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Takeda Pharmaceutical Company Limited
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  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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:

    Takeda is seeking an Director to join our AI/ML & Data team in Boston, MA. This technical role focuses on implementing AI-driven drug discovery solutions across Takeda's key therapeutic areas and modalities, including small molecules and biologics. As a technical expert within our computational biology, chemistry, and data teams, you will build and deploy state-of-the-art AI/ML technologies and mathematical models to accelerate target identification, validation, and drug discovery workflows. This execution-focused role offers the opportunity to develop advanced AI platforms and implement novel approaches, such as agentic systems and reasoning models, to enhance discovery efforts across oncology, neuroscience, and inflammatory diseases.

    Accountabilities:

    Build AI Solutions for Target Discovery: Develop and deploy AI/ML systems for target identification and validation in oncology, neuroscience, and GI² initiatives for small molecules and biologics. Process and analyze large-scale datasets to uncover novel therapeutic opportunities and biomarkers.Engineer Agentic Systems & Reasoning Models: Create and implement advanced AI systems, including agentic AI (e.g., multi-agent models, reinforcement learning) to automate hypothesis generation, experimental design, and data analysis, enabling efficient small molecule and biologic drug discovery.Develop AI-Integrated Tools: Build and maintain AI/ML models that integrate biological, chemical, and omics data, ensuring computational outputs provide actionable insights for drug optimization.Implement Machine Learning Models: Code and deploy state-of-the-art machine learning algorithms, including deep learning, graph-based models, and active learning approaches, to power in silico screening, molecule design, and biological predictions for oncology, neuroscience, and GI² drug discovery.Build Knowledge Graphs & Foundation Models: Develop and maintain knowledge graph technologies and foundation models (e.g., language models) that integrate diverse data sources (omics, literature), supporting scientific reasoning and hypothesis testing across drug discovery workflows.Execute Cross-Functional Deliverables: Collaborate with computational biology, chemistry, and digital sciences teams to implement AI solutions within experimental workflows. Ensure model outputs are production-ready and provide tangible insights across oncology, small molecule, biologics, and GI² initiatives.Develop AI Research Tools: Create and optimize AI-enhanced research tools for small molecule and biologic discovery. Build novel AI/ML implementations that can generate intellectual property.Technical Mentorship: Provide practical technical guidance to team members, demonstrating best practices in coding, model development, and AI implementation across Takeda.Technical Documentation & Communication: Document AI system architectures and model implementations effectively. Present technical solutions to scientific stakeholders to support decision-making across Takeda's R&D efforts.Educational Background: Ph.D. in Computer Science, Data Science, AI, Computational Biology, or related field preferred (or M.S. with significant relevant experience). Strong practical coding skills and proven experience building AI/ML systems for drug discovery.Technical AI/ML Expertise: 8+ years of experience building and deploying AI/ML or mathematical modeling solutions for drug discovery challenges. Demonstrated success implementing production-level systems independently. Direct experience coding novel AI systems (e.g., agentic systems, reasoning models) is highly advantageous.Proven Development Track Record: Extensive experience writing production code for machine learning systems (e.g., deep learning, reinforcement learning, graph models, active learning) in drug discovery settings.Applied Computational Experience: Practical experience implementing AI/ML models for small molecule and biologic drug discovery, with proven ability to create functional tools that translate computational outputs into experimental insights. Experience in oncology, neuroscience or GI² therapeutic areas is advantageous.Technical Stack Expertise: Advanced proficiency in Python, with experience building on cloud platforms (AWS, Azure, or GCP), and implementing solutions using machine learning frameworks (e.g., TensorFlow, PyTorch).Execution & Collaboration: Track record of successfully delivering AI/ML projects from concept to production within cross-functional teams. Demonstrated ability to implement working solutions that drive drug discovery programs.Technical Innovation & Documentation: History of developing novel AI implementations in scientific research, coupled with strong abilities to document and explain technical architectures to diverse audiences across the organization.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    PhD degree in a Computer Science, Data Science, AI, Computational Biology, or related field preferred with 10+ years experience , or MS with 16+ years experience, or BS with 18+ years experienceStrong practical coding skills and proven experience building AI/ML systems for drug discoveryTechnical AI/ML Expertise: preferably 10+ years of experience building and deploying AI/ML or mathematical modeling solutions for drug discovery challenges. Demonstrated success implementing production-level systems independently. Direct experience coding novel AI systems (e.g., agentic systems, reasoning models) is highly advantageous.
    Proven Development Track Record: Extensive experience writing production code for machine learning systems (e.g., deep learning, reinforcement learning, graph models, active learning) in drug discovery settings.Applied Computational Experience: Practical experience implementing AI/ML models for small molecule and biologic drug discovery, with proven ability to create functional tools that translate computational outputs into experimental insights. Experience in oncology, neuroscience or GI² therapeutic areas is advantageous.Technical Stack Expertise: Advanced proficiency in Python, with experience building on cloud platforms (AWS, Azure, or GCP), and implementing solutions using machine learning frameworks (e.g., TensorFlow, PyTorch).Execution & Collaboration: Track record of successfully delivering AI/ML projects from concept to production within cross-functional teams. Demonstrated ability to implement working solutions that drive drug discovery programs.Technical Innovation & Documentation: History of developing novel AI implementations in scientific research, coupled with strong abilities to document and explain technical architectures to diverse audiences across the organization.If you are ready to be part of a forward-thinking, engineering-driven team at Takeda, contributing to transformative innovations in drug discovery through technical implementation, we encourage you to apply for this Associate Director role.

