Director, Clinical Outcomes Assessment, Global Evidence & Outcomes (Hiring Immediately)

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 As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the patient value of Takeda's new medicines to contribute to the successful development and commercialization of new, innovative therapies across the oncology portfolio through: ACCOUNTABILITIES: Conduct qualitative and quantitative research to inform development on conceptual disease-models. Develop, assess and interpret COAs, including Patient-Reported Outcomes (PROs), Observer-Reported Outcomes (ObsROs) and Clinician-Reported Outcomes (ClinROs), and performance outcome (PerfO) measures to derive clinical benefit during the clinical development and commercialization of new molecules, including development and validation of PRO and health-related quality of life instruments. Represent the GEO function on corporate cross-functional teams, providing strategic input related to product development and commercialization to enable and support informed decision making. Generate patient insights about disease and treatment, and lead the development of COA measurement strategies to support clinical development, post-authorization and commercial research activities across the lifecycle of drug development with consideration for global stakeholder needs. Lead strategy development and evidence generation of COA-based support tools for patients and healthcare professionals in routine clinical practice using digital technologies. Work within a multidisciplinary, matrixed organization to develop and execute successful Oncology COA endpoint strategies for multiple assets. Prepare and/or review outcomes research protocols, statistical analysis plans (SAPs), and reports, with a specific focus on COAs. Prepare, review, and publish scientific reports reflecting ongoing or completed work Collaborate and partner with key internal stakeholder colleagues to ensure priorities and strategies are aligned. Perform relevant research activities that may include, but not be limited to: Design, execution, and analysis in whole or in part of longitudinal prospective observational or randomized clinical trials evaluating clinical, and/or patient-centered endpoints; Targeted or comprehensive systematic literature reviews. Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, regulatory and reimbursement dossiers and other communication mechanisms. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Combination of academic training and practical experience (oncology experience preferred) in outcomes research is required. This may be consist of: Doctoral degree (e.g., Ph.D., Sc.D. or Dr.P.H.) in a relevant discipline such as, but not limited to, health services research, health outcomes research, epidemiology, pharmacy administration, public health, economics, statistics or decision sciences, plus 8 years practical experience Practical experience (number of years as noted above) in performing outcomes research, in any setting, including life sciences company, research organization, academic institution or governmental agency, is required. A minimum of 5 years of Patient Reported Outcomes experience is required. Demonstrated experience in interpreting statistical analysis is required. Ability to communicate scientific evidence, with strong written and verbal presentation skills, is required. Working knowledge of Patient Focused Drug Development (PFDD) Guidance documents and other relevant guidance documents and best practices is required. Ability to understand regulatory and HTA/payer challenges for Takeda products; and to critically review data and assimilate strategies that take such environments into consideration is required. Familiarity with the role and importance of outcomes research in the multi-disciplinary drug development and commercialization environment and process (involving multiple stakeholders) is required. Experience should include the conduct of outcomes research studies, and the communication of study findings to internal and external audiences. Expertise and experience with the development, psychometric evaluation and selection of PRO instruments used in clinical studies is expected. Must be capable of leading teams, influencing teams, and driving decisions; must also be able to work effectively as a member of different teams. Experience with the drug development process in the pharmaceutical industry is strongly preferred. Regulatory understanding and experience in negotiating PRO label claims is strongly preferred. Experience with ePRO is strongly preferred. Oncology experience is highly desirable Ability to work collaboratively and effectively in a multicultural and cross functional team environment. Experience managing budgets is expected. Demonstrated expertise in patient-reported outcomes/health-related quality of life assessment is highly desirable. Experience in conducting outcomes research in different geographic regions and interacting with regulator and/or HTA/payer policy-makers is highly desirable. 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for 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

ELECTRICIAN-ONSITE (Brewerton)

