Construction

Senior Manager, Global Regulatory Affairs CMC

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: This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With some supervision, 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 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 foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from 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. How you will contribute: With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s) Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges. With supervision, supports 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 with some supervision. As a RA 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. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree preferred. 6 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. 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 some 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: $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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Lead Clinical Study Manager

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 Lead 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 high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. 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. Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. Challenges study team to ensure operational feasibility, inclusive of patient and site burden Validates budget and ensures impacts are adequately addressed. 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. Challenges study team to ensure timelines meet the needs of the clinical development plan. 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: Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring Review and endorsement of relevant study plans, as applicable Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes 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 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 time; may be involved in regulatory inspections by preparing for and/or attending the inspections. Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior CSMs. May assist the program COPL in his/her role, as required 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. 6 years’ experience in pharmaceutical industry and/or clinical research organization, including 4 years clinical study management/oversight. Experience must 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 excellence in project/program management and matrix leadership. Excellent communication skills. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. 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: $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. LI-Remote

  • Boston, MA

  • no content

Manager, Statistics

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 Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity: JOB LOCATION: Cambridge, MA POSITION : Manager, Statistics POSITION DESCRIPTION : Takeda Development Center Americas, Inc. is seeking a Manager, Statistics with the following duties: Provide statistical support in the design, analysis, and interpretation of clinical trials to enable quantitative decision making at a compound level for Takeda programs; independently represent statistics function on global teams in support of drug development; develop and review the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables; leverage internal and external resources to achieve quality, timely and cost-effective compound level and submission deliverables; plan and direct compound level analysis and reporting activities including work of other statisticians and programmers; monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analysis methods, and implement innovative approaches at a compound level. Up to 100% remote work allowed from anywhere in the U.S. The estimated salary range reflects an anticipated range for this position. 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. REQUIREMENTS: Ph.D. degree in Mathematics, Biostatistics, Statistics or related field. Prior experience must include: Familiarize with innovative clinical study designs, complex analytical methods, and inferential statistics and be able to conduct mathematical and statistical simulations based on those advanced methodologies to support clinical trials; Apply advanced knowledge and leverage hands-on experience on data analyses utilizing mathematical and statistical programming software and languages (such as SAS, R, MATLAB, etc.) to facilitate drug development processes in pharmaceutical industry; Demonstrate extensive knowledge of FDA and ICH regulations and industry standards applicable to the design, conduct and analysis of clinical trials, and regulatory submissions; Provide oversight of statistical activities (such as SDTM/ADaM standards, TFLs, etc.) to ensure timeline and quality of analysis data and statistical outputs. Full time. $137,000 - $234,800 per year. Qualified applicants can apply at https://jobs.takeda.com . Please reference job R0174374 . EOE Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

