 16+ years experience, or BS with 18+ years experience Expert scientific knowledge in autoimmune and inflammatory disease research with experience in lymphocyte biology is highly desired Highly experienced in exploratory drug development with proven biopharmaceutical industry experience leading innovative therapeutic programs and with expertise in small molecule and/or biologics drug development 10 years of direct line management and cross-functional project leadership experience required Highly knowledgeable and experienced in all aspects of Inflammation Disease drug discovery through to candidate selection/IND, including contributing to regulatory documentation. Shows cross-cultural understanding to utilize the diverse talents and has demonstrated ability to manage matrix teams to maximize the organizational productivity. Has strong leadership skills and acumen. Has excellent written and verbal communication skills in English. Capable of leading a matrixed team comprised of scientists from within Takeda as well as external collaborators. Has significant experience of participation in BD diligence activities in the preclinical discovery function ADDITIONAL 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: $174,500.00 - $274,230.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors . click apply for full job details

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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 that will inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead - Solid Tumor in our Cambridge office. 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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES: Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees. Oversees the development and execution of the Integrated Disease Area Strategy (IDAS) and overall Integrated Global Development Plan (IGDP). Responsible for review of synopses, other relevant clinical study documents and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Responsible for providing guidance to TA leaders on regional specificities within Therapeutic Area. ACCOUNTABILITIES: Clinical Development team participation and leadership Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies. Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles. Directs Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommends scope, complexity and size, which influence the budget of all aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. Accountable for ensuring regional strategies and trade-offs in regional requirements are well articulated in the global strategy documentation and that stakeholders are appropriately briefed. Providing strategic input into global development strategies and plans for all compounds in OTAU. Providing clinical and strategic support to evaluation of external compounds (alliances and in-licensing opportunities) Primary interface with Medical Affairs team for strategy and to support of product commercial efforts Contributing to the creation and maintenance of regional KOL network Providing recommendations for GDT leader nominations and reviewers of external compounds as part of business development efforts Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation Synopsis / Protocol Development, Study Execution, & Study Interpretation Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds. Trial Medical Monitoring Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. External Interactions Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. Responsible for evaluation of external interactions in the context of overall development strategies using complex problem solving in the region but in context of a global environment. Proactive identification of challenges and development of contingency plans as appropriate. Due Diligence, Business Development and Alliance Projects Responsible for evaluation of potential business development opportunities in the region but with the context of a global environment. Conducts due diligence evaluations, of clinical development plans for potential alliances and or in-licensing opportunities. Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner. Assigns and manages clinical science staff who are involved in many of these activities. Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise and in all aspects relating to assigned compound in regional area. Leads TGRD internal teams and global cross-functional teams. Works with functional leadership to prioritize projects within the therapeutic area. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Experience MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies. Experience in conducting and/ or leading multiple clinical trials involving immune based therapies Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment. Demonstrated ability to foster a high-performance culture and build organizational capabilities. Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives. Previous experience in successfully leading several clinical development team/matrix team with responsibility for Global studies in multiple regions. Clinical Development experience beyond US/EU Solid and Multiple experience in preparing and interacting with multiple regulatory agencies including FDA, EMA, and others Multiple NDA/MAA submission experience Proven ability to lead and manage highly trained medical, scientific, and technical professionals. Superior communication, strategic, interpersonal and negotiating skills . click apply for full job details

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 We are seeking a seasoned and visionary Senior Director of Medicinal Chemistry to join our leadership team. This individual will play a pivotal role in shaping the future direction of our company by providing strategic guidance and oversight to our medicinal chemistry efforts. The ideal candidate will be instrumental in driving our drug discovery initiatives forward, ensuring their successful progression and alignment with our company's overall goals and objectives. By leveraging their expertise, they will significantly influence our strategic decisions and contribute to the advancement of our scientific and commercial endeavors. Additionally, this person will oversee external programs at CROs, managing the design, execution, and progression of medicinal chemistry projects conducted exclusively at these organizations Accountabilities: Create business development opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization or specific Therapeutic Area (TA). Leadership and Strategy: Provide strategic leadership and oversight to the medicinal chemistry department, aligning with the company's overall goals and objectives. Project Management: Oversee the design, execution, and management of medicinal chemistry projects conducted exclusively at CROs, ensuring timely progress