By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R Read Less

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 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 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

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 Role 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 establish and monitor achievement of success criteria and milestones. Platform, Data 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 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 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R 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 Read Less

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 Senior Medical Director, Solid Tumor in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R Read Less

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

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

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 DescriptionObjective / 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 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 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 SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$174,500.00 - $274,230.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R 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 - $241,340.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medic Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R Read Less

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 Read Less

Position: OB Hospitalist - Full-Time/Part-time/PRN Hospital: Saint Vincent Hospital Location: Worcester, Massachusetts About Saint Vincent Hospital: Saint Vincent Hospital has over 2,000 births a year. Saint Vincent Hospital's Center for Women and Infants offers 10 warm and comfortable Labor and Delivery rooms. The environment is welcoming and the rooms are equipped with the latest technological innovations used in state-of-the-art childbirth centers (including wireless fetal monitoring). The hospital offers a Level II NICU for special care for premature babies and a dedicated obstetrical anesthesia staff available around the clock. This Full-Time Hospitalist Position Offers: Flexible schedules No on-call responsibility CME allowance and 401k Leadership training and career advancement opportunities Paid medical malpractice insurance with tail Paid parental leave Full medical benefits including dental and vision Collegial, team-based work environment Ongoing professional training and development Volunteer opportunities for group medical mission trips Awards and recognitions Engagement opportunities Health wellness benefits What Does an OB/GYN Hospitalist Do? Caring for all pregnant women who present emergently, regardless of circumstance Cultivating relationships with staff nurses and hospital personnel Supporting private practice physicians by providing coverage and assistance Caring for unassigned patients Evaluating and treating triage patients Providing consultation to the ED Monitoring labor and Delivering babies Performing surgery and surgical assists Evaluating and treating postpartum patients Assisting with OB residents and medical student education Providing nurse support and education Participating in emergency drills and simulations Developing best practices Participating in clinical trials Facilitating daily interdisciplinary board rounds to improve patient safety If interested in learning more, please contact Lauren Rexroad at (864) ###-####, or email ...@obhg.com. Read Less

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 Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. 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: Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s): Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. The assigned clinical studies may be of low to medium level of complexity. More than one study and/or more than one program may be assigned. ACCOUNTABILITIES: Accountable for planning and operational strategy and execution for assigned clinical trials. You can get further details about the nature of this opening, and what is expected from applicants, by reading the below. o Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. o Challenges study team to ensure operational feasibility, inclusive of patient and site burden. o Validates budget and ensures impacts are adequately addressed. o Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy. o Challenges study team to ensure timelines meet the needs of the clinical development plan. o Ensure new team members and vendors are appropriately onboarded. During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place. Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly. Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs. Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted. Specific areas of sponsor oversight include, but are not limited to: o Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring. o Review and endorsement of relevant study plans, as applicable. o Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes. o Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study. o Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies. In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections. EDUCATION AND EXPERIENCE: BS/BA required, preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience. Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements. 5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years clinical study management/oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous. Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated successful experience in project/program management and matrix leadership. Good communication skills. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). 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: $99,500.00 - $156,420.00 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. xuwmhxw U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Job Exempt Yes Read Less

