About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we constantly challenge what's possible, never simply accepting what has always been done. We reframe old problems, seek new solutions and operate comfortably in areas that are unknown. Our backgrounds are diverse, but our team shares a love of the outdoors and a desire to protect it for future generations. Role Summary Join Our Talent Community: We're always excited to connect with great talent. This posting is for future considerations of our Massachusetts locations as we continue to grow. While there isn't an immediate openings at these locations, we encourage you to apply if you're interested in being considered for upcoming opportunities. Addresses: Boston Spaces, 400 Newbury Street, Boston, MA 02215 Dedham Spaces (coming spring 2026), 480 Legacy Pl Dedham, MA 02026 Canton Service Center, 125 Shawmut Rd, Canton, MA 02021 Lynnfield Spaces (coming summer 2026) 600 Market St Lynnfield, MA 01940 As a Field Sales Advisor IV, you will be an integral member of our field sales organization, building relationships with prospective customers and expanding the Rivian community. You will manage the entire customer relationship from lead qualification to close, ensuring a personalized purchase experience throughout. You will educate and inspire customers using various communication channels including in-person interactions, demo drives, phone, text, and email. This role requires passion for our brand and a desire to foster a competitive sales culture. To be successful in this role, you must have a customer-first approach and thrive in ambiguous and unexpected environments, tackling all challenges with a flexible and solution-oriented mindset. The ideal candidate is self-motivated and results-driven, committed to creating memorable experiences that drive brand loyalty, customer satisfaction, and conversion. Responsibilities Consistently achieve or exceed monthly and quarterly sales targets and other key performance indicators such as demo drive volume, pipeline management, sales conversion, take rate on trade-ins and financial solutions, customer satisfaction and NPS. Ensure customer experience at your location(s) is best-in-class: authentic, engaging, educational and aligned with Rivian's core values and culture. Engage and qualify Rivian customers and identify their unique needs to create personalized and memorable experiences that drive conversion and customer satisfaction. Maintain and share your in-depth knowledge of our products and services, features and benefits, and community stories to effectively guide customers in their decision-making process when considering Rivian. Build and manage a healthy sales pipeline by establishing positive, long-term relationships with customers via high touch, responsive service. Engage and support customers through order confirmation, following up across various stages of the sales process to drive conversion through the funnel and increase customer satisfaction, repeat business and referrals. Host and support a variety of retail activations and experiential events to generate demand and connect with the broader Rivian community. Study and solicit customer feedback to understand and solve for customer pain points and opportunities for continuous improvement. Stay up to date on auto and EV competitive landscape and trends to keep a close pulse on what customers are considering and effectively build value in our products and overcome objections to purchase. Share success strategies, best practices and continuous feedback with teammates to cultivate a culture of learning and winning together built on trust. Perform keyholder location opening and closing duties and ensure policy duties include completing operational checklists, leading team huddles, and writing daily business recaps. Support and motivate fellow team members by providing clear direction and feedback. Resolve customer escalations in the moment and promptly cascade outstanding issues to the appropriate teams. Communicate business trends and data to the leadership team with recommendations regarding areas of opportunity. Pay close attention to customer sentiment and the quality of the service provided; coaching for exceptional performance. Take on additional projects, duties and assignments as required and/or by request from sales leadership. Qualifications Preferred 4+ years experience in Sales, Retail, Hospitality or similar fields highly preferred (top tier, premium brands, direct to consumer models, commission-based environments and/or automotive experience a plus). At least 21 years of age. High School Diploma, GED, or other recognized high school equivalency credential required. Proven track record in a high-velocity sales cycle, from prospecting to closing, in a commission-based environment. Experience succeeding in a face-paced, dynamic start up environment with continuous iteration and changes. Experience using CRM systems (Salesforce preferred). Strong communication and collaboration skills (written and verbal). Ability to work a flexible schedule to support customers on nights, weekends and/or holidays. Ability and willingness to travel as needed to support events, new market launches, etc. Working knowledge of Microsoft Programs (Word, Excel, PowerPoint, Teams) or Google Workspace with the ability to learn new tools quickly. Comfortable operating large, high performance vehicles and conducting demo drives with customers. Ability to work effectively both in a team and independently. Must have a valid driver's license in the state/province of residence that you will be driving/operating a vehicle (or state that you are commuting daily to/from). No drug or alcohol related driving incidents in the last 3 years; No more than 1 serious moving violation in the last 3 years; No driving related