    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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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 company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as the Executive Director of Clinical Operations reporting to the Head of Global Clinical Development Operations.

    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 towards excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

    Here, you will be a vital contributor to our inspiring, bold mission.

    The Executive Director of Clinical Operations will act as a role model for Takeda's values and be responsible for leading and participating in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives. This individual will also be responsible for functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment.

    Objectives:

    Serve as the Global Clinical Development Operations leader within the assigned therapeutic area/business unit; establish and maintain collaborative relationships with cross-functional stakeholders and peers.Represent GCDO in all TA-specific forums, review boards and meetings; provide leadership/functional input into all study and program-related documentation, including the Asset Strategy, Clinical Development Plan, Protocol, etc.Responsible for clinical operations strategy, including the successful execution and management of global clinical programs in assigned therapeutic area(s) or business units, in support of the Clinical Development Plan (CDP).Responsible for financial planning/forecasting and budget management for all studies/programs within the assigned therapeutic area(s) or business units; responsible for administrative budget oversight for direct and indirect reports.Establish and maintain effective relationships with strategic partners and vendors; serve as primary point of contact at the therapeutic area/business unit. Ensure transparency of risks, mitigation plans and escalations with cross-functional leaders within the therapeutic area (including TAU leadership).Support the development of consistent Clinical Operations processes and ensuring the implementation of a unified approach across therapeutic areas.Initiate, develop, lead and/or participate in global initiatives representing Clinical Operations, in support of Takeda R&D objectives.Accountabilities:
    Collaborate with global functional heads and TA leadership to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Accountable for on-time, high-quality and on-budget delivery of clinical trials within the assigned therapeutic area/business unit.Chair the Operational Strategy Review meetings and ensure implementation of aligned operational strategy for all studies within the therapeutic area(s)/business unit.In collaboration with Study Management leadership, assess resource needs within the assigned therapeutic area/business unit; effectively manage optimal deployment of resources.Ensure clinical operations deliverables and work product are compliant with global regulatory and compliance requirements for clinical research, including but not limited to FDA Code of Federal Regulations, EUCTR, ICH GCP and local country requirements.Responsible for oversight of clinical budget planning/forecasting and management for assigned therapeutic area.Ensure compliance with regulatory requirements, industry standards, and internal policies throughout the clinical trial lifecycle.Oversee, review and approve operational due diligence for new compounds/alliances (both early and late stage); partner with TAU/BU representatives and the Centralized Due Diligence function to ensure delivery of appropriate assumptions, trial budgets, timelines, and enrollment models.Maintain current therapeutic area knowledge and continually assess impact of new and evolving information on operational strategies.Escalate issues related to quality, timelines and budget and provide recommendations to upper management for resolution of these issues.Support all CRO and vendor partnerships by participating in strategic vendor governance, including risk mitigation and identification/resolution of performance issues.When necessary, communicate risks and escalate issues related to quality, timelines and budget; provide recommendations and solutions to TAU leadership to support resolution of issues.Lead and/or participate in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives.Responsible for functional leadership in global clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment.Act as a role model for Takeda's values.Competencies:
    Deep oncology experience through Phases I-IV.Managing large complex global studies.Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to FDA Code of Federal Regulations, EUCTR, ICH GCP and local country requirements. Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).Previous line management or direct management of team members.Education & Experience:
    Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.15+ years' experience in the pharmaceutical industry and/or clinical research organization, including 12+ years clinical study/program management, including at least 6 years of line management experience.

    Ability to travel domestically and internationally up to 25%, travel reimbursed

    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:
    $205,100.00 - $322,300.00

    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.

    #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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:

    Reporting to the Head of Strategic Partnerships and Outsourcing, the Executive Director Clinical Partner Outsourcing (CPO) is a strategic leadership role responsible for ensuring all outsourced clinical study contracts are negotiated and contracted in line with best practices and processes, optimizing costs and supplier performance at the study level across Therapeutic Areas (TAs). The Head of CPO is responsible for developing and leading a high performing team focused on negotiation, contract management, and cost optimization, in support of efficient execution of clinical trials. The Head of CPO will also partner closely with Procurement and other key stakeholders to ensure delivery occurs in line with business requirements, while ensuring adherence to cost structures and governance frameworks.

    Accountabilities:

    With the Head, Strategic Partnership and Outsourcing, develop and implement short- and long-term strategy for Clinical Partner Outsourcing that is aligned with R&D strategyProvide strong leadership to the team, including growing and developing strategic and emerging competencies for outsourcing managers responsible for ballparking, Statements of Work (SOWs) and Change Orders to ensure alignment with business requirements, cost ceilings and commercial constructsDevelop and implement best practices for cost optimization and contracting approaches across the portfolioMaintain and enhance financial discipline leveraging cost workbook to ensure adherence to cost structures and partner with Enablement Team on continuous improvement opportunitiesCollaborate with SRM teams for operational and executive governance and support aggregated supplier scorecards that drive supplier performance improvementsCapture and analyze operational data points to identify variances and opportunities for optimization and lead the development of performance metrics to support study level scorecardsPartner with Therapeutic Area (TA) Business Partners to prioritize resources and ensure alignment to business requirementsWork closely with the Enablement Team to ensure consistent adoption of best practices, knowledge sharing and optimize ways of workingActively participate in Value Analysis/Value Engineering (VA/VE) activities to drive execution of optimization initiativesFoster a culture of continuous improvement by identifying and implementing process improvements and innovative solutionsUnderstand CRO study-related activities and throughputs to inform insourcing capabilities and optimize study executionDevelop and maintain a training and coaching program to upskill the team in clinical, commercial, financial, and negotiation capabilities, and support junior members to progress into senior rolesIdentify and lead automation, productivity improvements, and standardization initiatives, in line with company objectivesFoster strong industry collaborations to ensure continuous exchange of innovative ideas and best practicesEnsure compliance with all applicable internal policies and procedures, regulations; support inspection readiness of all regulated activities.Education & Competencies (Technical and Behavioral):
    BS/BA required; advanced technical degree preferred15+ Years of clinical outsourcing experience including at least 6 years of line management experienceProven exceptional experience in financial and commercial managementHighly skilled in cultivating a high-performance culture through coaching, people development and empowermentTransformational leadership capabilities driving cultural change by promoting best practices and continuous improvementAdvanced knowledge and experience in supplier relationship management and contract managementStrong understanding of clinical development operations, regulatory requirements, sourcing strategies, procurement processes and value engineering (VA/VE)Demonstrated leadership in stakeholder management and cross-functional collaboration leading complex, global projects and relationshipsStrong skills in engaging with senior leaders and external partnersForward-thinking approach with a focus on continuous improvementStrong understanding of GCP, ICH guidelines, and clinical trial regulationsADDITIONAL INFORMATION
    The position will be based in Cambridge, MA. This position is currently classified as "hybrid" by Takeda's Hybrid and Remote Work policy.Takeda Compensation and Benefits Summary

    We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    For Location:
    Boston, MA

    U.S. Base Salary Range:
    $208,200.00 - $327,140.00

    The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

    U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. 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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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

    Position Overview

    We are seeking an innovative and dynamic leader to spearhead our emerging research efforts in AI/ML-driven drug discovery with an initial focus on large molecule design. This role will build and lead 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, combined with proven leadership in a research environment.

    Key Responsibilities

    Strategic Research Leadership

    Develop and execute a research strategy that leverages AI/ML to advance our drug discovery efforts with specific focus on de novo design and optimization of large molecules.

    Stay abreast of emerging trends and technologies in AI/ML and their application to pharmaceutical research, including foundation models for protein design, diffusion-based modeling approaches, protein ligand co-folding, generative chemistry, and AI-driven target discovery.

    Serve as a central hub connecting AI/ML methodological expertise with domain-specific needs across Computational Science and Data Strategy teams, enabling synergistic collaborations that accelerate innovation

    Drive integration of the modeling pipelines with internal data foundation platforms, building a continuous test-and-learn pipeline through experimental validation by collaborating across scientific disciplines and therapeutic areas

    Team Building and Management

    Recruit, mentor, and manage a high-performing, cross-disciplinary research team focused on the development and implementation of state-of-the-art AI/ML methodologies with an initial focus on computational protein design.

    Foster a collaborative, innovative, and inclusive team culture that encourages creative problem-solving and cross-functional collaboration.

    Provide regular performance feedback, career development, and guidance to team members.

    Project and Program Management

    Oversee the planning, execution, and timely delivery of research projects, ensuring alignment with strategic milestones and corporate objectives.

    Ensure robust project management practices are in place, including risk assessment, progress tracking, and resource allocation.

    Design partnership models where computational biology teams provide domain expertise while the AI/ML team delivers advanced methodological solutions, creating force-multiplying collaborations

    Scientific Collaboration and Communication

    Champion AI/ML approaches across computational sciences and Research, building cross-functional communities of practice.

    Present research findings and strategic updates to internal stakeholders, senior management, and at external scientific conferences.

    Establish and nurture collaborative relationships with academic institutions, technology partners, and industry experts.

    Contribute to the preparation of patent filings and scientific manuscripts.

    Communicate and explain the strengths and weaknesses of complex computational models and ML techniques to diverse scientific audiences.

    Innovation and Continuous Improvement

    Drive the development and adoption of novel computational tools and methodologies to enhance our capabilities in computational biology, target discovery, large molecule design and structural modeling.

    Design effective strategies for implementing multimodal AI systems that integrate sequence, structure, and functional data for therapeutic candidate optimization.

    Evaluate and integrate emerging software and hardware solutions to support advanced AI/ML research initiatives.

    Qualifications

    Ph.D. in computer science, statistics, computational biology, or a related field with a focus on machine learning. 15+ years experience , or
    MS with 21+ years experience, or BS with 23+ years experience10+ years of research experience in AI/ML, computational drug design, structural modeling, or related disciplines within the pharmaceutical or biotechnology industry.Demonstrated success leading multidisciplinary research projects from conception through to impactful outcomes.Proven track record of scientific publications and presentations in relevant fields.Demonstrated expertise in machine learning algorithms, deep learning architectures, transformer-based models, and statistical modeling as applied to molecular design and developability.Strategic vision for integrating foundation models (e.g., ESM, AlphaFold) into drug discovery workflows with demonstrated impact on therapeutic programs.Proven track record in developing machine learning models for antibody design, protein-ligand co-folding, and/or related structural modeling approaches.Proven ability to bridge methodological AI expertise with domain-specific biological knowledge, creating collaborative environments that produce synergistic outcomes.Proficiency with programming languages (e.g., Python, R, C++) and ML frameworks (e.g., PyTorch, Tensorflow) with experiencing scaling computational infrastructure for large model training in cloud environments.Exceptional leadership, project management, and communication skills, with ability to translate complex computational insights to diverse scientific audiences and align with therapeutic portfolio priorities and R&D objectives.Strong problem-solving aptitude and strategic thinking with an entrepreneurial mindset.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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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:

    We are seeking a seasoned and visionary Senior Director of Medicinal Chemistry to join our leadership team. This individual will play a pivotal role in shaping the future direction of our company by providing strategic guidance and oversight to our medicinal chemistry efforts. The ideal candidate will be instrumental in driving our drug discovery initiatives forward, ensuring their successful progression and alignment with our company's overall goals and objectives. By leveraging their expertise, they will significantly influence our strategic decisions and contribute to the advancement of our scientific and commercial endeavors. Additionally, this person will oversee external programs at CROs, managing the design, execution, and progression of medicinal chemistry projects conducted exclusively at these organizations.