Description: Base Hourly : $20.00-$45.00/Hour Reports to – Production Manager Annual Bonus : No Direct Reports – None Remote: No Status – Non-Exempt Company Website: www.schneiderequip.com ABOUT SCHNEIDER At Schneider Packaging Equipment Company, Inc. (“Schneider”), we believe innovation starts with the consumer. This approach has propelled our success in developing real-world solutions that allow us to automate the supply of life’s products. With over 50 years of industry problem-solving in end-of-line automation, Schneider is a leading manufacturer of case packing and robotic palletizing solutions. Headquartered in Upstate New York, we design state-of-the-art machinery for customers in industries such as: food and beverage, dairy, pharmaceutical, personal care, plastics, and paper. Schneider is now a part of the Pacteon family of companies. Our continued growth has allowed us to really be our Customer’s one source for end of line packaging solutions. ABOUT PACTEON Pacteon Group provides one source for best-in-class automation focused on end of line packaging solutions, providing the highest-level customer experience. Through a broad range of robotic and non-robotic equipment, ability to integrate solutions seamlessly across portfolio companies, and full sales and service coverage, Pacteon is uniquely positioned to design flexible and custom solutions for your automation needs. For more information on Pacteon, please visit www.pacteon.com . OUR CORE VALUES We believe and live our Core Values, our IPACT: I ntegrity P ride A ccountability C ustomer Service T eamwork Our Pacteon Promise is “We make it right”. As our customer’s one source for end-of-line packaging solutions, everyone plays an important role to make that happen. We provide internal growth paths for our employees and support them in their professional development goals. Diversity is important to us; we are proudly an Equal Opportunity Employer striving for innovation and growth both for our employees and our Company. SUMMARY AND PURPOSE Plan and perform a variety of electrical assembly operations working from controls schematics / drawings and specifications following detailed instructions. KEY RESPONSIBILITIES · Plan and perform a variety of electrical assembly functions utilizing precision instruments, hand tools, work from controls drawings/schematics following documented procedures with general guidance. · Document changes to Controls drawings/schematics. · Perform I/O inspection functions following company policies and procedures. · Use hand tools and basic power tools such as drills, grinders, and bandsaws. · Collaborate with Assembly and Controls personnel to troubleshoot equipment. · Complete electronic labor reporting. · Assist other electricians in electrical assembly operations and procedures. · Contribute to the continuous improvement of the electrical assembly team and its functions. · Perform other related duties as required by management. · Potential travel with equipment for installation. Requirements: PROFESSIONAL QUALIFICATIONS · Education: o Three to five years’ experience in similar industry/custom machine-building manufacturing experience desired. o High School diploma or equivalent required. A.A.S. in electronics or electrical technology or advanced training in electrical technology. · Experience: o Ability to read schematics (AutoCAD Electrical preferred). o Familiarity with NEC/NFPA70E. · Skills: o Detail oriented and accurate. o Ability to operate computer (Microsoft Suite). o Ability to perform I/O inspections. BENEFITS · Medical/HSA/FSA · Dental · Vision · 401k · Company paid Life and AD&D · Optional Life Insurance · Flexible Work Schedule PHSICAL REQUIREMENTS & WORK REQUIREMENTS Physical Requirement Never Sometimes Frequently Sitting X Standing/Walking X Lifting/Carrying Upto 10 lbs X Lifting/Carrying Upto 30 lbs X Pushing/Pulling X Keyboarding X Gross Manipulation X Fine Manipulation X Driving X Stooping X Speaking X Hearing X Near Visual Acuity X Compensation details: 20-45 Hourly Wage PIf364202edc6d-38003-39073609

Director, Commissioning and Project Execution (Richmond)