suspensions or revocation of Driver License within a 3-5 year period; Will be subject to continuous Motor Vehicle Record (MVR) monitoring. Ability to obtain and maintain local sales licenses if applicable in your state/province. Physical Requirements Willingness to work in various working conditions including being in a full service retail location or service center, including working outdoors and operating vehicles in unpredictable weather conditions. Physical exertion may be required to perform occupational tasks (sitting up to 2 or more hours at a time, standing for up to 8 or more hours a day, walking, bending, kneeling, laying, twisting, carrying, reaching, stretching, pushing, pulling, and lifting up to 50 lbs). Frequent use of hands for purposes of grasping and using tools correctly, entering data, writing communications, or calling customers or internal partners. Strong understanding of written and spoken English. Ability to see, read and interpret documents such as governmental regulations, safety rules, operating and maintenance instructions or schematics. Competencies Energetic, enthusiastic, and engaging customer interaction style. Ability to understand and articulate concepts in the technology and automotive space. Resilience and ability to overcome objections using active listening and critical thinking. Ability to multi-task while providing exceptional quality of work. Ability to work effectively both in a team and independently. Excellent written and verbal language skills in English, additional languages a plus. Ability to learn quickly, thrive in a fast-paced environment and adapt to changing timelines. An obsessive approach to elevating the customer experience and commitment to taking every opportunity to over-deliver when it comes to delighting and interacting with our community. Pay Disclosure The hourly rate for the level IV role is $19.24 to $24.05 for Massachusetts based applicants. This is the lowest to highest hourly rate we in good faith believe we would pay for this role at the time of this posting. An employee's position within the hourly range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, geographic location, shift, and organizational needs. The successful candidate may be eligible for incentive payments per plan terms and conditions We offer a comprehensive package of benefits for full-time and part-time employees, their spouse or domestic partner, and children up to age 26, including but not limited to paid vacation, paid sick leave, and a competitive portfolio of insurance benefits including life, medical, dental, vision, short-term disability insurance, and long-term disability insurance to eligible employees. You may also have the opportunity to participate in Rivian's 401(k) Plan and Employee Stock Purchase Program if you meet certain eligibility requirements. Full-time employee coverage is effective on their first day of employment. Part-time employee coverage is effective the first of the month following 90 days of employment. More information about benefits is available at rivianbenefits.com. You can apply for this role through careers.rivian.com (or through internal-careers-rivian.icims.com if you are a current employee). There is no fixed deadline for this application; applications are accepted on an ongoing basis until the role is filled or the opening is no longer needed. Equal Opportunity Rivian is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, gender, gender expression, gender identity, genetic information or characteristics, physical or mental disability, marital/domestic partner status, age, military/veteran status, medical condition, or any other characteristic protected by law. Rivian is committed to ensuring that our hiring process is accessible for persons with disabilities. If you have a disability or limitation, such as those covered by the Americans with Disabilities Act, that requires accommodations to assist you in the search and application process, please email us at candidateaccommodations@rivian.com. Candidate Data Privacy Rivian may collect, use and disclose your personal information or personal data (within the meaning of the applicable data protection laws) when you apply for employment and/or participate in our recruitment processes ("Candidate Personal Data"). This data includes contact, demographic, communications, educational, professional, employment, social media/website, network/device, recruiting system usage/interaction, security and preference information. Rivian may use your Candidate Personal Data for the purposes of (i) tracking interactions with our recruiting system; (ii) carrying out, analyzing and improving our application and recruitment process, including assessing you and your application and conducting employment, background and reference checks; (iii) establishing an employment relationship or entering into an employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping; (vi) ensuring network and information security and preventing fraud; and (vii) as otherwise required or permitted by applicable law. Rivian may share your Candidate Personal Data with (i) internal personnel who have a need to know such information in order to perform their duties, including individuals on our People Team, Finance, Legal, and the team(s) with the position(s) for which you are applying; (ii) Rivian affiliates; and (iii) Rivian's service providers, including providers of background checks, staffing services, and cloud services. Rivian may transfer or store internationally your Candidate Personal Data, including to or in the United States, Canada, the United Kingdom, and the European Union and in the cloud, and this data may be subject to the laws and accessible to the courts, law enforcement and national security authorities of such jurisdictions. Please note that we