    Accountabilities:

    Create business development opportunities that meet the strategic scientific, therapeutic, and commercial needs of the organization or specific Therapeutic Area (TA).Leadership and Strategy: Provide strategic leadership and oversight to the medicinal chemistry department, aligning with the company's overall goals and objectives.Project Management: Oversee the design, execution, and management of medicinal chemistry projects conducted exclusively at CROs, ensuring timely progress and high-quality outcomes.Team Development: Mentor and develop a team of internal chemists, fostering a collaborative and innovative work environment.Collaboration: Work closely with cross-functional teams, including biology, pharmacology, and clinical development, to advance drug candidates from discovery through development.Innovation: Drive innovation in medicinal chemistry through the integration of new technologies, methodologies, and best practices.Regulatory Compliance: Ensure all activities comply with relevant regulatory requirements and industry standards.External Partnerships: Build and maintain relationships with external partners, including academic institutions, industry collaborators, and contract research organizations.Education & Competencies (Technical and Behavioral):

    Expected education and experience: PhD degree in Chemistry, Medicinal Chemistry or related discipline with 15+ years experience in small molecule projects.Proven track record of leading successful drug discovery programs, preferably in large pharma.Leadership Skills: Strong leadership and managerial skills with experience leading and developing high-performing teams.Technical Expertise: Deep understanding of medicinal chemistry principles, drug design, and optimization processes.Communication: Excellent verbal and written communication skills, with the ability to effectively communicate complex scientific concepts to a broad audience.Problem-Solving: Strong analytical and problem-solving skills, with a proactive and innovative approach to challenges.Collaboration: Proven ability to work collaboratively in a cross-functional team environment.Adaptability: Ability to adapt to changing priorities and work effectively in a fast-paced and dynamic environment.Preferred Qualifications:
    Experience: Experience in a leadership role within a large pharmaceutical or biotechnology company is highly desirable.A proven track record of leading projects that are completely outsourced.Publications: A strong publication record in medicinal chemistry or related fields.Patents: Experience with patent filings and intellectual property management.Networking: Established network within the scientific and pharmaceutical community.

    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:
    $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.

    #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description

    About the role:

    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

    Join Takeda as an Associate Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.

    You will also communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development/due diligence activities. Proactively recognizes and contributes to enhancing business processes.

    As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC.

    How you will contribute:

    Plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.Member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within the organization.Support submission team members to define CMC content (data and documentation) requirements for regulatory submissions and reviews the content for conformance with established requirements.Support and/or contribute to business process development and enhancement.Evaluate new business development opportunities or participate on due diligence teams.Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.Responsible for ensuring that 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.Exercise good judgement in elevating and communicating actual or potential issues to line management.Communicates and negotiates with international Health Authorities as necessary, directly and indirectly.Represent Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.Mentor and develop staff, if required, including staff professional development and project oversight accountability.Evaluate change proposals for regulatory impact and filing requirements.Minimum Requirements/Qualifications:
    BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead with late-stage development, marketing application experience strongly preferred.Significant Small Molecule experienceProven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams.Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.Demonstrates leadership, problem-solving ability, flexibility and teamwork.Exercises good judgement in elevating and communicating actual or potential issues to line management.Willingness to travel to various meetings, including overnight trips.Requires approximately up to 10-30% travel.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-AA1

    #LI-Hybrid

    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
    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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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 Associate 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 preferredAdvanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred6+ years of pharmaceutical industry experience. This is inclusive of 4+ years of regulatory experiencePreferred 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:
    $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
    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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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 Head of Contract Management (Director Level) is a highly experienced professional responsible for ownership of the Pricing, Value, and Access contracting process for Takeda Oncology's products and providing best in class service and subject matter expertise to business partners and key stakeholders. This individual would be accountable for the entire contract lifecycle from negotiation to execution and ongoing management, ensuring compliance with industry regulations and company policies while maximizing business opportunities for Takeda.

    PVA's primary commercial contracting customers include health plans, Pharmacy Benefit Managers (PBMs), specialty pharmacies, group purchasing organizations (GPOs), wholesalers and distributors. Government contracting includes State Medicaid and the VA Federal Supply Schedule contract. The Head of Contract Management is comfortable pivoting among these various customers and users with high-impact and quality solutions, creating customer value that improves people's lives.