and high-quality outcomes. Team Development: Mentor and develop a team of internal chemists, fostering a collaborative and innovative work environment. Collaboration: Work closely with cross-functional teams, including biology, pharmacology, and clinical development, to advance drug candidates from discovery through development. Innovation: Drive innovation in medicinal chemistry through the integration of new technologies, methodologies, and best practices. Regulatory Compliance: Ensure all activities comply with relevant regulatory requirements and industry standards. External Partnerships: Build and maintain relationships with external partners, including academic institutions, industry collaborators, and contract research organizations. Education & Competencies (Technical and Behavioral): Expected education and experience: PhD degree in Chemistry, Medicinal Chemistry or related discipline with 15+ years experience in small molecule projects. Proven track record of leading successful drug discovery programs, preferably in large pharma. Leadership Skills: Strong leadership and managerial skills with experience leading and developing high-performing teams. Technical Expertise: Deep understanding of medicinal chemistry principles, drug design, and optimization processes. Communication: Excellent verbal and written communication skills, with the ability to effectively communicate complex scientific concepts to a broad audience. Problem-Solving: Strong analytical and problem-solving skills, with a proactive and innovative approach to challenges. Collaboration: Proven ability to work collaboratively in a cross-functional team environment. Adaptability: Ability to adapt to changing priorities and work effectively in a fast-paced and dynamic environment. Preferred Qualifications: Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable. A proven track record of leading projects that are completely outsourced Publications: A strong publication record in medicinal chemistry or related fields. Patents: Experience with patent filings and intellectual property management. Networking: Established network within the scientific and pharmaceutical community. As part of our global R&D strategy, and unique to the Research organization's strong lab presence in Shonan, Japan, this role may include the opportunity for a temporary or long-term international assignment in Japan, subject to business needs and final candidate selection. Candidates interested in global exposure are encouraged to apply. 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: $208,200.00 - $327,140.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&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. 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: $208,200.00 - $327,140.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegular . click apply for full job details

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: $208,200.00 - $327,140.00 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. LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&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 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 Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs. How you will contribute: Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects. Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility. May lead the global regulatory sub-team (GRT) for assigned projects. May serve as global and/or regional regulatory lead as a member of a GRT Primary FDA contact for projects of responsibility. Accountable for all US FDA submissions and approvals of project(s) 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. Ensure 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. Participate with influence in or leads departmental and cross-functional task-forces and initiatives. May 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). May present to senior management as requested. Participate with influence in or leads departmental and cross-functional task-forces and initiatives. Minimum Requirements/Qualifications: Bachelor's Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred. A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus. Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrate strong skills with increasing independence in the area of regulatory strategy. Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership. 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. 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. 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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. How you will contribute: With guidance from leadership: Management of Labeling Cross-Functional Teams Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. Precedent Search and Labeling Trends Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Represents global labeling in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required). Knowledge of US and/or EU regulatory requirements and guidelines. Knowledge of other relevant regional regulatory nuances and requirements. Knowledge of scientific principles and regulatory/quality systems relevant to drug development. Ability to create, revise and/or update product labeling (i.e. CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. Ability to develop target labeling profile (TLP) with minimal supervision and guidance. Understanding of the broad concepts within global labeling and implications across the organization and globally. Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "remote" following 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: Massachusetts - Virtual U.S. Base Salary Range: $153,600.00 - $241,340.00 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 . click apply for full job details

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 OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takeda's regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc regulatory affairs questions. ACCOUNTABILITIES: Global GRIDS Strategy Development and Realization: In partnership and collaboration with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders, develop and align global GRIDS strategy and roadmap. Execute and track GRIDS strategy through agreed to set of milestones, key deliverables, activities, and monitor progress through metrics. Proactively identify and manage risks and issues. Ensure ongoing stakeholder engagement and awareness throughout. Align and structure internal GRIDS team to enable strategy realization and deliverables. Define team roles and responsibilities and ensure alignment across GRO and other functions to ensure clarity and synergy. Develop and implement team norms and ways of working, driving delivery focus and prioritization. Actively mentor and guide direct reports in the execution of deliverables. Ensure external vendor support for GRIDS activities is clearly defined and, in partnership with Business Operations team, is delivering to specified service level agreements. Actively provide vendor oversight and engage with vendor(s) to ensure process and ways-of-working clarity and adoption. Data Governance and Sustainability: Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data remediation efforts as needed to ensure high data quality. Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. Oversee master data management for regulatory data and partner/ drive connectivity with RD and enterprise systems. GRIDS Data Analytics: Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making for Therapeutic Areas Units (TAUs), regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management. Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested. GRIDS System Business Ownership: Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takeda's global GRIDS systems. Ensure business requirements are identified and adequately translated into system and supporting business process functionality. Support system release management, data migration and validation activities. Collaborate with GRA functions, regions, and local operating companies (LOCs) to drive system adoption and utilization. CORE COMPETENCIES: Strategy Development: Ability to create and implement long-term GRIDS strategies with a forward-thinking approach. Influential Communicator: Exceptional communication skills to articulate complex regulatory data concepts effectively. Collaborative Leader: Strong leadership qualities to guide cross-functional teams and drive organizational change. Innovative Thinker: Proactive in embracing innovation and leveraging technology to enhance RIM processes. Results-Oriented: Focused on achieving measurable outcomes and driving continuous improvement. Analytical Skills: Strong analytical skills to interpret regulatory data and deliver insightful reports and visualizations. QUALIFICATIONS: Minimum Bachelor's Degree, MS preferred; 15+ years of experience in the life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems. Experience in leading global Regulatory Information, Data and Systems capabilities and teams. Credibility and experience engaging at senior levels for the development and alignment of GRIDS strategy. Ability to hold strategic conversations with Regulatory, R&D and enterprise stakeholders regarding global Information Management processes and systems and the regulatory applications and their use within Regulatory execution. Demonstrated experience in designing and implementing RIM digital transformation with proven ability to innovate across business processes and technology solutions. Experience with regulatory processes and technology for submission document authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. Experience with regulatory data standards, such as xEVMPD and IDMP. Deep understanding of the entire R&D value chain, particularly data taxonomies and domain integration. Understanding of global drug development & regulatory processes. Experience with Veeva RIM platform for health authority registration management. Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies, a plus. Proven track record of thought leadership through industry presentations, publications, or other mechanisms, a plus. 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: $208,200.00 - $327,140.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs 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 global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. 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 responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, 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 or leads 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. Education & Competencies: Bachelor's Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ 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 relates 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 strong 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. 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. This position is currently classified as "hybrid" in accordance with 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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&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 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. 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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 We are inviting individuals with deep knowledge of machine learning and artificial intelligence with extensive experience in Generative AI to join us in the ShinrAI Center for AI/ML at Takeda, based in Cambridge, MA. At the ShinrAI Center, we're a team of scientists, engineers, machine learning experts and more, working together to advance the application of artificial intelligence in developing innovative medicine for patients. We like to solve problems, take initiative, pitch in when needed, and enthusiastic for trying new things. We are looking for more curious thinkers who like to tackle challenging, real-world problems in a rewarding environment where your contributions are valued and have a direct impact. We're building a diverse team whose skills, experiences, and backgrounds complement one another. Extensive experience working in Pharma or Biotech is optional. A strong curiosity for a deeper understanding of human health and disease to deliver innovative medicine for patients is a must. ACCOUNTABILITIES: Partners with data science teams, domain experts, and business units to identify and prioritize opportunities to leverage machine learning and particularly generative AI and agentic AI to drive decision making and automation across all levels of the R&D organization Translate business needs into clearly scoped machine learning projects, and take a hands-on approach to steer solution design and implementation Educate, demonstrate, guide, and enable the application of machine learning and particularly generative AI in various pharmaceutical R&D operations and scientific domains Identify, monitor, and validate relevant external AI/ML developments, cultivate relationships with external domain experts and partners, and report and present emerging novel developments within the organization to further innovation and shape long-term strategy and governance. Proactively build relationships across the company to inform your work and contribute to internal and external collaborations, through involvement in working groups, and the writing of insightful, engaging, and actionable opinion pieces that are easily digestible by internal decision makers and stakeholders. Be the leading voice for building common capability and approaches and for adopting best practices