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. Find out if this opportunity is a good fit by reading all of the information that follows below. 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. Purpose Leveraging a proven track record of leading at least 3 discovery programs to clinic, The Global Therapeutic Research Lead (GTRL) is a pipeline critical strategic leader responsible for driving Research projects to the clinic. The individual will sit on the Gastroenterology and Inflammation Drug Discovery Unit (GI DDU) Leadership Team. Leader for at least one or more of Takeda's top priority projects with substantial clinical and commercial potential with a clear accelerated path to the clinic. You will provide mentorship to team members to elevate enterprise thinking and capabilities of our drug discovery talent across the global Research function. As project lead, the GTRL builds a connected view of the project within the Gastroenterology and Inflammation TA strategy and treatment paradigm and can represent all core expertise at depth and align with stakeholders and sponsors across the organization including Research, Clinical Development and Commercial stakeholders and executive level governance committees. The GTRL will be responsible for creating the medicine vision, early asset strategy and managing multiple external partnerships that accelerate delivery of the project. The GTRL will establish smart, fast, and critical path minded practices for groups, including integrating new strategies and competitive industry ways of working. The GTRL will advise on the continuous infusion of new Research projects aligned to strategy to generate a sustainable Research Engine generating a steady flow of high-quality INDs every year. Accountabilities Lead and manage one or more 'Top 10' drug discovery projects, overseeing the entire drug discovery process from target identification to preclinical development. (Top 10 projects are well validated targets that are focused on strategically aligned modalities with substantial clinical and commercial potential) Responsible for the articulation and ownership of the project strategy, developed in partnership with internal stakeholders. Contribute to strategy for future portfolio investment, particularly within the Inflammation and Immunology area including advising on which projects should be Top 10 projects. Evaluate and prioritize potential drug candidates based on scientific, medical, and commercial considerations. Represent all core expertise for the project. Partner with Clinical and Translational teams to refine asset strategy. Ensure alignment to the therapeutic area strategy (i.e., Clinical Development). Understand and align with the commercial team for asset commercial value within the TA. Provide guidance and mentorship to global project team members, stimulating enterprise thinking and fostering their professional growth and development. Mentor future and more junior project leads and elevate drug discovery capability across Research. Collaborate with cross-functional teams and partners (e.g., DMPK, Pharmaceutical Sciences) within and outside Takeda to drive project delivery. Pipeline and enterprise impact through effective partnering with multiple internal and external collaborators. Provide strategic, process, and operational leadership for successful Top 10 Project delivery. Foster a culture of innovation and scientific excellence within the matrixed drug discovery team, promoting collaboration, knowledge sharing, and continuous learning. Become a world leading scientific expert in the projects you lead. Oversee the design and execution of experiments, data analysis, and interpretation to enable decision-making and optimize drug discovery efforts. Stay abreast of the latest advancements in drug discovery, emerging technologies, and industry trends, applying this knowledge to enhance drug discovery strategies. Build and maintain relationships with key stakeholders, including academic institutions, research organizations, and industry partners inclusive of serving on joint external governance committees across the globe. Represent Takeda externally for the Gastroenterology and Inflammation Drug Discovery Unit and play a key role in evaluating external opportunities, serving as an effective ambassador for Takeda's global business development brand. Education Competencies (Technical and Behavioral): PhD degree in a scientific discipline with 15+ years experience , orMS with 21+ years experience, or BS with 23+ years experience Expected to have at least 10-12 years industry and relevant subject matter expertise within Immunology and Inflammation and at least 10-12 years global management experience, including working effectively with matrix teams. Extensive experience in leading drug discovery teams and managing drug discovery/development projects, preferably in a pharmaceutical or biotechnology setting covering gastroenterology and inflammation. Deep understanding of the drug discovery process, including target identification, hit-to-lead optimization, and preclinical development, anticipating, and removing roadblocks. Proven track record of leading numerous projects, ideally 5+ projects, across discovery from target inception to Candidate Nomination or beyond. Played a major role in 3+ INDs. Has delivered clinical development assets, must include experience with biologics and preferably across multiple modalities. Excellent and inclusive leadership with the ability to inspire and motivate diverse teams towards achieving ambitious goals. Reputation as a proactive, solutions-oriented leader who engages relevant expertise no matter where it resides. Strong business acumen and understanding of the pharmaceutical industry, including regulatory requirements and commercial considerations with relevant knowledge and expertise for specific modalities. Exceptional communication and presentation skills, with the ability to effectively communicate complex scientific concepts to diverse audiences. Proven ability to build and maintain collaborative relationships with internal and external stakeholders across a matrixed organization. Strong problem-solving and decision-making abilities, with a focus on data-driven decision making. Demonstrated success in building and managing strategic partnerships with academic institutions, research organizations, and industry collaborators. 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: $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. xuwmhxw 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 Read Less

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. If your skills, experience, and qualifications match those in this job overview, do not delay your application. 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. xuwmhxw 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 Read Less

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. Do not wait to apply after reading this description a high application volume is expected for this opportunity. 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. xuwmhxw U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Read Less

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. While professional experience and qualifications are key for this role, make sure to check you have the preferable soft skills before applying if required. 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. xuwmhxw 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. Read Less

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. Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply. Job Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. Promote sustainable practices and scalability in site-level regulatory operations. 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 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US. 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. Proven ability to develop global regulatory strategy recommendations based 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. Understands who is responsible for different decisions and escalates as necessary. Applies directions 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. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. xuwmhxw An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

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. Any additional information you require for this job can be found in the below text Make sure to read thoroughly, then apply. 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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. xuwmhxw An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

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 Manager, Feasibility based remotely reporting to the Director, Feasibility. At Takeda, we are transforming the pharmaceutical industry through our R in life science (preferred). At least 4 years of direct responsibility in leading strategic feasibility assessments or equivalent data analytics role(s) in a healthcare or clinical research setting at a sponsor or CRO. 6+ years of experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor. Direct experience in the pharmaceutical industry or related field. Experience with leading edge trial optimization vendors, tools and methods. Proficiency with software models and database structures. Expertise in principles driving country/site identification, feasibility and study startup strategies. 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: $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. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #LI-Remote Read Less