  • Cambridgeport, MA

  • no content

Research Senior Scientist, AI/ML (Biologics)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. The AI/ML organization at Takeda is building a team to transform how medicines are discovered. Our goal is to apply AI and machine learning across the entire drug discovery process, not just isolated steps, but as an integrated approach from target identification through development. This requires discernment: knowing which models and methods fit each problem, and the creativity to adapt when they don't. We work with foundational models, generative approaches, and autonomous systems, but the tools only matter when paired with people who understand the science deeply enough to use them well. Our team brings together computational scientists, biologists, engineers, and drug hunters. If you want to contribute your expertise to hard problems alongside colleagues with different perspectives, and help shape how AI delivers real impact in drug discovery, we'd like to hear from you. Position Overview We are seeking an innovative and dynamic AI/ML Research Senior Scientist with a passion for leveraging AI/ML in antibody discovery and design to join our Large Molecule AI/ML team. This role will be part of a multidisciplinary team focused on integrating advanced computational methods with cutting-edge experimental strategies to drive breakthrough discoveries in large molecule therapeutics and deepen our understanding of disease biology. The ideal candidate will have a strong background in computational biology, machine learning, and structural modeling and specifically with the application of AI/ML in biologics discovery. Key Responsibilities Develop and implement state-of-the-art AI/ML methodologies for de novo antibody design and discovery, including fine-tuning protein language models and generative protein design. Develop, implement, and deploy advanced machine learning algorithms for the multi-objective optimization of antibodies, antigens, ADCs, and other biologics . Build tools to incorporate data from integrated Design-Predict-Make-Confirm cycles with automated experimental platforms generating quality data at scale needed for project-specific and foundational models. Innovate, develop, and apply predictive models for protein design and developability engineering, utilizing large-scale NGS, in vitro, in vivo and other proprietary in-house and external data sources. Manage and process large-scale biological datasets for model training and evaluation Stay abreast of advancements in NLP, ML, and generative AI to build novel tools that enhance therapeutic discovery and development. Collaborate with internal experts to optimize the computational discovery infrastructure, offering both individual and team-based innovative solutions. Communicate complex scientific ideas effectively to both technical and non-technical audiences, fostering collaboration across multidisciplinary teams. Qualifications PhD degree in a scientific discipline (or equivalent) with 2 years relevant experience, or MS with 8 years relevant experience, or BS with 10 years relevant experience Proven track record in developing machine learning models for chemical and biological data, including AI/ML-enabled molecular generation and affinity prediction. Demonstrated experience in modeling antibody/ antigen sequence, structure and interaction. Proficiency in programming languages such as Python and experience with cloud computing capabilities. Strong analytical and problem-solving skills, with demonstrated creativity and the ability to contribute individually and collaboratively. Versatile communicator who can elucidate complex ideas to non-specialists and commitment to continuous improvement and innovation. Demonstrated learning agility, and scientific curiosity while maintaining focus on driving greater impact in the face of uncertainty and change. Strong problem-solving aptitude and strategic thinking with an entrepreneurial mindset. Preferred Qualifications & Skills : Experience developing or applying modern ML architectures for antibody design models (LLMs, diffusion models, flow-matching, Bayesian Optimization, GNNs, etc.) Experience designing de novo binders for specified targets and epitopes Experience analyzing NGS-derived antibody repertoires for sequence- and structure-based design Experience with molecular simulation and conformational analysis techniques ADDITIONAL INFORMATION The position will be based in Cambridge, MA Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Director, Head of High-Throughput in vitro ADME

