• 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: Takeda’s Lead Profiling team is building a new team of experienced, innovative, and collaborative researchers to partner with Drug Discovery Units to design and run high throughput automated assays on state-of-the-art robotic platforms to drive an industry-leading portfolio of drugs for various Therapeutic areas with high unmet medical needs. We are seeking a skilled Research Scientist to join our Lead Profiling and cross-functional discovery teams. Design and execute pre-clinical pharmacology assays on fully automated robotic platforms to support candidate selection, accelerating clinical translation of impactful therapies for patients with various disorders Provide deep scientific expertise in the design and execution of miniaturized, high throughput assays to support programs across cross-functional teams Leverage state-of-the-art automation to streamline complex biology screening workflows and manage data across various programs, in close collaboration with Takeda scientists and external partners Accountabilities Lead high throughput, fully automated, pharmacology studies to enable advancement of drug candidates into early clinical trials Design and execute pre-clinical pharmacology assays on fully automated robotic platforms to support candidate selection, accelerating clinical translation of impactful therapies for patients with various disorders Champion scientific integrity and rigor in data analysis, preparation, and interpretation of detailed protocols/SOPs Collaborate cross-functionally with Automation Engineers, Scientists and Data Science teams to support data-driven decision-making Proactively leverage state-of-the-art automation to streamline complex assay workflows and generate data to support various programs, in close collaboration with Takeda scientists and external partners Education For Location: Boston, MA U.S. Base Salary Range: $116,000.00 - $182,270.00 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 Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less
  • By clicking the “Apply” button, I understand that my employment 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. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may include one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC, with limited supervision and guidance. Independently leads Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee – GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content at all levels. Labeling Documents Authoring, Submission, and Labeling Negotiations Authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance. With adequate supervision and guidance, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products with appropriate supervision and guidance. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals with appropriate supervision and guidance. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content. and develops strategies and labeling language for assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement ~ Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Advanced scientific degree (MSc, PhD, or PharmD) preferred. ~8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience. ~ Knowledge of US and/or EU regulatory requirements and guidelines. ~ Knowledge of other relevant regional regulatory nuances and requirements. ~ Knowledge of scientific principles and regulatory/quality systems relevant to drug development. ~ CCDS, USPI and EU SmPC) for regulatory submissions to ensure compliance with regulations with minimal supervision and guidance. ~ Ability to develop target labeling profile (TLP) with minimal supervision and guidance. ~ Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as remote following Takeda's Hybrid and Remote Work policy. Massachusetts - Virtual The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. Read Less
  • Cook - Hilton Boston Logan  

    A Cook is responsible for preparing food items in accordance with reci... Read More
    A Cook is responsible for preparing food items in accordance with recipes and established standards in the hotel's continuing effort to deliver outstanding service and financial profitability. Starting hourly rate : $22.31 hourly What will I be doing? As a Cook, you would be responsible for preparing food items in accordance with recipes and established standards in the hotel's continuing effort to deliver outstanding service and financial profitability. Specifically, you would be responsible for performing the following tasks to the highest standards: Prepare food items according to designated recipes and quality standards Maintain cleanliness and comply with food sanitation standards at all times Manage guest orders in a friendly, timely and efficient manner Ensure knowledge of menu and all food products Stock and maintain designated food station(s) Visually inspect all food sent from the kitchen Practice correct food handling and food storage procedures according to federal, state, local and company regulations Prepare requisitions for supplies and food items, as needed What are we looking for? Since being founded in 1919, Hilton has been a leader in the hospitality industry. Today, Hilton remains a beacon of innovation, quality, and success. This continued leadership is the result of our Team Members staying true to our Vision, Mission, and Values. Specifically, we look for demonstration of these Values: Hospitality - We're passionate about delivering exceptional guest experiences. Integrity - We do the right thing, all the time. Leadership - We're leaders in our industry and in our communities. Teamwork - We're team players in everything we do. Ownership - We're the owners of our actions and decisions. Now - We operate with a sense of urgency and discipline In addition, we look for the demonstration of the following key attributes: Quality Productivity Dependability Customer Focus Adaptability What will it be like to work for Hilton? Hilton is the leading global hospitality company, spanning the lodging sector from luxurious full-service hotels and resorts to extended-stay suites and mid-priced hotels. For nearly a century, Hilton has offered business and leisure travelers the finest in accommodations, service, amenities and value. Hilton is dedicated to continuing its tradition of providing exceptional guest experiences across its global brands. Our vision “to fill the earth with the light and warmth of hospitality” unites us as a team to create remarkable hospitality experiences around the world every day. And, our amazing Team Members are at the heart of it all! 