Position Overview The Director, Commissioning & Project Execution, is a senior technical and program leadership role responsible for overseeing and executing commissioning programs for critical power infrastructure within the data center market. The role serves as the customer’s primary project and technical point of contact for commissioning and field service activities This role blends hands-on field expertise with program management, technical governance, and team leadership to ensure safe, reliable, and high-quality delivery of commissioning and other onsite services across factory and field environments The Director, Commissioning & Project Execution will lead a team of field service project managers with responsibility for team management and overseeing performance of the Field Service PM’s assigned projects – schedule, cost, and financial results The role also plays a key role in the standardization of processes, training, and continuous improvement services initiatives across the Forgent portfolio, which is critical to scaling the business. The position is initially focused on the physical support of the Richmond data center market with travel to other large data center project locations over time Program & Field Execution • Manage and execute remote and onsite commissioning programs while remaining actively engaged in both manufacturing and deployment environments. • Provide hands-on technical support during equipment commissioning, testing, electrical tie-ins, system energization, and troubleshooting activities. • Support onsite commissioning activities as required to meet customer schedules, contractual commitments, and operational milestones. • Serve as a technical resource to Project Managers, ensuring alignment between project execution, commissioning scope, and customer expectations. • Provide on-call technical support to respond to critical issues and deliver timely guidance outside of normal business hours when required Technical Leadership & Escalation • Act as the primary technical escalation point for field service and commissioning teams. • Support troubleshooting on complex electrical and controls systems, lead repairs, and guide resolution of critical power system issues. • Perform root cause analysis of equipment or system failures and drive corrective and preventive actions. • Partner with vendors and OEMs for equipment validation, installation support, and advanced troubleshooting. Commissioning Standards & Documentation • Develop, review, approve, and maintain commissioning procedures, work instructions, and test protocols for both factory and field activities. • Prepare project commissioning test scripts for designated equipment and scopes of work. • Assist with the development & refinement of factory testing standards and acceptance criteria. • Attend factory testing of equipment scheduled for deployment and provide structured feedback to engineering and quality teams. • Develop and maintain standardized commissioning templates for all electrical equipment within the Forgent portfolio. • Ensure commissioning procedures and results support safe operations, regulatory compliance, and customer requirements. Reporting & Tools • Track commissioning activities across assigned projects and prepare comprehensive commissioning reports and closeout packages. • Utilize commissioning and testing software platforms such as CxAlloy, PowerDB, or equivalent tools to support commissioning activities and documentation. • Participate in regular commissioning (Cx) meetings for assigned projects and provide status updates, risk identification, and mitigation plans. Cross-Functional Coordination • Coordinate closely with product engineering, quality, manufacturing, operations, and field service teams to ensure seamless execution. • Interface with general contractors, subcontractors, owner’s representatives, and other onsite stakeholders during commissioning activities. • Provide a structured feedback loop to engineering and manufacturing teams to drive continuous improvement in equipment quality, testing procedures, and field performance. Coaching, Mentoring & Services Project Leadership • Lead, train, and mentor a team of field service project managers fostering a culture of technical excellence, accountability, and safety. • Accountable for performance management of field service project management team · Develop and oversee training programs to enhance technical competency, safety awareness, and professional growth of field service project management teams. • Identify training & certification opportunities for field service project managers. • Identify needs for additional field service project managers and develop business cases to support hiring and resource expansion. Services Project Oversight & Financial Management • Provide overall oversight of assigned services projects, ensuring execution on schedule, within approved budgets, and aligned with contractual scope. · Lead and support Field Service Project Managers in developing and maintaining detailed project plans, resource forecasts, and risk mitigation strategies. · Establish and enforce project controls for schedule adherence, cost management, change control, and margin protection across all services engagements. · Partner closely with Finance to ensure accurate percent-complete revenue recognition, including timely updates to project cost-to-complete, earned revenue, and forecasted margins. · Support services project forecasting, backlog reporting, and financial review cycles, providing clear visibility to leadership on performance, risks, and corrective actions. · Ensure consistent and timely project status, financial, and performance reporting to internal stakeholders and executive leadership. Required Qualifications • Minimum 12 years of mission critical infrastructure experience, including at least 6 years supporting data center environments. • Minimum 5 years of hands-on electrical testing and commissioning experience in critical power environments. • Four-year ABET-accredited degree in Engineering or Engineering Technology (Electrical or Mechanical preferred). • Demonstrated experience commissioning medium- and low-voltage power systems including switchgear, UPS systems, generators, and associated controls. • Strong understanding of safety practices including lock-out/tag-out (LOTO), arc flash mitigation, and commissioning best practices. • Ability to lead teams, mentor technical staff, and manage multiple commissioning efforts concurrently. • Strong communication skills with the ability to interface effectively with customers, contractors, vendors, and internal teams. Preferred Qualifications • Professional Engineer (PE) licensure in Electrical or Mechanical Engineering. • Project Management Professional (PMP) certification. • Hyperscale, AI, or high-performance computing (HPC) data center construction, commissioning, and operations experience. • Prior experience serving as a Commissioning Agent (CxA) or lead commissioning engineer. • Familiarity with IEEE, NFPA, NETA, UL, and IEC standards. • Experience with commissioning platforms such as CxAlloy, PowerDB, or equivalent tools. Work Environment • Regular onsite presence with periods of working remote • Combination of office, factory, and active construction site environments. • Initial travel requirements are limited with focus on the Richmond VA area, but will increase over time to support large projects in other areas LI-EC1 PIed8c7a8db0bb-38003-40499932