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Objective / Purpose: The Director, High-Throughput In Vitro ADME is a senior scientific and operational leader responsible for building and directing Takeda’s high-throughput in vitro ADME capabilities in support of small- and large-molecule discovery programs. Reporting to the Head of Drug Discovery Lab Automation and Transformation, this Director will define strategy, oversee operations, and drive technology innovation at the interface of ADME science, laboratory automation, and robotics. The organization will operate as a service-oriented group, delivering robust, high-quality ADME data to enable rapid, high-confidence decision-making in Design–Make–Test–Analyze (DMTA) cycles across the portfolio. Accountabilities: Strategic Leadership & Vision Define and execute the multi-year strategic roadmap for high-throughput in vitro ADME at Takeda, aligned with the broader vision of the Drug Discovery Lab Automation and Transformation organization. Shape an enterprise-level, service-oriented operating model for ADME, ensuring capacity, capability, and flexibility to meet evolving project and portfolio needs. Champion innovation in high throughput assay design, detection technologies, automation, and data workflows to enhance throughput, quality, and cost-effectiveness. Team Leadership & People Development Lead, mentor, and grow a team of scientists and research associates responsible for the routine delivery of a comprehensive suite of in vitro ADME assays. Build a culture of scientific rigor, operational excellence, safety, and customer focus, supported by clear KPIs (e.g., cycle time, success rate, capacity utilization, cost-per-data point). Drive talent development and performance management appropriate for a Director-level organization. High-Throughput ADME Operations Oversee design, execution, and continuous improvement of a broad high throughout in vitro ADME panel, including but not limited to: Metabolic stability and clearance (microsomes, hepatocytes, S9) CYP inhibition and induction Permeability (e.g., Caco-2, MDCK, PAMPA) Plasma protein and tissue binding Transporter and other mechanistic assays Ensure robust support for both small-molecule and large-molecule modalities, adapting methods for new modalities and platforms as the portfolio evolves. Own and maintain fit-for-purpose validation, QC, and SOP frameworks, including root-cause analysis and corrective actions for assay or system deviations. Laboratory Automation, Robotics & Miniaturization Provide scientific and strategic leadership for laboratory automation and robotics within the in vitro ADME space, in close alignment with the Head of Drug Discovery Lab Automation and Transformation. Lead assay miniaturization up to 1536-well formats, from feasibility and optimization through technology transfer into robust, routine operation. Oversee integration of liquid handlers, plate handlers, robotic arms, incubators, readers, and scheduling software into end-to-end automated workflows. Partner with internal automation/engineering and informatics teams to ensure seamless connectivity between instruments, LIMS/ELN, data pipelines, and analytical platforms. Cross-Functional Collaboration Serve as the primary ADME service leader interfacing with DMPK, medicinal chemistry, biology, pharmacology, translational sciences, and data science. Translate portfolio and project needs into clear ADME assay strategies, capacity plans, and timelines; communicate priorities, risks, and trade-offs with transparency at project and governance levels. Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities. Quality, Compliance & Continuous Improvement Ensure scientific quality, data integrity, and safety in all ADME operations, consistent with Takeda policies and relevant regulatory expectations. Define and monitor KPIs for throughput, on-time delivery, reproducibility, and cost; apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement. Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues. Education and Experience: Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10 years of relevant industry experience; or M.S. with 16 years; or B.S. with 18 years in pharmaceutical/biotech R&D. Extensive expertise in in vitro ADME, including method development, validation, and deployment across core assay types. Direct experience in an organization providing ADME services (e.g., CRO or internal ADME service group), with a strong service- and customer-oriented mindset. Proven leadership experience at the Director level, managing scientific teams and complex operations in a high-throughput environment. Demonstrated strategic and hands-on experience with laboratory automation and robotics, including selection, implementation, and lifecycle managemet. Successful track record in miniaturizing ADME assays formats, including optimization for data quality, robustness, and throughput. Experience supporting both small- and large-molecule discovery programs. Familiarity with LIMS/ELN, instrument integration, and data analysis/visualization tools in a high-throughput setting. Proven track record of: Building or transforming high throughput ADME capabilities (e.g. establishing new platforms, scaling capacity, modernizing legacy workflows. Understanding how ADME outputs integrate with DMPK, PK/PD and translational strategies and inform decision making Experience with data science and process optimization approaches to support advanced analytics, and continuous improvement ADDITIONAL INFORMATION The position will be based in Cambridge, MA . This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Senior Manager, Statistics (Oncology)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objectives: Takeda is a global, values-based, R&D-driven, top 15 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) 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 Statistics and Quantitative Sciences (SQS) at Takeda is looking to add individuals to our team that are team oriented, collaborative, strong understanding of the statistics function, exceptional leaders and innovators. SQS aspires to bring safe and effective medications to the patients with our quantitative skills. We design efficient trials, contribute to clinical development strategies, perform high quality statistical analyses, and pursue operational excellence. About the role: This Senior Manager, Statistics is responsible for providing statistical support in clinical development related to diseases and assets within the Neuroscience Therapeutic Area. This role involves independently managing projects, providing innovative solutions to problems, leading data strategy development. This role contributes to Takeda’s mission. Delivery and Business Accountabilities: Lead and be accountable for study/program level delivery Effectively drive and influence project teams towards seamless delivery while enabling and making decisions Conduct advanced statistical analyses and perform trial simulations to provide innovative solutions and to optimize clinical trial designs. Implement a quantitative decision making framework to support data-driven decisions in clinical development Participate in preparation of regulatory submissions and responses to regulatory agencies. Contribute to asset level strategies to identify and mitigate delivery risks. A Senior Manager, Statistics, through her/his daily work, should have impact on: Global project sub-teams (e.g., Evidence Generation) Broadly DQS functions Parts R&D functions Core Skill and Qualification Elements: Advanced knowledge of drug development, clinical study designs, trial simulations, analysis methodology and data interpretation. Advanced knowledge of pharmaceutical industry, overall drug development process and expertise in the cross-functional interfaces with the statistics function. Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions. Strong statistical programming skills (SAS and R) Excellent oral and written communications skills. Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases (Experience in Neuroscience preferred). Strong project management skills. Strong collaborative skills and ability to work with a cross-functional team to achieve project objectives. Technical/Functional Expertise: A Senior Manager, Statistics needs to demonstrate: The capability to gain broader technical expertise outside of primary area The ability to communicate effectively with cross functional teams and explain statistical and quantitative concepts to non-experts The drive for learning techniques and methods and also for continuous improvement through various avenues of the organization Leadership: A Senior Manager, Statistics may have to: Lead projects directly or indirectly related to Global Program Teams (GPTs) or other functions Work independently and prioritize projects Effectively drive and influence project teams towards objectives while enabling and making decisions Contribute to asset level strategies Have internal and external presence on topics of interest Educations: Applicants for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PhD with approximately 3 years of experience. MS with approximately 6 years of experience. Behavioral Competencies: An ideal candidate for this position should: Be able to make decisions Initiate and foster collaborative relationships Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $137,000.00 - $215,270.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Maintenance Mechanic II

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Maintenance Mechanic II will perform the maintenance, preventive, and corrective maintenance of the production manufacturing equipment in the Los Angeles M anufacturing Plant . Prepare detailed documented work orders. Shift Details: Swing Shift ( Monday-Friday 2:00pm-10:30pm) How you will contribute: Performs preventive maintenance and corrective maintenance of critical plant equipment on a regular basis, to include, but not limited to: Production Equipment, Critical Systems, Sterilization Equipment and electrical control systems as responsibility assigned to Manufacturing Maintenance in both cGMP and non-cGMP areas. Requires familiarity with generally accepted building, plumbing, piping, electrical, and fire protection practices and codes to include National Electrical Code (NFPA-70 and NEC) Uniform Building Code (UBC) in compliance with L. A. City, Takeda EH&S and Factory Mutual requirements. Must follow safety rules and ensure compliance with L.A. City, CA state and federal EPA regulations and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulation agencies to include but not limited to L.A. City Building and Safety, SCAQMDM, L.A. City Bureau of Sanitation, and CAL OSHA. Ability to verify mechanical and electrical drawings for accuracy. Perform SOP job plans, and drawing redlines as necessary. Ability to provide a moderate level of troubleshooting, diagnostic, and repair of production equipment and production equipment components which may include but not limited to process control systems, mixers, centrifuges, pumps, piping, plumbing components, and automated manufacturing systems. Requires familiarity with generally accepted building and electrical codes to include NEC and UMC in compliance with LA City and Takeda EH&S. Support engineering projects including but not limited to equipment installation, commissioning, and validation process. Follow and comply with EPA, OSHA, and NFPA regulations and with SOPs and cGMP policies. Attend required training and meetings. Performing Disposal of Hazardous Waste May perform other duties as assigned. What you bring to Takeda: High school diploma or GED 2 years of experience or AA or higher and 1 years of related work experience. Skilled craft training/apprenticeship certificate or commensurate combination of technical education and experience. 2 year technical/ A.A./A.S. technical discipline or Journeyman skilled craft training/apprenticeship certificate or commensurate combination of technical education and experience is highly desirable Must have knowledge of manufacturing equipment including distribution, filtration systems, centrifuges, sterilization, autoclaves, process tanks, incubators and CIP/COP systems, PLC based process control systems, Human Machine Interface (HMI) configuration. Knowledge of Delta V and CMMS systems such as JDE and RAM. Knowledge of basic chemical and biological safety procedures. Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Must have knowledge in Lock out/Tag out (LOTO) programs. Ability to read, write and interpret technical documents and instructions, electrical and mechanical drawings, equipment blueprints and piping and instrumentation drawings (P&ID). Must have customer service and leadership attitude to take ownership of any maintenance related problem. Excellent communication and leadership skills. A self-starter with the ability to work independently and use good judgment. Must be able to handle multiple priorities. Must be proactive, results orientated, and have a strong attention to detail. Must be able to work overtime on a short notice and support standby program. Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. Must be able to lift, push, pull and carry up to 50 lbs. In general, the position requires a combination of sedentary work and walking around observing conditions in the facility Must be able to climb ladders and move about in closed quarters facility non-manufacturing support areas. Non-Exempt Roles only: Must be able to work overtime as required. May be required to work in a confined area. Some Clean Room and cool/hot storage conditions. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. GMSGQ ZR1 LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - CA - Los Angeles U.S. Hourly Wage Range: $18.85 - $29.62 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, 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 USA - CA - Los Angeles Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt No

  • Griffith, CA

  • no content

Director, Global Regulatory Lead, GI & Inflammation

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $174,500.00 - $274,230.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Senior Director, Clinical Data Standards

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Director, Clinical Data Standards based remotely reporting to the Vice President, Clinical Data Operations & Standards. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: In collaboration with the Clinical Data Strategy & Operations Leaders, and TAU Leaders, and other functional area leadership to develop, establishes and drives strategy of Takeda’s global data standards, processes and technologies across the clinical data continuum for quality of deliverables and global data interoperability. Responsible for establishing and managing a Standards vendor to support Standards Management vision. Responsible for end-to-end Standards Governance to ensure proper utilization, adherence to standards governance and processes, and the ongoing, thorough assessment of library enhancements and deviations. Build relationships across the global Takeda organization and with vendor partners in support of the standards vision and implementation. Participates with and influences at industry standards forums in support of Takeda’s therapeutic areas. Serves as a resource to support questions raised by regulatory agencies. A CCOUNTABILITIES: Has advanced knowledge of all standard library components and metadata across data collection, analysis and reporting continuum. Works with Clinical Data Strategy & Operations Leaders, TAU Leaders, and other functional area leadership to develop, and adhere to, Standards Management vision and overall metadata management strategy. Leads cross-functional Standards initiatives internal or external to Takeda and helps to ensure coherence of standards initiatives across organization. Provides strategic guidance toward execution of comprehensive data continuum to staff and vendors acting as project managers or leads on cross-functional initiatives. Supervises staff and vendors developing standards library to ensure alignment to standards strategy. Develops training strategy and ensures consistent training program for standards. Provides senior oversight to vendor/CROs for utilization of Takeda standards. Conducts ongoing review and development of metrics to assess standards utilization and development trends. Oversees Standards Governance, managing deviations from standards content and processes. Drives ongoing development and improvement of industry standards and provides leadership to external professional activities and organizations, such as CDISC, SCDM, EDC users group, SAS users group, Third Party Data Acquisition groups, etc. Actively communicates submission standards and guidance documents, regulatory agency expectations and industry trends to Takeda organization. Complies with all applicable regulatory expectations. ​ EDUCATION AND EXPERIENCE: BS/BA or MS in a life science or analytical area. 12 years data management and/or database or statistical programming experience in pharmaceutical industry or health related field. 8 years of experience supporting clinical trials across all phases of development. 5 years of progressive management experience. Proven track record for development and management of a standards library. In-depth knowledge of data management systems and processes, analysis and reporting principles. Good knowledge of statistical programming languages (e.g. SAS). Technical expertise (e.g. Windows NT and UNIX operating systems) and familiarity with common software products and technologies used in conjunction with SAS. Expertise in the requirements and technology required to support electronic data capture and electronic submissions. Proven track record in identifying and implementing organization-wide initiatives, standards, and processes. Proven track record in managing global, cross-functional standards and processes. Knowledge of medical and statistical terminology. Comprehensive understanding of pharmaceutical standard initiatives such as CDISC (ADaM, SDTM, CDASH and ODM), HL7, etc.) Able to influence without authority. Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo. Pragmatic and willing to drive and support change. Is comfortable with ambiguity . Support a culture of continual improvement and innovation; promote knowledge sharing. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. LI-Remote

  • Boston, MA

  • no content

Senior Manager, Feasibility

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&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: Conduct data-driven feasibility assessments for Phase I – IV clinical studies, including protocol design optimization, country/site feasibility and selection, enrollment strategy, and modeling. Use all competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, and accurate enrollment plans. Contribute to implementing creative processes, methodologies, data and technologies to ensure ongoing delivery and continuing improvement of Feasibility and Enrollment Forecasting Services. Participate in and/or lead global projects representing CSS&E and GDO to support Takeda R&D goals. A CCOUNTABILITIES: Develop feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda's operational execution of its clinical research studies. Ensure standards are applied to the feasibility process across project portfolios and direct continuous improvement activities while developing TA-aligned strategies. Collect and analyze all data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and establish a geographic country footprint and proposed sites for participation in a clinical study. Leverage leading industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, startup cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting. In partnership with internal stakeholders- combine and integrate data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution. Monitor actual patient enrollment performance of assigned studies. In collaboration with the Takeda study team and CRO, responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g. change in drug landscape, protocol amendment, increased screen failure rate). Determine risk/ mitigation planning. Maintain current therapeutic area knowledge and assess impact of evolving information on operational strategies. Exhibit the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment. Ability to provide data-driven recommendations to assist with decision making at a study level as well as provide program level support to help define asset strategy. Through strong analytical skills, develop deep insights, uncover unmet needs, collaborate within a global matrixed team. Act as a role model for Takeda’s values. ​ EDUCATION AND EXPERIENCE: BS degree or international equivalent required; 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

  • Boston, MA

  • no content

Associate Director, Global Regulatory Affairs Marketed Products

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. As an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provide strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Are a leader within the department and within R&D contributing to department and cross functional Takeda initiatives and influencing the field as applicable. Provide leadership/contributes as global regulatory lead (GRL) responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. How you will contribute: The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings as global and/or regional regulatory lead. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed in line with changing regulatory and business needs. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement, and communicating in a professional and timely manner. Proactively anticipates risks and develops solutions/scenario planning for identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for execution of global regulatory strategy including the provision of global regulatory submissions to local Takeda affiliates in compliance with local regulatory working with regional leads, other functions and vendors. Accountable for US FDA submissions and approvals of project(s). The Associate Director will lead all submission types. Serves as the primary FDA contact. Leads and manages FDA meetings. Responsible for demonstrating Takeda leadership behaviors. Manages junior staff as needed. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Supports the lead regulatory reviewer in due diligence for licensing opportunities. Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates solid, increasingly independent regulatory strategy skills, including an understanding of core regulatory concepts and their organizational and global implications. Proactively identifies regulatory issues and proposes creative, practical solutions and strategies, including risk mitigation. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Executive Director, Head, Global Regulatory Information, Data & Systems