    How you will contribute:

    Drive Market Access contract lifecycle beginning with business case development, demonstrating rationale and ROI supporting the contract proposal, through completion of the negotiation process and contract execution.Draft, negotiate and review all Market Access agreements in accordance with approved guidelines and strategies.Draft high quality, professional customer communication and correspondence.Draft Letters of Intent for new contract offers.Partner with the Account Team in negotiating contract terms and conditions.Maintain a deep understanding of the contract templates, legal risk and liability, while seeking input from functional head to understand company position in each contract situation.Identify and highlight high risk terms in the agreements, and alert risks to management and account teams.Maintain and update contracting policies, procedures, and work-flow processes as needed, continuously seeking best-practice solutions and embracing opportunities of new technologies to maintain an agile working environment.Review and understand reimbursement strategies, including price protection arrangements, where applicable, and explain them to other teams and internal customers as necessary to ensure proper analysis of deal.Support field sales and Market Access account management teams, legal, finance, government pricing, compliance, etc. to ensure proposals and contracts are prepared accurately and in a timely manner, and assist in the development of periodic business reviews with internal leadership and customers.Provide guidance and support on questions of contract interpretation to ensure contract compliance, particularly with respect to accurate payments that impact forecasting and reserves.Track, organize and maintain files of all contracts and supporting documents in accordance with company filing process.Remain current on key health care reform matters that impact contracting, achieve deep understanding of payer channels including managed care organizations, PBMs, specialty pharmacies, government contracting channels, health care exchanges, etc.Work with business partners in Government Pricing and Contract Operations to ensure appropriate price reporting, validation, and calculation of payments in Model N revenue management system, and timely and accurate payments to customers in accordance with the contract terms.Respond to inquiries from customers and field account managers regarding Market Access and Medicaid contract program specifics and performance details.Actively participate in meetings, fully prepared as the SME on PVA contracts.In conjunction with Legal, advise stakeholders of contractual rights and obligations and provide interpretation of terms and conditions and other contractual elements.Use of strong and persuasive verbal communication skills to execute and communicate effectively in a highly fluid, interactive, matrixed environment.Responsible for leading Pricing Committee, Contract Governance Committee, and Business Case process and all meeting minutes, policies and improvements related to these processes.Monitor existing customer contracts using approved performance methodologies and identifying and recommend opportunities for improvement.Responsible for providing contractual background and approvals for final contract execution.Minimum Requirements/Qualifications:
    Bachelor's degree with 10+ years of pharmaceutical experience with Market Access background and experience.Proficiency in knowledge in the reimbursement and access as well as key Oncology stakeholders.Previous experience in legal drafting with deep knowledge of Model N.Launch experience is critical within the US marketplace.Strong knowledge of the reimbursement environment for pharmaceutical products.Preferred Qualifications:
    Experience in Oncology is highly preferred.JD educational level would be highly desired.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:
    $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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    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

    Senior Scientific Director, Clinical Pharmacology

    Boston, MA

    OBJECTIVES/PURPOSE

    The Plasma-Derived Therapies (PDT) Business Unit R&D group is committed to delivering innovative therapeutic solutions using plasma-derived therapies to address rare and complex diseases. At Takeda, we aim to exceed patient and healthcare provider expectations by unlocking the full potential of plasma-derived and plasma-oriented therapies for immunologic, hematologic, and other complex conditions.

    This role is pivotal to advancing PDT R&D projects and offers the opportunity to:

    Collaborate within a matrixed team environment, ensuring seamless integration of efforts across PDT BU functions and relevant Takeda R&D functions to achieve business and project goals.Lead strategic, scientific, and operational aspects of clinical pharmacology across multiple drug development programs with substantial technical and strategic autonomy, spanning clinical entry through life-cycle management.Drive the clinical pharmacology and pharmacometrics strategy to accelerate project progression through clinical stages and ensure robust life-cycle management.Act as the global CPED lead for PDT programs, contributing to regulatory submissions and facilitating interactions with regulatory bodies.Leverage strong strategic thinking, exceptional communication skills, and extensive expertise in Clinical Pharmacology and PK/PD to deliver impactful results.ACCOUNTABILITIES
    Design and oversee clinical pharmacology programs to support the development, registration, and commercialization of Takeda's plasma-derived products. Provide leadership as the Clinical Pharmacology Lead for multiple programs, integrating data across pharmacokinetic, pharmacodynamic, efficacy, and safety measures to optimize dosing strategies.Represent CPED on product development teams, providing expertise across all development phases, including dose finding/optimization, exposure-response, and pediatric development strategies. Partner with key functions to execute impactful Model-Informed Drug Development (MIDD) practices.Lead clinical pharmacology and/or Phase 1 clinical studies, from study design to execution and reporting, maintaining high standards for accuracy and compliance.Manage pharmacometrics projects, including non-compartmental PK analyses, PK/PD modeling, population PK/PD modeling and simulation activities to advance program progression and support regulatory submissions. Oversee outsourcing collaborations, including contracts, Statement of Work (SOW), budget management, and invoice approvals.Engage directly with regulatory agencies, representing clinical pharmacology in global regulatory meetings; contribute to regulatory deliverables, such as Investigator Brochures (IBs), product labeling, responses to regulatory queries, and filings while ensuring alignment with regulatory strategy.Author and review CPED Development Plans and Reports, as well as related sections of Clinical Study Reports (CSRs).Participate in business development evaluations by conducting due diligence and assessing potential opportunities.Uphold Takeda's commitment to Good Clinical Practices (GCP), compliance, and ethical standards.Mentor junior team members, fostering scientific excellence and supporting professional growth.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    A Ph.D., Pharm D, MD or an equivalent degree with 15+ years of clinical pharmacology experience in the biopharmaceutical industry.Educational background in clinical Pharmacology, biopharmaceutics, pharmaceutical sciences, biomedical engineering, or related fields.Skills
    Proven ability to manage clinical pharmacology and pharmacokinetics across multiple drug development stages and regulatory interactions, including label negotiations.Ability to work independently, take initiative, and meet deadlines with strong attention to detail.Proactive problem-solving and issue identification skills.Competency in establishing priorities, scheduling, and composing/proofing materials.Effective collaboration and influence within a matrix environment.Strong presentation skills and communication across organizational management levels.Demonstrated leadership in setting objectives, providing feedback, and appraising team performance.Sound decision-making with a strategic understanding of broader PDT R&D goals.Diplomacy, positive influence, and interpersonal capabilities.Excellent verbal and written communication, analytical, and organizational skills.Proven track record of managing external consultants/vendors efficiently.Knowledge
    Hands-on experience with pharmacometrics, PK/PD analysis, and statistical tools like NONMEM, Phoenix NLME, etc.Thorough understanding of Phase I clinical operations, drug development processes, and global regulatory requirements.Advanced knowledge of clinical pharmacology, pharmacometrics, and current regulatory guidance.Familiarity with biopharmaceutics requirements for clinical/marketing phases.In-depth knowledge of GCP regulations, with familiarity in GLP and GMP standards.Detailed understanding of cross-functional interfaces critical for drug development efficiency.Expertise in plasma-derived/related therapies (highly desirable).WHAT TAKEDA CAN OFFER YOU:

    • 401(k) with company match and Annual Retirement Contribution Plan

    • Tuition reimbursement Company match of charitable contributions

    • Health & Wellness programs including onsite flu shots and health screenings

    • Generous time off for vacation and the option to purchase additional vacation days

    • Community Outreach Programs

    Empowering Our People to Shine Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

    This job posting exclude Colorado applicants.

    #LI-Hybrid

    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. #J-18808-Ljbffr Read Less
  • By clicking the "Apply" button, I understand that my employment applic... Read More

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description

    About the role:

    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

    The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio. This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams.

    Defines, develops, and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations.Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.Participates in cross-functional initiatives within Global Regulatory Affairs and Takeda R&D.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 and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs.Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.Participates with influence in departmental and cross-functional task-forces and initiatives.Lead regulatory reviewer in due diligence for licensing opportunities.Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.Responsible for demonstrating Takeda leadership behaviorsMinimum 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 acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.Must work well with others and within global teams.Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.More about us:

    At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

    Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

    This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.

    #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:
    $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
    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. #J-18808-Ljbffr Read Less

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Astrid-Lindgren-Weg 12 38229 Salzgitter Germany