are currently not accepting applications from third party application services. Preferred 4+ years experience in Sales, Retail, Hospitality or similar fields highly preferred (top tier, premium brands, direct to consumer models, commission-based environments and/or automotive experience a plus). At least 21 years of age. High School Diploma, GED, or other recognized high school equivalency credential required. Proven track record in a high-velocity sales cycle, from prospecting to closing, in a commission-based environment. Experience succeeding in a face-paced, dynamic start up environment with continuous iteration and changes. Experience using CRM systems (Salesforce preferred). Strong communication and collaboration skills (written and verbal). Ability to work a flexible schedule to support customers on nights, weekends and/or holidays. Ability and willingness to travel as needed to support events, new market launches, etc. Working knowledge of Microsoft Programs (Word, Excel, PowerPoint, Teams) or Google Workspace with the ability to learn new tools quickly. Comfortable operating large, high performance vehicles and conducting demo drives with customers. Ability to work effectively both in a team and independently. Must have a valid driver's license in the state/province of residence that you will be driving/operating a vehicle (or state that you are commuting daily to/from). No drug or alcohol related driving incidents in the last 3 years; No more than 1 serious moving violation in the last 3 years; No driving related suspensions or revocation of Driver License within a 3-5 year period; Will be subject to continuous Motor Vehicle Record (MVR) monitoring. Ability to obtain and maintain local sales licenses if applicable in your state/province. Physical Requirements Willingness to work in various working conditions including being in a full service retail location or service center, including working outdoors and operating vehicles in unpredictable weather conditions. Physical exertion may be required to perform occupational tasks (sitting up to 2 or more hours at a time, standing for up to 8 or more hours a day, walking, bending, kneeling, laying, twisting, carrying, reaching, stretching, pushing, pulling, and lifting up to 50 lbs). Frequent use of hands for purposes of grasping and using tools correctly, entering data, writing communications, or calling customers or internal partners. Strong understanding of written and spoken English. Ability to see, read and interpret documents such as governmental regulations, safety rules, operating and maintenance instructions or schematics. Competencies Energetic, enthusiastic, and engaging customer interaction style. Ability to understand and articulate concepts in the technology and automotive space. Resilience and ability to overcome objections using active listening and critical thinking. Ability to multi-task while providing exceptional quality of work. Ability to work effectively both in a team and independently. Excellent written and verbal language skills in English, additional languages a plus. Ability to learn quickly, thrive in a fast-paced environment and adapt to changing timelines. An obsessive approach to elevating the customer experience and commitment to taking every opportunity to over-deliver when it comes to delighting and interacting with our community. Consistently achieve or exceed monthly and quarterly sales targets and other key performance indicators such as demo drive volume, pipeline management, sales conversion, take rate on trade-ins and financial solutions, customer satisfaction and NPS. Ensure customer experience at your location(s) is best-in-class: authentic, engaging, educational and aligned with Rivian's core values and culture. Engage and qualify Rivian customers and identify their unique needs to create personalized and memorable experiences that drive conversion and customer satisfaction. Maintain and share your in-depth knowledge of our products and services, features and benefits, and community stories to effectively guide customers in their decision-making process when considering Rivian. Build and manage a healthy sales pipeline by establishing positive, long-term relationships with customers via high touch, responsive service. Engage and support customers through order confirmation, following up across various stages of the sales process to drive conversion through the funnel and increase customer satisfaction, repeat business and referrals. Host and support a variety of retail activations and experiential events to generate demand and connect with the broader Rivian community. Study and solicit customer feedback to understand and solve for customer pain points and opportunities for continuous improvement. Stay up to date on auto and EV competitive landscape and trends to keep a close pulse on what customers are considering and effectively build value in our products and overcome objections to purchase. Share success strategies, best practices and continuous feedback with teammates to cultivate a culture of learning and winning together built on trust. Perform keyholder location opening and closing duties and ensure policy duties include completing operational checklists, leading team huddles, and writing daily business recaps. Support and motivate fellow team members by providing clear direction and feedback. Resolve customer escalations in the moment and promptly cascade outstanding issues to the appropriate teams. Communicate business trends and data to the leadership team with recommendations regarding areas of opportunity. Pay close attention to customer sentiment and the quality of the service provided; coaching for exceptional performance. Take on additional projects, duties and assignments as required and/or by request from sales leadership. Read Less