Audiologist (CCC-A) (Valhalla)

AUDIOLOGIST (CCC-A) Valhalla, NY About the Audiologist Position: The Speech & Hearing Center in Valhalla, NY is searching for a dedicated and compassionate part-time Audiologist to join our team of healthcare professionals. As an Audiologist, you will be responsible for evaluating and diagnosing auditory disorders, recommending and providing appropriate treatments, and offering rehabilitative services to patients experiencing hearing loss or other hearing-related issues. About the WIHD's Speech & Hearing Center: The Speech and Hearing Center works in collaboration with Westchester Medical Center, the CI Balancing Center and APS, and is a major resource for audiology in Westchester and the Lower Hudson Valley. We provide the range of diagnostic and rehabilitative services including, diagnostic audiology, electrophysiologic measures (ABR & OAE), auditory processing testing, hearing aids and bone conduction devices. Services are provided to infants, children, and adults, some of whom have neurodevelopmental disabilities. WIHD provides a positive working environment that promotes employee safety, growth and goal attainment. We offer a setting with a desirable work-life balance and flexible schedule. The ideal candidate will possess experience providing the audiology services across the age range. Preference will be given to individuals who have a desire to work with children and/or those with neurodevelopmental disabilities. Some supervision of graduate students may be necessary. Audiologist Qualifications: Master’s or Doctoral degree in Audiology from an accredited institution.NY State licensure or eligibility to obtain licensure as an Audiologist.Certificate of Clinical Competence in Audiology (CCC-A) from the American Speech-Language-Hearing Association (ASHA) or equivalent certification.Strong knowledge of audiological diagnostic procedures, assessment techniques, and treatment options.Proficient in using sophisticated audiological equipment and specialized software for testing and analysis.Excellent communication skills, both verbal and written, with the ability to explain complex audiological concepts to patients of all ages.Empathetic and patient-focused approach to address the emotional and psychological aspects of hearing loss.Detail-oriented with exceptional organizational and time management skills. Benefits: Paid Sick 403 (b) Employee assistance programParental leaveReferral program Why Work at WIHD? Positive, inclusive work environment Flexible schedules for work-life balance Mission-driven organization serving 10,000 individuals annually Equal Opportunity Employer WIHD is committed to fostering a workplace culture that values respect, fairness, and equal opportunity. Employment decisions are based on individual qualifications, experience, and business needs. We comply with all applicable laws and do not discriminate on the basis of race, color, national origin, citizenship status, religion, age, sex, marital status, sexual orientation, gender identity, disability, veteran status, pregnancy, or any other status protected by law. Compensation details: 55 Hourly Wage PId6c7620d4015-38003-40546762

Global Therapeutic Research Lead - Immunology (Hiring Immediately)

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. 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 , or MS 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: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement

Director, Global Regulatory Labeling Strategy (Hiring Immediately)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. 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

Director, Regulatory Site CMC (Hiring Immediately)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director 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: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for 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.

Associate Director, Statistics (Hiring Immediately)

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 Associate Director, Statistics in our Cambridge, MA 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. POSITION OBJECTIVES: Takeda’s mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R&D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda’s R&D pipeline. Central to Takeda’s R&D operating model are the pillars of Data & Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R&D growth and strengthens competitiveness. R&D Data & Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics & Quantitative Sciences, Programming, Patient Safety & Pharmacovigilance, and Strategic Operations The Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. POSITION ACCOUNTABILITIES: Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PHD with ~ 5 years experience MS with ~ 8 years experience Technical Skills: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R&D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D Create an internal and external sphere of influence in area of expertise This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 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: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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.