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. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Takeda is committed to creating better health for people and a brighter future for the world. Guided by our OneOncology vision, we are advancing a rapidly growing oncology portfolio with potentially first-in-class and best-in-class therapies, including antibody-drug conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access to transformative medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead – Oncology, where you will be part of the global regulatory team. In this influential role, you will lead a top-priority program, building cross-functional teams capable of translating complex challenges and ideas into actionable strategies. You will set global regulatory direction, provide expert guidance, and lead late-stage projects to ensure innovative and robust strategies are in place from development through registration and launch readiness for high-impact oncology programs. Lead global regulatory strategy for assigned programs across development stages. Provide strategic, operational and tactical regulatory insight on one or multiple complex global oncology projects in clinical development with focus on innovative ways of addressing barriers to development strategies as well as accelerating access of our products to patients Will be responsible for complex and potentially multiple projects within the Oncology TAU. Interfaces with the Global Project Team (GPT) to lead and support cross-functional company objectives. Serve as global regulatory lead (GRL)/ Franchise global regulatory lead (GRL) on cross-functional teams for priority programs, providing strategic input and regulatory expertise. Leads the Global Regulatory Teams (GRT) accountable for the development of innovative global strategies in line with applicable regulations to achieve business objectives for development of Oncology products. When necessary, seeks expert advice and technical support from functional stakeholders and senior management. Acts independently under the direction of a Global Regulatory Portfolio Lead and/or TA Head. May participate in or lead regulatory and company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRT members.  Ensures alignment of global regulatory strategies with Leadership Team. Presents meaningful regulatory assessments and regulatory recommendations to management.  Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercise sound judgement and communicating in a professional and timely manner. Accountable for US FDA submissions and approvals of project(s) of responsibility. May serve as the primary FDA point of contact for projects of responsibility. Accountable for independently ensuring all submission types are executed on time with high quality, including major submissions (NDA/BLA/MAA) For the project(s) of responsibility, collaborate with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility. Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Develop/author and execute global regulatory strategies for complex strategies. 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. May lead regulatory assessment as part of due diligence teams for licensing opportunities. Identify and propose solutions to management for any resource gaps for assigned project(s). BSc/BA Degree, scientific discipline strongly preferred. ~ Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred  ~12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience.  ~ Experience in reviewing, authoring, or managing components of regulatory submissions including for Late-Stage assets. ~ Solid working knowledge of drug development process and regulatory requirements. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. ~ Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. ~ Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. ~ Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory ~ Strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. ~ 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. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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. Join us as a Senior Medical Director, Solid Tumor in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. 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. The Senior Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for multiple Takeda pipeline compounds. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development issues. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. A significant error in judgment may result in loss of approvability and/or commercial viability of a product. Drives all Clinical Science department activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to the clinical scientists involved in these activities, and be accountable to senior company management for the successful completion of underlying objectives. For the assigned compounds, accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals. Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients. Trial Medical Monitoring Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance.  Directs activities involved in interactions with regulatory authorites/agencies and clinical development and key opinion leaders relevant to assigned compounds. Provides leadership and serves as an advisor to the other clinical scientists engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives. Due Diligence, Business Development and Alliance Projects Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge/understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds. Represents clinical science on high impact/priority task forces across the organization or external to the company. Conducts performance reviews and drive goal setting and development planning. MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned). Training and Experience in Hematology/ Oncology and/or Medical Oncology especially in solid tumor malignancies is highly preferred Experience in conducting and/ or leading clinical trials in involving immune based therapies and/or antibody drug conjugates is highly preferred  Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred Regional/global Regulatory requirements Emerging research in designated therapeutic area TRAVEL REQUIREMENTS: Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 15 - 25% travel. Read Less
  • Senior Research Analyst (BOSTON)  

    - Suffolk County
    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 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 : Research Senior Associate POSITION DESCRIPTION : Takeda Development Center Americas, Inc. is seeking a Research Senior Associate with the following duties: design and execute in vitro antibody discovery campaigns using yeast and phage display techniques. Independently conduct complex experiments, and implement display technologies to discover and advance novel biotherapeutic products through discovery and optimization stages. Generate diverse repertoires from immunized animals to build immune libraries for discovery purposes. Design and build maturation libraries for display platforms (affinity/potency/ stability), leveraging datasets and software to improve lead candidates. Prepare samples for sequencing by NGS or Sanger methodologies, including data analysis. Perform mammalian cell culture, ELISA and flow cytometry experiments, including sorting by utilizing BD Canto, ARIA and HT systems. Develop and use molecular cloning strategies for antibody gene amplification, library construction, and for generating antibody diversities for display libraries. Complete molecular biology techniques including DNA and RNA extraction, PCR, RT-PCR, restriction enzyme digestions and site directed mutagenesis. Exercise technical judgement in execution of specialized procedures and interpretation of results. Initiate routine problem investigation and recommend solutions; perform calculations and basic analysis on experimental results and develop hypotheses. Contribute to design of well-defined experimental procedures; maintain responsibility for routine laboratory instrumentation and supplies; track, collect, organize and analyze data from matrix teams; required to track data from LIMS systems and maintain detailed electronic notebook. Up to 20% remote work allowed. 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: Master’s degree in Biochemistry, Biotechnology, Molecular. Biology, Immunology Bioengineering, or related field, plus 1 year of related experience. Prior experience must include: design antibody discovery phage campaigns and strategize selections arms for given targets; build immune/single domain phage libraries using molecular biology techniques; independently handle and lead projects from discovery to clone selection for target discovery campaigns; design recombinant plasmids to generate overexpressing/knock-out cell-lines using molecular biology; develop high-throughput cell-based flow cytometry assays to screen potential antibody candidates to increase screening efficiency; laboratory experience in yeast and/or phage display, antibody discovery, molecular biology or related research role. Full time. $86,500 - $148,300 per year. Qualified applicants can apply at . Please reference job #R0175792 . 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 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 Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. We are looking for someone with strong practical experience with global HA requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Who has a proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. How you will contribute: Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements. Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes. Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities. Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions. Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics. Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations. Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale. Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings. Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact. Promote sustainable practices and scalability in site-level regulatory operations. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required. This can include experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Strong practical experience with global HA requirements, beyond EU/US. Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies directions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. #LI-Hybrid #LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. 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 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: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less
  • Primary Care Provider - Sign On Bonus Available (Boston)  

    - Suffolk County
    About UsOne Medical is a primary care solution challenging the industr... Read More
    About UsOne Medical is a primary care solution challenging the industry status quo by making quality care more affordable, accessible and enjoyable. But this isn t your average doctor s office. We re on a mission to transform healthcare, which means improving the experience for everyone involved - from patients and providers to employers and health networks. Our seamless in-office and 24/7 virtual care services, on-site labs, and programs for preventive care, chronic care management, common illnesses and mental health concerns have been delighting people for the past fifteen years. In February 2023 we marked a milestone when One Medical joined Amazon. Together, we look to deliver exceptional health care to more consumers, employers, care team members, and health networks to achieve better health outcomes. As we continue to grow and seek to impact more lives, we re building a diverse, driven and empathetic team, while working hard to cultivate an environment where everyone can thrive. Employment type:Full timeWhat you ll be working on:Managing a patient panel with a broad array of patient needs; conducting a mix of acute, chronic, and well visits Treating patients in-office or in testing centers as well as conducting occasional tele-health visits Continuous learning during weekly Clinical Rounds and through other modalities Ongoing collaboration with in-office teammates via daily huddles, as well as with virtual clinical teams Utilization of your specific clinical training and opportunities to perform in-office procedures Supervising one or more NP or PA colleagues Willing to obtain additional state licensure and credentialing for One Medical virtual primary care in additional statesEducation, licenses, and experiences required for this role:Enrolled in, or have completed, an accredited Internal or Family Medicine residency program Practiced at least 2 of the last 5 years in an outpatient primary care setting Board Certified in Internal or Family Medicine, or Board Eligible with plans to obtain board certification within 1 year of your One Medical start date State licensed in Massachusetts, obtained before your One Medical start dateOne Medical providers also demonstrate:A passion for human-centered primary care The ability to successfully communicate with and provide care to individuals of all backgrounds The ability to effectively use technology to deliver high quality care Clinical proficiency in evidence-based primary care The desire to be an integral part of a team dedicated to changing healthcare delivery An openness to feedback and reflection to gain productive insight into strengths and weaknesses The ability to confidently navigate uncertain situations with both patients and colleagues Readiness to adapt personal and interpersonal behavior to meet the needs of our patientsThis is a full-time role based in Boston, Massachusetts. One Medical is committed to fair and equitable compensation practices. The base salary range for this role is $252,000 to $267,800 per year. Total compensation packages may be based on factors unique to particular candidates, such skill sets, depth of experience, and work location. The total compensation package for this position may also include restricted stock unit grants, and/or benefits. For more information, visit https://www.onemedical.com/careers/. One Medical offers a robust benefits package designed to aid your health and wellness.All regular team members working 24+ hours per week and their dependents are eligible for benefits starting on the team member s date of hire: Taking care of you todayPaid sabbatical for every five years of service Free One Medical memberships for yourself, your friends and family Employee Assistance Program - Free confidential services for team members who need help with stress, anxiety, financial planning, and legal issues Competitive Medical, Dental and Vision plans Pre-Tax commuter benefits PTO cash outs - Option to cash out up to 40 accrued hours per yearProtecting your future for you and your family401K match Credit towards emergency childcare Company paid maternity and paternity leave Paid Life Insurance - One Medical pays 100% of the cost of Basic Life Insurance Disability insurance - One Medical pays 100% of the cost of Short Term and Long Term Disability InsuranceIn addition to the comprehensive benefits package outlined above, practicing clinicians also receiveMalpractice Insurance - Malpractice fees to insure your practice at One Medical is covered 100%. UpToDate Subscription - An evidence-based clinical research tool Continuing Medical Education (CME) - Receive an annual stipend for continuing medical education Rounds - Providers end patient care one hour early each week to participate in this shared learning experience Discounted rate to attend One Medical s Annual REAL primary care conferenceOne Medical is an equal opportunity employer, and we encourage qualified applicants of every background, ability, and life experience to contact us about appropriate employment opportunities.One Medical participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Please refer to the E-Verification Poster and Right to Work Poster for additional information. Read Less
  • This Job at a Glance Job Reference Id: ORD-192898-CRNA-MA Title: CRNA... Read More
    This Job at a Glance Job Reference Id: ORD-192898-CRNA-MA Title: CRNA Dates Needed: October - ongoing Shift Type: Day Shift Assignment Type: OR Call Required: No Board Certification Required: Yes Job Duration: Locums About the Facility A hospital is seeking a CRNA for locum tenens coverage. About the Facility Location The facility is located west of Boston, Massachusetts. About the Clinician's Workday This opportunity includes a variety of cases such as Bread and Butter, OB, Thoracic, OBGYN, and Complex General. Shifts are scheduled on weekdays from 7 AM (8 AM on Wednesdays) and typically run 10-12 hours. The facility uses EPIC for EMR. Credentialing takes approximately 6-8 weeks. The position includes a mix of supervision and solo work, with potential for overnight and weekend shifts. Additional Job Details Case Load/PPD: Varies Location Type: On-Site Prescriptive Authority Required: No Government: No Percentage Hands On: 0% Supervision/Medical Direction: Supervision Why choose LocumTenens.com? Our services are 100% free for clinicians and are designed for a seamless experience with every assignment: Precision job matching with proprietary algorithm Rapid credentialing with Axuall Digital Wallet Concierge support with a dedicated clinician deployment specialist Digital hub for assignment details Read Less
  • By clicking the Apply button, I understand that my employment applicat... 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 Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions. Precedent Search and Labeling Trends Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10+ years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience. Strategic Thinking Ability to develop execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately Read Less
  • Please send current resumes directly to bhagyashree.yewle@yoh.com Bhag... Read More
    Please send current resumes directly to bhagyashree.yewle@yoh.com Bhagyashree Yewle, Principal Lead Recruiter - YOH SPG https://www.linkedin.com/in/bhagyashreeyewle/ Data Analyst – U.S. Wealth Sales Enablement (Boston or Chicago)// prior experience focused on enabling sales teams with data-driven insights that lead to action Location: Hybrid onsite 3-4 days per week in Boston, MA or Chicago, IL Team: Sales Enablement – U.S. Wealth Distribution Type: Full-Time (FTE) from Day 1 or Right-to-Hire (Hiring Manger is flexible) Qualifications 4–6+ years of experience in sales analytics, business analytics, or financial services. Must have prior experience focused on enabling sales teams with data-driven insights that lead to action—helping wholesalers and relationship managers better target advisors, prioritize opportunities, and drive asset growth. Strong Excel skills (required); comfortable working with large, messy datasets Experience supporting sales, distribution, or revenue-generating teams Ability to turn data into clear, actionable recommendations for non-technical stakeholders Familiarity with wealth management or intermediary distribution (preferred) Experience with Salesforce, Tableau, or similar tools is a plus Python or SQL is a plus (not required) Strong communication skills and ability to influence sales stakeholders Overview Our client is expanding its U.S. Wealth business and is seeking Data Analysts to join the Sales Enablement team , supporting distribution across key intermediary channels. This is someone that comes from the business side as they will be supporting the wholesalers for Sales Enablement – U.S. Wealth Distribution team. This role is focused on enabling sales teams with data-driven insights that lead to action —helping wholesalers and relationship managers better target advisors, prioritize opportunities, and drive asset growth. This is a highly business-facing role , ideal for someone who enjoys working at the intersection of data, sales strategy, and distribution execution Key Responsibilities Partner directly with Sales Enablement, Sales, and Finance teams to deliver insights that drive commercial outcomes Analyze sales activity, asset flows, and advisor-level data to identify opportunities for growth and engagement Translate data into clear recommendations (e.g., next best actions, targeting strategies, campaign ideas) Support fund onboarding and distribution tracking across platforms such as LPL, Fidelity, Merrill, and Vanguard Leverage data from systems such as Salesforce, State Street, and transfer agents to build a complete view of distribution performance Help sales teams understand: Where business is coming from Which advisors to prioritize What opportunities may be missing Partner with Sales Enablement to design and evaluate targeted campaigns (e.g., email outreach, advisor segmentation) Build dashboards and reporting to improve data accessibility for a growing (~30–50 person) sales organization Develop into a subject matter expert (SME) on wealth distribution data, flows, and advisor behavior What You'll Be Working On Enabling wholesalers to get more meetings and deepen advisor relationships Identifying high-value advisors and untapped opportunities Analyzing product flows and platform performance Supporting sales strategy with data-backed insights Helping scale a data-driven sales enablement function from the ground up Estimated Min Rate $60.00 Estimated Max Rate $70.00 What's In It for You? We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include: Medical, Prescription, Dental Vision Benefits (for employees working 20+ hours per week) Health Savings Account (HSA) (for employees working 20+ hours per week) Life Disability Insurance (for employees working 20+ hours per week) MetLife Voluntary Benefits Employee Assistance Program (EAP) 401K Retirement Savings Plan Direct Deposit weekly epayroll Referral Bonus Programs Certification and training opportunities Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply. Yoh, a Day Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process. For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. 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. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh's hiring clients' preferences. To learn more about Yoh's privacy practices, please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice Read Less
  • B

    Medical Lab Scientist II - Boston  

    - Boston
    Position/Department SummaryPerforms a variety of routine and highly sp... Read More
    Position/Department Summary
    Performs a variety of routine and highly specialized diagnostic tests and specialized procedures. Assures quality of the results and communicates relevance of results to other health care professionals.

    Key Responsibilities:Performing a variety of moderate and highly complex and diagnostic laboratory testing under general supervision in the laboratory.May perform specialized procedures in special laboratory sections unique to each laboratory's discipline.Evaluating whether the results are abnormal/critical and takes appropriate action internally/externally according to laboratory guidelines.Recording results of tests with all supporting documentation for clinical interpretation.Performing regularly scheduled quality control, preventative maintenance, and calibration of equipment according to laboratory guidelines. Performs all troubleshooting and repair.Participating in department continuing education including training program expanding scope of knowledge.Providing general assistance to less experienced laboratory personnel.Communicating principle/theory to physicians and other professional staff.Ensuring accurate test results by following good lab practices. Can identify problems as if unsure of resolution seeks appropriate assistance.Performing a variety of special projects and additional work as needed/assigned.Observing guides, verifying and checks documentation of less experienced lab personnel.Training and teaching laboratory personnel and others. Contributes to the continuing education programMay act as lead in absence of supervisor/manager. May prepare schedule or draft procedures.Performing a variety of moderate to highly complex and specialized diagnostic laboratory testing.Performing special projects as assigned.May perform testing unique to the specific discipline in the laboratory and at the bedside.
    Minimum Qualifications
    Education:
    Associate's Degree AND successful completion of an ASCP/NAACLS accredited Medical Technology/Medical Laboratory Science program requiredBachelor's Degree AND successful completion of an ASCP/NAACLS accredited Medical Technology/Medical Laboratory Science program preferred.
    Experience:Minimum 3 years of Clinical Lab Science experience required5 years Clinical lab experience preferred
    Certification:National certification preferredCertification required for related science degreed individualsShift/hours:Monday - Friday (4- 10 hour shifts), 7:00am - 5:30pm including occassional on call coverage for Needham when neededLocation:BostonSign on Bonus:$7,500 one time sign on bonusEmployee Referral bonus:$2,000.00

    The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting.

    Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

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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. 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 Senior Scientists to develop agentic AI systems that transform how drug discovery research is conducted. As part of the AI/ML Foundation team, you will build autonomous AI agents capable of reasoning, planning, and executing complex scientific workflows—from literature synthesis and target identification to experimental design and data analysis. This role requires a unique combination of expertise in large language models, agentic frameworks, and understanding of drug discovery processes. You will translate standard research workflows into agentic frameworks, develop new agent skills, and deploy systems that augment scientist productivity across Computational Sciences and Global Research. Accountabilities: Develop agentic AI systems for drug discovery applications including target-disease association, automated literature search and synthesis, hypothesis generation, and intelligent design of experiments. Translate standard research workflows into agentic frameworks—decomposing complex scientific processes into autonomous agent tasks that can reason, plan, execute tools, and iterate based on results. Design and implement new agent skills (tools, functions, APIs) that extend agentic capabilities to specialized scientific domains including molecular design, property prediction, assay planning, and data analysis. Build agentic systems that integrate with foundation models and external knowledge sources for autonomous hypothesis generation, evidence retrieval, and scientific reasoning. Develop retrieval-augmented generation (RAG) pipelines connecting agents to internal and external scientific literature, databases, and experimental results. Partner with research scientists to understand workflow needs, validate agent outputs, and iterate on system design to ensure scientific rigor and utility. Stay current with advances in agentic AI, LLM applications, and scientific automation; contribute to internal knowledge sharing and external publications. Educational 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 Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less
  • Head of International Regulatory Strategy CMC (BOSTON)  

    - Suffolk County
    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. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:  Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle.   Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.  Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.  Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. As a GRA CMC member, ensures and / or enhances regulatory compliance.  Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.   Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.  When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Proactively identifies regulatory CMC risks, ensuring timely communication with line management.  Leads assigned global regulatory submissions (e.g., Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.  Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., to ensure effective strategies are implemented and project execution is on target.  Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. BS/BA Degree in a Scientific Discipline, Advanced Degree (M.10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. ~ Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.  ~ Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.     ~ Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.  ~ Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines  ~ At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and lon]] Read Less
  • Director, CMC Regulatory Affairs Worldwide (BOSTON)  

    - Suffolk County
    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. At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:  With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.   Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations.  With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.  With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.    Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.  When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target.  Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. BS/BA Degree in a Scientific Discipline, Advanced Degree (M.10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered).   ~ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.  ~ Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.    ~ Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.   ~ Able to deal with issues of critical importance with minimal supervision. At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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. #The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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 Title : Research Scientist, AI/ML – Agentic Systems Position Overview We are seeking a Research Scientist to develop agentic AI systems that transform how drug discovery research is conducted. As part of the AI/ML Foundation team, you will build autonomous AI agents capable of reasoning, planning, and executing complex scientific workflows—from literature synthesis and target identification to experimental design and data analysis. This role requires a unique combination of expertise in large language models, agentic frameworks, and understanding of drug discovery processes. You will translate standard research workflows into agentic frameworks, develop new agent skills, and deploy systems that augment scientist productivity across Computational Sciences and Global Research. Key Responsibilities Develop agentic AI systems for drug discovery applications including target-disease association, automated literature search and synthesis, hypothesis generation, and intelligent design of experiments. Translate standard research workflows into agentic frameworks—decomposing complex scientific processes into autonomous agent tasks that can reason, plan, execute tools, and iterate based on results. Design and implement new agent skills (tools, functions, APIs) that extend agentic capabilities to specialized scientific domains including molecular design, property prediction, assay planning, and data analysis. Build agentic systems that integrate with foundation models and external knowledge sources for autonomous hypothesis generation, evidence retrieval, and scientific reasoning. Develop retrieval-augmented generation (RAG) pipelines connecting agents to internal and external scientific literature, databases, and experimental results. Partner with research scientists to understand workflow needs, validate agent outputs, and iterate on system design to ensure scientific rigor and utility. Stay current with advances in agentic AI, LLM applications, and scientific automation; contribute to internal knowledge sharing and external publications. Qualifications Required: PhD in Computer Science, Computational Biology, Bioinformatics, or related field Experience with large language models (GPT, Claude, Llama) and their application to complex reasoning tasks. Proficiency in Python and experience with agentic AI frameworks (LangChain, AutoGen, CrewAI, or similar). Experience building RAG systems including vector databases, embedding models, and retrieval pipelines. Understanding of drug discovery processes and scientific research workflows. Strong problem-solving skills and ability to translate complex scientific processes into computational workflows. Preferred: Experience in pharmaceutical or biotech R For Location: Boston, MA U.S. Base Salary Range: $116,000.00 - $182,270.00 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 Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less
  • By clicking the “Apply” button, I understand that my employment 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 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 : Associate Scientist POSITION DESCRIPTION : Takeda Development Center Americas Inc. is seeking an Associate Scientist with the following duties: Lead from the lab to advance novel and differentiated products to the clinic by contributing to discovery projects focused on leveraging Vd1+ gamma delta T-cells as cancer treatment; Independently design, execute, and interpret well-defined functional in vitro, and ex vivo assays to understand the pharmacology and therapeutic mechanism-of-action of candidate molecules and play an active role in subsequent scientific discussions to drive decisions around Vd1 T-cells as a cancer therapy; Propose experiments based on internal results, external partners, and published reports and demonstrate leadership through effective communication of study plans and research results; Use immune cell characterization and functional assessments, such as high-parameter flow cytometry, multiplex cytokine measurement, co-culture cytotoxicity assessment, and other molecular- and cell-based assays and methodologies; Isolate, culture, and differentiate various immune cell populations from blood and tissue sources; Analyze, interpret, and present data to partners, and play an active role in the subsequent scientific discussions leading to important decisions and program-ensuring next steps; Participate in cross functional project team meetings to provide key scientific insight; Multi-task effectively and prioritize workload; Work collaboratively with internal cross-functional teams and acts as a Vd1 subject matter expert; Collaborate with other departments to meet deadlines and generate data crucial for the programs in execution; Contribute to the writing of relevant research reports to be included in regulatory filings; Prepare and present comprehensive technical or project reports and formal presentations and posters to full range of internal/external audiences; Maintain excellent laboratory notebook documentation and keep in compliance with Takeda policies. Up to 20% remote work allowed. REQUIREMENTS: Master’s degree in Biology, Biosciences, or related field plus 18 months of related experience. Prior experience must include: Isolate, culture and expand Vd1 gamma delta T cells from blood, healthy tissue and tumor sources; Design and execute in vitro/ex vivo assays of Vd1 gamma delta T cell function, including cytotoxicity, survival, and proliferation; Analyze experimental data and determine the relevance of results based on background knowledge of Vd1 gamma delta T cell biology; Contribute to evaluation of novel immunotherapy products based on Vd1 gamma delta T cell biology; The design and optimization of RNA-FISH PrimeFlow Cytometric Assays for the identification of Vd1 gamma delta T cells. Full time. $99,500 - $170,600 per year. Qualified applicants can apply at . Please reference job #R0174635 . 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 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. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Vice President , Global Clinical Lead - Solid Tumor in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Responsible for leading as the Global Clinical Lead a large solid tumor oncology franchise that encompass multiple late stage and early phase programs . Ensures ongoing review and agreement of the Therapy Area Strategy and associated documents formulated by the OTAU leader prior to their review and approval by appropriate governance committees. Responsible for review of synopses, other relevant clinical study documents and critical Study Results. Provide leadership and oversight of specific OTAU related programs and if applicable other indication specific clinical leads. Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned clinical studies. Consistent with the Takeda R&D Oncology Therapeutic Area Unit strategy, goals and objectives, this leader will partner with the other key functions and leaders and members of Oncology Precision and Translational Medicine, Oncology Portfolio Strategy Group, Global Regulatory Affairs, Quantitative and Clinical Pharmacology, other R&D Functional Line Oncology Therapeutic Area Leads, Global Product Launch Strategy Oncology Franchise Leads, Regional Oncology Franchise Leads, Oncology Drug Development Unit (DDU) and other Oncology extended leadership, to drive the alignment on global clinical research and development strategy as related to internal and external pipeline and non-pipeline initiatives for the Takeda R&D Oncology Community across all regions Part of the Oncology Clinical Sciences Leadership Team providing key input in strategic planning and connectivity for the overall Oncology Clinical Sciences group Leads the Global Development Team (US, EU, and others) managing both the US/EU Development Team and the Japan/ China Development team for assigned compounds. In some cases may lead the US/EU Development Team but more likely will oversee the study physician and/or clinical scientist leads responsible for leading the team. Emphasis will be on insuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Responsible for high impact global decisions: interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need. Primary interface with Medical Affairs team for strategy and to support of product commercial efforts Contributing to the creation and maintenance of regional KOL network Liaison with Clinical Operations and Project Management for co-ordination of logistics study planning and implementation ~ Consistent with membership of the Clinical Review Board Committee, responsible for critical review of synopses, protocols, IBs and relevant clinical documents relating to studies in assigned compounds.  ~ Trial Medical Monitoring ~ Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record for assigned compounds. ~ Oversees and leads all clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds.  Due Diligence, Business Development and Alliance Projects Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner. Assigns and manages clinical science staff who are involved in many of these activities. ~ Leadership, Task Force Participation, Upper Management Accountability Works with functional leadership to prioritize projects within the therapeutic area. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning. MD or combined MD/PhD or internationally recognized equivalent with minimum 15 years pharmaceutical research experience, including minimum 10 years late phase clinical development experience with a focus on medical oncology ~ Clinical Training and Clinical Experience in Hematology/Oncology and/or Medical Oncology especially in solid tumor malignancies ~ Strong depth of scientific and clinical understanding and experience in cancer biology especially in immune based therapies. ~ Experience in conducting and/ or leading multiple clinical trials involving immune based therapies ~ Proven experience in successfully leading and supervising direct reports including several physicians, physician scientists, scientists within a clinical development team in a global matrix environment. ~ Demonstrated ability to foster a high-performance culture and build organizational capabilities. ~ Strong leadership commitment to diversity, equity and inclusion, with experience in creating an inclusive and collaborative team environment that leverages diverse perspectives. ~ 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. 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. 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. We are seeking Senior Scientists to develop agentic AI systems that transform how drug discovery research is conducted. As part of the AI/ML Foundation team, you will build autonomous AI agents capable of reasoning, planning, and executing complex scientific workflows—from literature synthesis and target identification to experimental design and data analysis. This role requires a unique combination of expertise in large language models, agentic frameworks, and understanding of drug discovery processes. Develop agentic AI systems for drug discovery applications including target-disease association, automated literature search and synthesis, hypothesis generation, and intelligent design of experiments. Translate standard research workflows into agentic frameworks—decomposing complex scientific processes into autonomous agent tasks that can reason, plan, execute tools, and iterate based on results. Design and implement new agent skills (tools, functions, APIs) that extend agentic capabilities to specialized scientific domains including molecular design, property prediction, assay planning, and data analysis. Build agentic systems that integrate with foundation models and external knowledge sources for autonomous hypothesis generation, evidence retrieval, and scientific reasoning. Develop retrieval-augmented generation (RAG) pipelines connecting agents to internal and external scientific literature, databases, and experimental results. Partner with research scientists to understand workflow needs, validate agent outputs, and iterate on system design to ensure scientific rigor and utility. Stay current with advances in agentic AI, LLM applications, and scientific automation; PhD in Computer Science, Computational Biology, Bioinformatics, or related field with 2+ years relevant experience, OR MS with 6+ years relevant experience. Strong experience with large language models (GPT, Claude, Llama) and their application to complex reasoning tasks. Proficiency in Python and experience with agentic AI frameworks (LangChain, AutoGen, CrewAI, or similar). Experience building RAG systems including vector databases, embedding models, and retrieval pipelines. Understanding of drug discovery processes and scientific research workflows. Strong problem-solving skills and ability to translate complex scientific processes into computational workflows. Experience in pharmaceutical or biotech R&D environments. Experience with reinforcement learning or planning algorithms for agent decision-making. Familiarity with scientific databases (PubMed, UniProt, ChEMBL) and APIs. Experience deploying AI systems in production environments. Strong publication record or demonstrated thought leadership in AI for biology and molecular design. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.  S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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. Read Less

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