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE: Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory Information, Data and Systems (GRIDS) is responsible for developing and implementing a comprehensive GRIDS strategy. This pivotal role ensures Takeda’s regulatory data integrity while driving the adoption and efficiency of Regulatory systems globally. This role involves guiding and mentoring a team of experts, driving regulatory data quality confidence, ensuring global system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the enterprise. Additionally, the role leads accurate and timely reporting for both common and ad hoc regulatory affairs questions. ACCOUNTABILITIES: Global GRIDS Strategy Development and Realization: In partnership and collaboration with GRA and GRO leadership, Takeda IT functions, R&D cross-functional, and enterprise stakeholders, develop and align global GRIDS strategy and roadmap. Execute and track GRIDS strategy through agreed to set of milestones, key deliverables, activities, and monitor progress through metrics. Proactively identify and manage risks and issues. Ensure ongoing stakeholder engagement and awareness throughout. Align and structure internal GRIDS team to enable strategy realization and deliverables. Define team roles and responsibilities and ensure alignment across GRO and other functions to ensure clarity and synergy. Develop and implement team norms and ways of working, driving delivery focus and prioritization. Actively mentor and guide direct reports in the execution of deliverables. Ensure external vendor support for GRIDS activities is clearly defined and, in partnership with Business Operations team, is delivering to specified service level agreements. Actively provide vendor oversight and engage with vendor(s) to ensure process and ways-of-working clarity and adoption. Data Governance and Sustainability: Establish robust regulatory data governance and stewardship practices and ensure data quality assurance for authoritative regulatory data sources. Proactively drive data remediation efforts as needed to ensure high data quality. Lead initiatives for regulatory information standards adoption and ensure organizational readiness to meet regulatory requirements, including eCTD4, SPOR/IDMP, and CTIS/EU CTR. Oversee master data management for regulatory data and partner/ drive connectivity with RD and enterprise systems. GRIDS Data Analytics: Drive GRIDS business intelligence and data visualization capabilities to support data-driven decision making for Therapeutic Areas Units (TAUs), regulatory leadership, and other stakeholders for pipeline realization and post-approval lifecycle management. Provide standard regulatory reports and dashboards and produce ad-hoc and custom regulatory reports as requested. GRIDS System Business Ownership: Partner with Takeda IT functions to drive the evolution, interoperability, data sharing, and integration of Takeda’s global GRIDS systems. Ensure business requirements are identified and adequately translated into system and supporting business process functionality. Support system release management, data migration and validation activities. Collaborate with GRA functions, regions, and local operating companies (LOCs) to drive system adoption and utilization. CORE COMPETENCIES: Strategy Development: Ability to create and implement long-term GRIDS strategies with a forward-thinking approach. Influential Communicator: Exceptional communication skills to articulate complex regulatory data concepts effectively. Collaborative Leader: Strong leadership qualities to guide cross-functional teams and drive organizational change. Innovative Thinker: Proactive in embracing innovation and leveraging technology to enhance RIM processes. Results-Oriented: Focused on achieving measurable outcomes and driving continuous improvement. Analytical Skills: Strong analytical skills to interpret regulatory data and deliver insightful reports and visualizations. QUALIFICATIONS: Minimum Bachelor's Degree, MS preferred; 15 years of experience in the life sciences, particularly in Regulatory Affairs and Regulatory Information, Data and Systems. Experience in leading global Regulatory Information, Data and Systems capabilities and teams. Credibility and experience engaging at senior levels for the development and alignment of GRIDS strategy. Ability to hold strategic conversations with Regulatory, R&D and enterprise stakeholders regarding global Information Management processes and systems and the regulatory applications and their use within Regulatory execution. Demonstrated experience in designing and implementing RIM digital transformation with proven ability to innovate across business processes and technology solutions. Experience with regulatory processes and technology for submission document authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. Experience with regulatory data standards, such as xEVMPD and IDMP. Deep understanding of the entire R&D value chain, particularly data taxonomies and domain integration. Understanding of global drug development & regulatory processes. Experience with Veeva RIM platform for health authority registration management. Experience directly working with Registration Management, Submissions, Submissions Archive, and Publishing technologies, a plus. Proven track record of thought leadership through industry presentations, publications, or other mechanisms, a plus. This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content