Business Unit: Financial And Valuation Advisory Industry: Transaction Advisory Services Overview Houlihan Lokey, Inc. (NYSE:HLI) is a leading global investment bank recognized for delivering independent strategic and financial advice to corporations, financial sponsors, and governments. With uniquely deep industry expertise, broad international reach, and a partnership approach rooted in trust, the firm provides innovative, integrated solutions across mergers and acquisitions, capital solutions, financial restructuring, and financial and valuation advisory. Our unmatched transaction volumes provide differentiated, data-driven perspectives that help our clients achieve their most critical goals. To learn more about Houlihan Lokey, please visit HL.com. Financial and Valuation Advisory Over the past 50+ years, Houlihan Lokey has established one of the largest worldwide financial and valuation advisory practices. Our transaction expertise and leadership in the field of valuation inspire confidence in the financial executives, boards of directors, special committees, investors, and business owners we serve. In 2025, LSEG ranked us the No. 1 global M Read Less

Contact Center Operator - Boston Children's Service Response Ctr The Call Center Representative provides patient support via phone and software systems and serves as a liaison to other departments regarding patient meal services and other support services. Essential functions and responsibilities of the position may vary by Aramark location based on client requirements and business needs. Hiring for a Full-time Position Compensation Data COMPENSATION: The Hourly rate for this position is $20.56. This is Aramark's good faith and reasonable estimate of the compensation for this position as of the time of posting. BENEFITS: Aramark offers comprehensive benefit programs and services for eligible employees including medical, dental, vision, and work/life resources. Additional benefits may include retirement savings plans like 401(k) and paid days off such as parental leave and disability coverage. Benefits vary by location and are subject to any legal requirements or limitations, employee eligibility status, and where the employee lives and/or works. For more information about Aramark benefits, click here Aramark Careers - Benefits Read Less

The first 3 letters in workplace safety are Y-O-U!TK Elevator is currently seeking an experienced Operations Coordinator- Service in Boston, MA. Responsible for performing all administrative duties associated with processing service contracts, customer changes and supporting the service sales department as needed. ESSENTIAL JOB FUNCTIONS: * Assist with daily dispatching, off-route activity, and scheduling coordination. Participate in daily morning huddles to review sick units, labor availability, and scheduling adjustments. * Generates proposals for code compliance and state work in New Hampshire and Maine. * Coordinates compliance work with service and repair superintendents, managers and technicians. * Oversee orders, records, proposals, permits, testing, and projects for customers, vendors, and TKE employees. * Coordinates with clients on action items, inquiries, and proposals. * Work with State to document compliance and completion of work. * Work with vendors for scheduling and permits * Facilitate accurate and efficient billing information. * Assist with processing certificates of insurance. * occasionally lift and/or move up to 20 pounds. * Performs other duties as assigned. EDUCATION Read Less

Sales Development Representative - Boston Founded in 2018 with co-headquarters in Dublin and Boston, Tines powers some of the world's most important workflows. Our intelligent workflow platform applies AI, automation, and integration with human ingenuity to drive real business results. Tines serves a diverse range of customers, from startups to public companies, including Canva, Databricks, Elastic, Kayak, Intercom, and McKesson. As an integrator across the entire tech stack, Tines is vendor-agnostic integrating with any API-enabled service. This flexibility enables our customers to achieve their highest-priority goals faster. And because Tines is secure and private by design, it's popular with security, IT, engineering, finance, and other security-focused teams. At Tines, we're driven by our values of Simplicity, Speed, and Soundness. We're committed to delivering exceptional customer experiences while fostering a company culture that nurtures individual curiosity, growth, and integrity. We're excited about what's next, and we're looking for others to join us on our journey. This is a hybrid role and will be expected to work out of the Boston, MA office at least 3 days per week. Sales Development Representative At Tines for the North America region, you will be responsible for prospecting outbound leads and sourcing new customer opportunities. This role is one of the first touch points for our new customer prospects and has the opportunity to educate potential clients on how Tines' software can make their business more efficient and effective. Looking for a unique opportunity to build a SaaS company from the ground up? Want to grow into a future revenue leader in a dynamic industry? Then we would welcome the opportunity to speak with you. We're looking for people with a passion for sales who want to jump start their career in software. What you will be doing: Your first 0-6 Months: Learn the Tines product and messaging Learn the tools necessary to be successful: Salesforce.com, Salesloft, LinkedIn Sales Navigator, ZoomInfo, Demandbase, etc. Build relationships with your Account Executive, Solutions Engineer, Marketing, and Field Leadership counterparts Work directly with Account Executives to drive new customer pipeline and crush your pipeline generation targets Identify and qualify new customer leads and opportunities in your market/territory through a mix of email, prospecting, social selling and other tools Create targeted prospect lists and personalize outreach to multiple stakeholders within Tines' key prospect accounts Your next 6-24 Months: Continue to build on your core skills and product/industry knowledge Demonstrate mastery of prospecting and business management by continuously meeting or exceeding your pipeline goals Begin to expand your knowledge of Sales and other revenue function's duties and responsibilities Work with mentors to set goals for yourself to gain consideration for promotion What you bring with you: A self-starter attitude with a track record of hitting and exceeding goals Strong communication skills including both phone and written communication as well as active listening Coachability and a team player mentality An eye for detail, a curious nature and strong planning skills Fluency in the English language Preferred qualifications: Experience: 1-2 years of experience in a business development, sales development, or outbound sales role, preferably in SaaS or a technical product company Technical Understanding: Leverage technical knowledge, such as computer science background, coding bootcamp experience, or relevant certifications, to comprehend and articulate the technical aspects of Tines' automation platform. Product Knowledge: Develop a deep understanding of Tines' no-code automation software and its applications in the security and IT domains. Annual target compensation (salary + commission): $80K + equity Applicants for this opportunity must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. At Tines, we're all about trying new things and taking the leap. If you're second-guessing your application, we hope you'll trust your gut and take the leap too! Applying for a new job isn't always easy, especially if you're thinking of a career pivot but we're big believers in learning and growth here at Tines, so you've nothing to worry about. A variety of experience, perspectives, and voices makes us the company we are. We'd love to hear from you. Tines provides equal employment opportunities to all employees and applicants for employment without regard to sex, race, color, ethnic or social origin, genetic features, language, religion or belief, political or any other opinion, membership of a national minority, property, birth, disability, age or sexual orientation. Read Less

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

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

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

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance. Establish best practices and builds a strong regulatory community across Global Regulatory Affairs spanning device, combination product, quality, clinical, development and manufacturing interfaces. Serve as an influential leader internally and externally, shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions (e.g., US, EU, UK, Japan, China). How you will contribute: Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances. Partners with cross-functional leaders (Regulatory, Development, Clinical, Quality, Safety, Manufacturing, Supply Chain, Market Access, and Medical) to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements for devices and combination products. Ensures line management and key stakeholders are apprised of developments impacting regulatory success (e.g., design changes, nonconformances, clinical evidence, labeling/UDI, post-market signals). Anticipates risks and drives mitigation plans consistent with ISO 14971, design controls, and applicable global regulations. Represents Global Regulatory Affairs in senior-level governance and in interactions with global regulators and notified bodies, including FDA (CDRH/CDER and Office of Combination Products), EMA/Competent Authorities under EU MDR, MHRA, PMDA, and other agencies as applicable. Accountable for ensuring global submissions and lifecycle compliance for devices and combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking under MDR, technical documentation, variations/changes, vigilance). Partners with regional leads, quality, and vendors to ensure compliant, inspection-ready processes and documentation. Leads departmental and cross-functional initiatives to improve regulatory strategy, operational excellence, and quality systems interfaces (e.g., design controls, labeling governance, supplier controls, post-market surveillance, digital/connected device considerations). Influences without authority across R D and Global Regulatory Affairs. Provides regulatory strategy leadership for business development and due diligence activities, including assessment of device/combination product classification, regulatory pathways, technical evidence requirements, and lifecycle obligations. Monitors and anticipates global regulatory trends impacting devices and combination products (e.g., MDR implementation, FDA guidance, standards such as ISO 13485/14971/IEC 62304, cybersecurity expectations), translating insights into proactive regulatory and evidence strategies. Responsible for demonstrating Takeda leadership behaviors. Minimum Requirements/Qualifications: Advanced degree in a scientific, or engineering discipline (e.g., MS, PhD, PharmD) 20+ years of industry experience with 10+ years in Regulatory Affairs and demonstrated leadership in medical devices and/or drug-device combination products. Significant experience leading, reviewing, authoring, or managing regulatory submissions for devices and/or combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation), including major deficiency responses and negotiation of requirements. Strong working knowledge of device and combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance obligations; experience with other regions a plus. Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy. Provides expert guidance on global device/combination regulatory strategy, including technical documentation/Design History File expectations, design controls, human factors/usability, biocompatibility, software and cybersecurity considerations (as applicable), and post-market lifecycle planning. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative Solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $238,000.00 - $374,000.00 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 Read Less

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, Trial Equity Representation based remotely reporting to the Director, Trial Equity Representation. At Takeda, we are transforming the pharmaceutical industry through our R D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: Work with partners and team members to ensure the delivery of global trials with diverse patient populations representative of the anticipated population to be treated with the products in development. Allow study teams to conduct ongoing delivery of trials within timelines that contribute to operational planning and decisions resulting in predictable delivery for achieving R D goals. Support diversity, equity and inclusion tactics for clinical trial programs. Implement diversity, equity and inclusion strategies based on disease demographics and population data. Assist with directing trial level efforts to ensure delivery of diverse participant populations in clinical trials representative of populations anticipated to be treated with the marketed product. Conduct training and awareness programs to educate clinical operations staff on the importance of diversity in clinical trial populations. Provide additional management support for accelerated programs/trials. ACCOUNTABILITIES: Improve the development of the diversity and inclusion tactics at the trial level. Provide oversight and coaching to study teams to ensure diversity of clinical trial populations. Work with the Patient Engagement, Experience Recruitment team to ensure strategies are in place to recruit and retain diverse patient populations with established trial goals. Oversee tracking and measurement of effectiveness and success of diversity strategies at the trial level through the collection and analysis of multiple data sources. Monitor dashboard and metrics to track progress towards meeting trial-level metrics, therapeutic area metrics and company level metrics. Partner and work with the other members of the Clinical Site Start-up Engagement (CSSE) team to meet the trial goals. Be a role model for Takeda's values. Provide perspective, insights, and knowledge to study teams during protocol design and planning. Drive results that help embed diversity inclusion in clinical trial principles into ways of working. Distill complex issues and ideas down to simple comprehensible terms. EDUCATION AND EXPERIENCE: BS degree or international equivalent required ; advanced degree is desirable. 3+ years of experience in clinical operations, investigative site management, patient recruitment, data analytics, and trial optimization within a pharmaceutical company, CRO or other relevant vendor. Experience developing investigative site and patient engagement strategies. Demonstrate and explain unbiased data insights into clinical trials operational planning. Explain data to facilitate decision-making processes. Health care knowledge with a comprehensive understanding of the pharmaceutical industry, health disparities, unmet needs, and under-served patient populations. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $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 Massachusetts - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #LI-Remote Read Less

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions. Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. How you will contribute: With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10+ years of overall biopharmaceutical/device industry experience with 5+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies decisions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies the given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. Read Less

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as Associate Director, Statistics in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: Takeda's mission is to serve patients. This patient focus drives the organization to create the medicines patients need and the innovations that will deliver genuine improvements to their lives. Takeda insists on a high standard for innovation in order to deliver true value to patients, healthcare providers, payers and other stakeholders. The R D Data and Quantitative Sciences organization influences senior leadership and stakeholders to advance Takeda's R D pipeline. Central to Takeda's R D operating model are the pillars of Data Quantitative Sciences, which are leveraged to support the imperative of becoming a data-driven and scientifically and quantitatively disciplined rigorous organization. This focus enhances the speed and success of R D growth and strengthens competitiveness. R D Data Quantitative Sciences encompasses several global functions, including Quantitative Pharmacology and Translational Sciences, Statistics Quantitative Sciences, Programming, Patient Safety Pharmacovigilance, and Strategic Operations The Statistics and Quantitative Sciences (SQS) department integrates data science, analytics, and quantitative methods to enhance efficiency and precision throughout the drug discovery and development lifecycle. It leverages cutting-edge technology, machine learning, AI, and statistical methods to analyze complex datasets, generate predictive models, and provide actionable insights. It collaborates cross-functionally to ensure scientific rigor and compliance with regulatory standards in all decision-making processes. POSITION ACCOUNTABILITIES: Lead delivery for one or more assets at GPT level or specialty area in preclinical, clinical, translational Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R D, and with external vendors Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation Create an internal cross functional and external with vendors sphere of influence in predictable delivery Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: Must have degree in statistics/biostatistics or in other equivalent quantitative sciences along with the following specific credentials: PHD with ~ 5 years experience MS with ~ 8+ years experience Technical Skills: Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics Scientific understanding of drug R D to inform methodological input with product team or in a platform Strong communication skills and ability to translate effectively across functional lines Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs Enable the tactical execution of the SQS and DQS vision and mission Lead and be accountable for asset level strategies being implemented Demonstrate mentorship, matrix or direct management of small team of SQS colleagues Facilitate collaboration cross functionally in GPTs and generally within DQS and R D Create an internal and external sphere of influence in area of expertise This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. LI-JV2 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Lead Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team At Takeda, we are transforming the pharmaceutical industry through our R D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world. Here, you will be a necessary contributor to our inspiring, bold mission. GOALS: Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s): Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda's obligations described in ICH-GCP and Takeda's business objectives. The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the coordination of multiple vendors, or other special assessments. More than one study and/or more than one program may be assigned. ACCOUNTABILITIES: Accountable for planning and operational strategy and execution for assigned clinical trials. Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents. Challenges study team to ensure operational feasibility, inclusive of patient and site burden Validates budget and ensures impacts are adequately addressed. Participates in country and site feasibility/selection process, with a focus on providing country insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy. Challenges study team to ensure timelines meet the needs of the clinical development plan. Ensure new team members and vendors are appropriately onboarded. During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development of the Operational Strategy in preparation for Operational Strategy Review; focus on ensuring accurate assumptions are applied and robust risk management plans are in place. Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are addressed and resolved rapidly. Responsible for study budget planning and management and accountable for external spend related to study execution. Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs. Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted. Specific areas of sponsor oversight include, but are not limited to: Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring Review and endorsement of relevant study plans, as applicable Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR. Ensure studies are inspection ready at all time; may be involved in regulatory inspections by preparing for and/or attending the inspections. Represent the Lead Clinical Study Manager role in functional initiatives or working groups. Help with onboarding and mentoring of new or junior CSMs. May assist the program COPL in his/her role, as required EDUCATION AND EXPERIENCE: BS/BA required preferably in a health-related, life science area or technology-related fields or equivalent combination of education, training and experience. Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) may be considered to supplement experience requirements. 6+ years' experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight. Experience must include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous. Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required. Demonstrated excellence in project/program management and matrix leadership. Excellent communication skills. Excellent teamwork, organizational, interpersonal, and problem-solving skills. Fluent business English (oral and written). TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Massachusetts - Virtual U.S. Base Salary Range: $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 Read Less

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education Competencies: Bachelor's Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4+ years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $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 application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Head of R D Global Capability Centers (GCC) is a senior enterprise leadership role accountable for shaping, establishing, and scaling Takeda's globally integrated, multi-hub R D delivery model. The role serves as the single, cross-R D point of accountability for GCC strategy, operating model design, and execution, and acts as the primary R D interface to the Enterprise Transformation Office and R D Leadership Team during hub establishment and early maturity phases. Operating at an executive level, this leader partners closely with R D functions, Therapeutic Areas, and enterprise stakeholders to ensure that global hubs in Poland and India are established and fully integrated into Takeda R D, delivering sustainable capabilities, talent pipelines, and long-term enterprise value. How you will contribute: Takeda is seeking a senior R D leader to own R D's Global Capability Center (GCC) vision, and lead and coordinate R D GCC activities across the enterprise. This role is accountable for coordinating the establishment and scaling of R D hub locations in Poland and India, aligned to a multi-hub, globally integrated R D development model. The role operates as the single, cross-R D point of accountability for GCC strategy, execution, and integration, and serves as the primary R D interface to the Enterprise Transformation Office and R D Leadership during hub stand-up and early maturity phases. This position reports into the Head of R D Operational Excellence and partners closely with R D functions, Therapeutic Areas, and enterprise stakeholders to ensure that global hubs deliver both near-term value and long-term capability building. This role requires significant cross functional leadership. Strategic Context: This role supports Takeda's evolution toward a globally integrated, multi-hub R D model that: Establishes Cambridge, MA, Poland, and Bangaluru, India as interconnected R D hubs Focus on capability and talent development Enables hybrid Global Program Team (GPT) execution across hubs Requires strong central leadership to coordinate governance, integration, and change management Key Responsibilities: Enterprise R D Leadership: Serve as the R D-wide GCC Lead with accountability for strategy, execution, and evolution Act as primary R D counterpart to the Enterprise Transformation Office and R D Leadership Representing GCC strategy with senior R D and enterprise governance forums GCC Strategy Operating Model: Define the multi-year GCC vision and roadmap Design and implement the multi-hub operating model Ensure alignment with R D functional strategies Hub Establishment Scale-Up (Poland India): Lead R D input into hub stand-up Partner with enterprise teams on infrastructure, talent, and change Enable phased capability scaling Cross-Functional Coordination: Coordinate across R D functions and Therapeutic Areas Resolve cross-functional dependencies Ensure clear accountability Talent, Capability Culture: Shape leadership and talent models Support sustainable talent pipelines Promote Takeda values Minimum Requirements/Qualifications: Required: 15+ years leadership experience in life sciences R D Experience across multiple R D functions Large-scale transformation leadership Global Capability Center operating experience Preferred: GCC or global delivery hub experience Hybrid operating model exposure Digital, data, or AI-enabled R D transformation Advanced degree Travel: 30% travel required 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: $259,000.00 - $407,000.00 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

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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Amergis Healthcare Staffing is partnered with a much-respected facility in Boston, MA who is currently seeking a qualified CT Technologist to assist them on a contractual basis. Details of the position include: Position: CT Technologist Location: Boston, MA Facility Type: Hospital setting Start: ASAP Duration: 13 weeks- Likelihood of extension Hours: 36 or 40 Shifts: Days, evenings or overnights depending on preference Requirements 1+ year of experience MA State License can be pending AART I hope to connect soon! If the job specifications don't match your preferences, please feel free to get in touch and share more about what you're looking for. Travis O'Brien | Allied Healthcare Recruiter Call or Text 781-400-7119 | E-mail Trobrien@amergis.com Benefits At Amergis, we firmly believe that our employees are the heartbeat of our organization and we are happy to offer the following benefits: Competitive pay Read Less

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

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&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 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 Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions for high-impact oncology programs.How you will contribute:Oversee as well as execute all regulatory activities of one or multiple complex projects in development and/or supports regulatory activities for assigned projects.Serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility.May lead the global regulatory sub-team (GRT) for assigned projects.May serve as global and/or regional regulatory lead as a member of a GRTPrimary FDA contact for projects of responsibility.Accountable for all US FDA submissions and approvals of project(s) 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.Ensure 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.Participate with influence in or leads departmental and cross-functional task-forces and initiatives.May partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.Develop/author and execute global regulatory strategies for complex strategies. May oversee execution.Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.Responsible for demonstrating Takeda leadership behaviors.May lead regulatory assessment as part of due diligence teams for licensing opportunities.Identify and propose solutions to management for any resource gaps for assigned project(s). May present to senior management as requested.Participate with influence in or leads departmental and cross-functional task-forces and initiatives.Minimum Requirements/Qualifications:Bachelor's Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred.A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience.Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a must. Knowledge of EU, Canada, ROW is a plus.Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.Demonstrate strong skills with increasing independence in the area of regulatory strategy.Strong ability to work well with others and within global teams; and acceptable at communicating with senior leadership.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.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-HybridLI-AA1Takeda Compensation and Benefits SummaryWe understand compensation is an important factoras you consider the next step in your career. We are committed to equitablepay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MAU.S. Base Salary Range:$177,000.00 - $278,080.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Read Less

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAt Takeda, we are a forward-looking, world-class R communicate priorities, risks, and trade-offs with transparency at project and governance levels.Collaborate with external CROs, technology vendors, and academic partners when appropriate, ensuring consistent quality standards and strategic alignment with internal capabilities.Quality, Compliance apply data-driven methodologies (e.g., Lean, Six Sigma, DoE) to drive continuous improvement.Oversee investigations and CAPA implementation related to assay performance, automation reliability, or data issues. Education and Experience:Expected: Ph.D. in Pharmaceutical Sciences, Drug Metabolism, Biochemistry, Pharmacology, or related field with 10+ years of relevant industry experience; or M.S. with 16+ years; or B.S. with 18+ years in pharmaceutical/biotech R Read Less