Work in collaboration with our Ethics and Governance teams to ensure our AI/ML applications are developed ethically and provide broad benefits to our patients and business Help talented, driven, enthusiastic AI/ML engineers and data scientists across the company grow professionally Measure, document, and communicate impacts of the Center's efforts E DUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: A track record of partnering cross-functionally with a wide range of stakeholders and cross-functional teams to develop and deploy novel data solutions in production environments Demonstrated passion for making complex technology more accessible and the ability to communicate complex technical topics simply and convincingly to a wide range of audiences Demonstrated ability in translating big picture business and product ideas into micro use cases and has a strong focus on solving core problems to deliver simple solutions Experience recognizing and communicating the implications of emerging technologies Excellent communication, prioritization, and interpersonal skills, with a high level of attention to detail An advanced degree (M.S., PhD.) in mathematics, applied statistics, computer science, machine learning or similar. With 8+ years of experience architecting, building, launching, and maintaining end-to-end ML systems from whiteboard to production at scale across a range of models and platforms, such as: Experience building agentic and LLM based solutions. Experience in fine tuning large language models for domain specific applications. Experience in designing transfer learning strategy to enable learning from small datasets. Demonstrated ability and authoritative knowledge in a variety of AI/ML problems and domains, with depth in at least two (computer vision, natural language processing, geometric deep learning, timeseries, reinforcement learning, multimodal learning, etc.). Solid understanding of deep learning model architectures (C/RNN, attention/memory, autoregressive, etc.) and extensions (Transformer, LSTM, Autoencoders, etc.) as well as traditional ML models (k-means, KNN, decision trees, SVM, Bayesian/graphical models, Gaussian process, etc.) and their real-world advantages and drawbacks. Experience tuning, validating, optimizing, visualizing, and debugging these models in applied settings. Familiarity with ML Ops concepts related to testing, retraining, and monitoring models in production. Experience in delivering custom software solutions for complex R&D needs, leveraging both internal and external resources. Expertise in implementing DevOps practices to drive efficient development-to-operations transitions and ensure automation across workflows. Experience in configuring and working in different coding environments (local, notebooks, containers) and using standard software engineering workflows (testing, code management/Git, CI/CD) An enthusiasm to ask questions and try and learn new things is essential Entrepreneurial experience is desirable. Experience in life sciences and healthcare and experience in a complex global organization is a plus 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: $174,500.00 - $274,230.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.

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 an innovative and dynamic AI/ML Research Senior Scientist with a passion for leveraging AI/ML in antibody discovery and design to join our Large Molecule AI/ML team. This role will be part of a multidisciplinary team focused on integrating advanced computational methods with cutting-edge experimental strategies to drive breakthrough discoveries in large molecule therapeutics and deepen our understanding of disease biology. The ideal candidate will have a strong background in computational biology, machine learning, and structural modeling and specifically with the application of AI/ML in biologics discovery. Key Responsibilities Develop and implement state-of-the-art AI/ML methodologies for de novo antibody design and discovery, including fine-tuning protein language models and generative protein design. Develop, implement, and deploy advanced machine learning algorithms for the multi-objective optimization of antibodies, antigens, ADCs, and other biologics . Build tools to incorporate data from integrated Design-Predict-Make-Confirm cycles with automated experimental platforms generating quality data at scale needed for project-specific and foundational models. Innovate, develop, and apply predictive models for protein design and developability engineering, utilizing large-scale NGS, in vitro, in vivo and other proprietary in-house and external data sources. Manage and process large-scale biological datasets for model training and evaluation Stay abreast of advancements in NLP, ML, and generative AI to build novel tools that enhance therapeutic discovery and development. Collaborate with internal experts to optimize the computational discovery infrastructure, offering both individual and team-based innovative solutions. Communicate complex scientific ideas effectively to both technical and non-technical audiences, fostering collaboration across multidisciplinary teams. Qualifications PhD degree in a scientific discipline (or equivalent) with 2+ years relevant experience, or MS with 8+ years relevant experience, or BS with 10+ years relevant experience Proven track record in developing machine learning models for chemical and biological data, including AI/ML-enabled molecular generation and affinity prediction. Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction. Proficiency in programming languages such as Python and experience with cloud computing capabilities. Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute individually and collaboratively. Versatile communicator who can elucidate complex ideas to non-specialists and commitment to continuous improvement and innovation. Demonstrated learning agility, and scientific curiosity while maintaining focus on driving greater impact in the face of uncertainty and change. Strong problem-solving aptitude and strategic thinking with an entrepreneurial mindset. Preferred Qualifications & Skills : Experience developing or applying modern ML architectures for antibody design models (LLMs, diffusion models, flow-matching, Bayesian Optimization, GNNs, etc.) Experience designing de novo binders for specified targets and epitopes Experience analyzing NGS-derived antibody repertoires for sequence- and structure-based design Experience with molecular simulation and conformational analysis techniques 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: $137,000.00 - $215,270.00 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. LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time Job Exempt YesIt 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.