Director, Global Regulatory Affairs CMC (Hiring Immediately)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) and may serve as the GRA CMC Product Lead, as required. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Acts as mentor / coach to other GRA CMC members. How you will contribute: Develops, executes and oversees the preparation of major global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters. Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Providing strategic input into change control evaluation - as required. As a GRA CMC member, ensures and / or enhances regulatory compliance. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Proactively identifies regulatory CMC risks, ensuring timely communication with line management. Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target. Supports development of strategies, tools, and trainings to further the GRA CMC roadmap. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required. 10 years of overall biopharmaceutical/device industry experience with 8 years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Applies direction taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) pl

Associate Director, Quantitative Clinical Pharmacology (QCP) Lead (Hiring Immediately)

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 Associate Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA 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. POSITION OBJECTIVES: Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Our Data and Quantitative Sciences group (DQS) is made up of more than 500 quantitative scientists who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation. As part of DQS, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team. The QCP role works in partnership with the pharmacometrics lead to drive a MIDD path within each project. Leads strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management. Possesses primary responsibility for dosage selection and generation of causality evidence. Provides additional portfolio support through program reviews, collaborative decision-making, infrastructure and best practice initiatives. Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines. Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications. POSITION ACCOUNTABILITIES: Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated scientific and operational sub-teams. Be charged with integrating pharmacokinetic, pharmacodynamic, efficacy and safety data from multiple sources to optimize dosing for different populations across the development continuum. Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK). Enables impactful Model-Informed Drug Development (MIDD) practices and advanced modeling and simulation approaches (e.g., QSP, MBMA) to inform internal decisions and external regulatory interactions. Represents Clinical Pharmacology in meetings with global or regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions. Oversees and/or independently performs PK, PD, and pharmacometric analyses including the interpretation of PK/PD data in close partnership with DSI and external partners. Maintains a high standard for good clinical practice, compliance, and ethics. Mentors junior staff to promote scientific excellence and individual achievement. Participates as a member of Business Development due diligence, when requested. Contributes to infrastructure initiatives and/ or cross-functional best practice initiatives. Has scientific influence outside QCP and Takeda through presentations and publications and active contribution to scientific societies and cross-industry consortiums related to the clinical pharmacology discipline such as ACCP, ASCPT, ACOP, PAGE, ISQP, IQ, and DIA. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Pharm D. or PhD with 5 years of working experience in a quantitative field with some exposure to clinical pharmacology /PK-PD MS with 8 years' working experience in a quantitative field with some exposure to clinical pharmacology/PK-PD Technical Skills: Advanced knowledge and experience in clinical pharmacology responsibilities in early & late stage and post-marketing studies. Formulates and executes clinical pharmacology plans including integration of MIDD principles. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs. Advanced knowledge of regulatory guidance for industry applicable to the design, analysis of clinical trials and process for regulatory submissions across different regions (ICH, FDA, EMA and others). Advanced knowledge and/or hands-on applications in integration of PK, PD, efficacy, and safety data from multiple sources for dose selection and decision-making. Subject matter expertise in several clinical pharmacology areas and establishes oneself as a go-to colleague on a few topics. Scientific understanding of biological translation, drug development and its integration into the clinical pharmacology/pharmacometrics strategy. This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 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: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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 creat

Associate Director, Global Regulatory Affairs CMC (Hiring Immediately)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: 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. 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: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in 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.

Senior Director, Global Regulatory Lead – Oncology (Hiring Immediately)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs. How you will contribute: Lead global regulatory strategy for assigned programs across development stages. Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients Will be responsible for complex and potentially multiple projects within the Oncology TAU. Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives. Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise. Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products. When necessary, seeks expert advice and technical support from functional stakeholders and senior management. Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members. Ensures alignment of global regulatory strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management. Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary FDA point of contact for projects of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. May oversee execution. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). Minimum Requirements/Qualifications: BSc/BA Degree, scientific discipline strongly preferred. Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 12 years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8 years regulatory and/or related experience. Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive,