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Takeda Pharmaceuticals U.S.A., Inc. jobs in Boston, MA - 662 jobs

  • Global Neuroscience Drug Discovery Lead

    Takeda 4.7company rating

    Takeda job in Boston, MA

    A global biopharmaceutical company in Boston is looking for a Global Therapeutic Research Lead to drive critical drug discovery projects within the Neuroscience Drug Discovery Unit. This role requires an advanced degree and extensive industry experience, emphasizing leadership in drug discovery from target identification to clinical development. Ideal candidates will have a proven track record in managing strategic projects and collaborating effectively across teams to foster innovation and excellence. #J-18808-Ljbffr
    $112k-207k yearly est. 2d ago
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  • Global Immunology Research Lead: Top Discovery Projects

    Takeda 4.7company rating

    Takeda job in Boston, MA

    A global biopharmaceutical company in Boston seeks a Global Therapeutic Research Lead to manage critical drug discovery projects within gastroenterology and inflammation. You'll leverage extensive experience in drug discovery to lead project strategies, provide mentorship to teams, and drive innovations. Candidates must have a PhD and at least 15 years of industry experience. The role is hybrid with competitive compensation and comprehensive benefits. #J-18808-Ljbffr
    $93k-150k yearly est. 2d ago
  • Global Brand Leader, Oral PCSK9i

    Astrazeneca 4.6company rating

    Boston, MA job

    A top pharmaceutical company in Boston is seeking a Global Commercial Head for the oral PCSK9i asset. This pivotal role involves developing and executing a comprehensive global marketing strategy, leading brand planning, and leveraging customer insights to inform product strategies. The ideal candidate will have over 15 years of experience in pharmaceutical commercialization, with a strong background in cardiovascular, renal, and metabolic functions. Exceptional leadership and collaboration skills, alongside a BA/BS in related fields, are essential for this role. #J-18808-Ljbffr
    $109k-142k yearly est. 3d ago
  • Global Safety Director: Risk Strategy & Leadership

    Astrazeneca 4.6company rating

    Boston, MA job

    A global biopharmaceutical company based in Boston seeks a Director, Safety Scientist to lead risk management and mentor junior scientists. Responsibilities include managing safety evaluations, preparing regulatory documents, and representing global safety at inspections. Ideal candidates have advanced degrees and over 7 years in drug safety, with experience in risk management regulations. Offering competitive salary, incentives, and diverse benefits. #J-18808-Ljbffr
    $133k-180k yearly est. 2d ago
  • Global Head of mRNA Research & Biomarkers

    Sanofi 4.3company rating

    Waltham, MA job

    A global biopharmaceutical company is seeking a Global Head of Research and Biomarkers in Waltham, MA. This executive role involves leading R&D for mRNA and LNP, strategizing biomarker optimization, and managing teams of scientists. Ideal candidates will have a PhD and over 15 years of experience in the biotech industry, alongside skills in molecular biology and team leadership. This is an opportunity to advance next-gen scientific innovations in vaccines. #J-18808-Ljbffr
    $69k-97k yearly est. 2d ago
  • Global Head, Design & Delivery, Pharma Digital

    Takeda 4.7company rating

    Takeda job in Boston, MA

    A global biopharmaceutical company is looking for a Head of Design & Delivery in Boston to lead the digital product strategy across its Pharmaceutical Science portfolio. The role involves managing a global team and overseeing the delivery of innovative digital solutions while driving operational excellence in CMC processes. Candidates should possess extensive experience in pharmaceutical R&D technology and strong leadership skills. #J-18808-Ljbffr
    $97k-160k yearly est. 4d ago
  • Executive Director, Corporate Governance & Legal

    Takeda 4.7company rating

    Takeda job in Boston, MA

    A biopharmaceutical company is seeking a Head of Corporate Governance Legal in Boston, MA. This pivotal role involves overseeing corporate governance, advising the executive team on legal compliance, and managing board meetings. Candidates should have a Juris Doctor (JD) and over 12 years of relevant experience in corporate governance, preferably within the pharmaceutical or biotech sector. Strong leadership and communication skills are essential. This full-time role offers a comprehensive benefits package including competitive salary and healthcare options. #J-18808-Ljbffr
    $107k-194k yearly est. 5d ago
  • Oncology Learning & Development Lead - Patient Access & Value

    Takeda 4.7company rating

    Takeda job in Boston, MA

    A leading pharmaceutical company is seeking an Associate Director to enhance capabilities within the oncology team. You will lead training initiatives, develop comprehensive learning programs, and drive field performance. The ideal candidate has 8+ years of experience in pharmaceutical sales or account management, specifically in oncology, with a strong focus on leadership and strategy. The position offers a base salary range of $153,600 - $241,340 and supports a hybrid work model. #J-18808-Ljbffr
    $153.6k-241.3k yearly 2d ago
  • Head of Corporate Governance Legal

    Takeda 4.7company rating

    Takeda job in Boston, MA

    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 Corporate Governance Legal is a pivotal leadership role responsible for shaping and guiding the company's legal strategy for corporate governance. This position oversees the legal support provided to the Board of Directors, manages board and committee meetings, statutory records, risk, and relationships with external counsel. Serving as a trusted advisor to the Global General Counsel and executive leadership, the Head of Corporate Governance Legal ensures regulatory compliance and integrates legal expertise with business strategy to drive sustainable growth and operational excellence. How you will contribute: Provide end-to-end oversight of corporate entity management and global corporate governance frameworks. Act as the primary Legal Business Partner to finance, ESG, and investor relations teams. Advise the executive team on compliance with applicable laws and regulations, proactively monitor regulatory developments, and counsel on the legal implications of strategic business decisions. Deliver expert guidance on a broad spectrum of corporate governance matters, including board evaluations, executive compensation, and shareholder communications. Develop, implement, and oversee the system of rules, practices, and processes that direct and control the company, ensuring accountability, transparency, and fairness in all governance activities. Conduct sophisticated legal analyses of complex and high-risk issues, providing counsel at all organizational levels, including the Board of Directors, CEO, and executive team members. Demonstrate leadership in legal innovation and cross‑functional initiatives, driving improvements beyond traditional legal boundaries and fostering a culture of agility and technological advancement. Champion continual improvement in ways of working, leveraging technology to enhance efficiency and effectiveness across the organization. Exhibit an enterprise mindset, applying critical thinking to issues with significant business impact and leading cross‑functional, innovative initiatives. Preferred Qualifications: Juris Doctor (JD) degree and active legal license in the relevant region. 12+ years of experience in corporate governance, including board composition, responsibilities, and duties, with a focus on the pharmaceutical or biotech industry. Professional legal training from a highly regarded law firm, with significant post‑qualification legal experience. Demonstrated in‑house legal experience in the pharmaceutical or biotech sector, in roles of increasing responsibility. Proven personnel management experience, including leading teams of attorneys and legal professionals at all levels. Business‑level fluency in English (spoken and written). Strong capability in managing complexity and ambiguity, with excellent interpersonal and relationship‑building skills. Business‑focused mindset with a deep understanding of business strategies, financial matters, and the ability to align legal priorities with business risk. Outstanding communication and presentation skills, with the ability to influence and build consensus across global and cross‑functional teams. 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: $281,400.00 - $442,200.00 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 #J-18808-Ljbffr
    $55k-76k yearly est. 5d ago
  • Global Immunology Cell Therapy Commercial Lead

    Astrazeneca 4.6company rating

    Boston, MA job

    A leading biopharmaceutical company is seeking a Global Commercial Director for Immunology Cell Therapy based in Boston. In this role, you will develop and implement commercial strategies and lead initiatives for launching new therapies in the market. Ideal candidates will have over 10 years of experience in pharmaceutical development and a strong understanding of commercial strategies. This position offers a salary range of $229,303 to $343,955 annually, along with various benefits, including health coverage and retirement plans. #J-18808-Ljbffr
    $229.3k-344k yearly 3d ago
  • Director/Associate Director - R&D Discovery Vector Engineering

    Astrazeneca 4.6company rating

    Boston, MA job

    We are building an integrated discovery-to-development engine that connects vector innovation with translational impact. Join us to shape platform strategy, deliver differentiated candidates, and help patients faster. As a proud new member of the AstraZeneca group, Esobiotec continues to set new standards in pioneering biotechnological research. With a shared vision to transform the future of medicine, our partnership uses AstraZeneca's global reach and rich heritage in scientific innovation, amplifying Esobiotec's unique culture of creativity and breakthrough advances in cell-based therapies and immunology. At Esobiotec, now backed by the resources and expertise of one of the world's leading biopharmaceutical companies, you'll find a dynamic, collaborative environment where scientific passion drives real-world impact. Be part of a team where your work will contribute to shaping the next generation of life-changing treatments and help us push the boundaries of science to improve patients' lives worldwide. What You'll Do Discovery Strategy: Support and evolve the discovery strategy for novel LVVs aligned to target product profiles, manufacturability, and clinical use cases. Vector Engineering Leadership: Drive hypothesis-driven engineering from concept to preclinical candidate selection, including envelope/pseudotype, regulatory elements, payload design, and transduction specificity. Innovation Sourcing: Source and prioritize new concepts from literature, IP, conferences, and internal takeaways; establish efficient triage and proof-of-concept workflows. Screening Platforms: Build and scale in vitro and in vivo screening platforms and assays to characterize potency and safety, implementing robust data and analytics workflows. Product Translation: Translate indication/product requirements into vector design criteria; collaborate with biological engineering, CAR/TCR discovery, nonclinical, safety, and clinical to de-risk translation. Developability & CMC: Integrated developability and CMC considerations early with in development to ensure scalability, yield, purity, and stability. Rigor & Decision-Making: Establish experimental rigor, statistical standards, and clear go/no-go criteria to enable reproducible, high-quality decisions. External Leadership: Identify, negotiate, and manage external collaborations and CROs; assess BD and licensing opportunities for vector technologies. IP & FTO: Drive invention disclosures and FTO assessments; contribute to patent drafting and defence for vector innovations. Team Building: Recruit, mentor, and develop discovery scientists; foster a culture of scientific excellence, product focus, urgency, and accountability. Program Ownership: Manage budgets, resources, and timelines across programs/platforms with transparent portfolio reporting and prioritization. Compliance & Representation: Ensure biosafety and ethical research compliance; represent the function in technical reviews, governance, and external forums, raising risks and securing decisions. What You'll Bring Education: PhD in molecular biology, virology, bioengineering, or related field (or equivalent experience), with postdoctoral or advanced industry training. Experience: 8+ years (Associate Director) or 12+ years (Director) in gene therapy R&D focused on viral vector engineering, preferably LVV. Technical Track Record: Demonstrated success designing, building, and optimizing viral vectors; LVV expertise strongly preferred (AAV or related systems a plus). Product Approach: Clear history of linking vector design to therapeutic product needs, clinical requirements, and manufacturability. CMC Collaboration: Proven partnership with process development/CMC across upstream/downstream production, release testing, and scalability. Leadership: Experience leading small-to-medium discovery teams and matrixed initiatives to timely, high-quality outcomes. Innovation & IP: Evidence of innovation via publications, patents, or internal inventions; facility with FTO analyses and IP strategy. Data Fluency: Proficiency with statistical design and analysis, data visualization, and collaboration with computational teams, including DoE and high-throughput screening. Attributes: Product-focused, decisive, rigorous; thrives in ambiguity while maintaining quality, compliance, and speed. So, what is next: Ready to make an impact? Apply now to join our mission-driven team ! Welcome with your application, in English, at the latest by the 23rd of January 2026 To find out more: Company site: ************************** Group site: **************************** Our social media, Follow us on LinkedIn: Esobiotec and AstraZeneca Inclusion & Diversity: *************************************************** Career site: ******************************** Date Posted 09-Jan-2026 Closing Date 22-Jan-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
    $151k-209k yearly est. 2d ago
  • Director of AI for Large-Molecule Biologics Discovery

    Takeda 4.7company rating

    Takeda job in Boston, MA

    A leading biopharmaceutical company in Boston seeks a Research Scientific Director to spearhead AI/ML-enabled biologics discovery. This role drives the application of AI across drug development and demands a PhD with extensive experience in computational biology and machine learning. The successful candidate will lead strategy development, ensure scientific excellence, and foster an innovative team culture. The position offers a competitive salary, hybrid work options, and robust benefits. #J-18808-Ljbffr
    $87k-124k yearly est. 3d ago
  • Summer 2026 Intern - Immunology New Product Launch Team

    Sanofi Group 4.3company rating

    Cambridge, MA job

    **Job Title:** Summer 2026 Intern - Immunology New Product Launch Team **About the Job** Sanofi is committed to becoming a leader in immunology with over 10 mid and late-stage clinical assets being studied across several immunological disease areas. The New Product Launch team was recently created to support the early commercial planning for this promising pipeline and to help prepare the company and the market for these new, potential treatment options for patients suffering from immunological diseases in the fields of dermatology, respiratory, rheumatology and gastroenterology. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities:** The New Product Launch (NPL) Summer Intern will report to a Senior Director within the NPL team to assist with one or more of the following projects: + Work with the global brand teams and NPL commercial team to support the development of a preliminary **US Brand Plan** for any of our late-stage clinical assets, including rilzabrutinib and duvakitug + Complete a **competitor analysis** within at least one of the following therapeutic areas: asthma / chronic spontaneous urticaria (CSU) / IgG4-related disease (IgG4-RD) / ulcerative colitis / Crohn's Disease to evaluate and summarize current treatments and existing competitors already in the space, therapies in development, and available resources and patient support programs + Support **market access assessment** and early forecasting efforts to scenario plan various launch strategies + Participate in **market research projects** and help identify any insights gaps for future planning **About You** **Basic Qualifications:** + Currently enrolled and pursuing an MBA at an accredited college or university with the expectation that you will complete your current degree in the Spring of 2027 + Must have completed the first year of your MBAprogram prior to the summer internship + Must be enrolled in school the throughout the full duration of the internship with Sanofi + Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship + **Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship** **Preferred Qualifications:** + Desire to serve patients, passion for the patient + Excellent communication skills, interpersonally savvy, ability to collaborate across boundaries + Strong analytical skills, ability to package and present strategic insights and learning + Highly organized with the ability to effectively manage multiple projects and priorities **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. + Exposure to cutting-edge technologies and research methodologies. + Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SG \#LI-GZ \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
    $73k-100k yearly est. 21d ago
  • Associate Director, Polycythemia Vera (PV) Marketing

    Takeda 4.7company rating

    Takeda job in Boston, MA

    Job Description Associate Director, Polycythemia Vera (PV) Marketing Takeda Pharmaceutical Cambridge, MA The Associate Director, Patient Marketing, PV will be a champion of Takeda's culture and values while developing and delivering the patient marketing strategic plan for a new product launch. This role will shape and activate compelling Direct‑to‑patient (DTP) campaigns, specifically driving patient marketing initiatives that build awareness, deepen engagement, and support adherence across in‑office and digital ecosystems. The ideal candidate combines strong consumer/patient marketing expertise with a mindset of curiosity and adaptability, proactively embracing AI tools to drive both efficiency and innovation. This position will report to the Senior Director, Head of PV Marketing. How you will contribute: Develop and deliver the end to end patient marketing strategy. Own the creation and implementation of patient‑centric campaigns and messaging that are highly strategic and powerful across all channels. Develop full suite of core patient education materials, tools & resources (e.g., patient brochure, brand videos, doctor discussion guide, and in‑office promotional assets, etc.). Ensure that all consumer campaigns and messages (branded & unbranded) are seamlessly designed and are in alignment with the overall brand strategy as well as HCP brand initiatives. Support the development of TV/Connected TV advertising and partner closely with the Omnichannel Marketing team to ensure pull‑through of campaign and brand messages across digital channels. Contribute to identifying critical moments and barriers in the patient journey and design content and programs to overcome these barriers. Support the development of branding guidelines and core claims documentation to support consistency and excellence in execution across all channels. Leverage insights from patient ad boards and engage with advocacy groups to incorporate real patient perspectives into all marketing and campaign initiatives. Partner with Insights & Analytics to leverage patient insights across market research and analytics initiatives. Evaluate performance through campaign measurement frameworks and optimize marketing tactics based on marketing analytics, ROI, and other market research insights and analytics. Required: Minimum BS/BA degree. 5+ years of consumer/patient marketing experience; minimum 3+ years within the pharmaceutical industry. Experience in consumer marketing strategy and tactic planning with the ability to communicate ideas to internal partners and external agencies. Consumer marketing experience in media, including digital marketing. Experience leading cross‑functional and agency teams. Strong strategic, analytical, and communication skills with the ability to manage and influence innovative consumer projects through a matrixed organization. Ability to manage multiple priorities, processes, timelines, and expectations of multiple stakeholder groups. Proven track record of influencing, aligning, and inspiring cross‑functional stakeholders at all levels, building trust and cultivating strong relationships to achieve shared goals. Results‑driven mindset with a high level of ownership, urgency, and resilience, consistently delivering on commitments while navigating obstacles and evolving business needs. Demonstrated ability to use data, insights, and structured analysis to inform decisions, challenge assumptions, and recommend evidence‑based actions. A courageous leader who drives change with clarity and conviction, even in the face of ambiguity, resistance, or conflicting priorities. Desired: MBA. Commercial pharma experience in the rare disease or oncology space, including an in‑depth understanding of the disease state/therapeutic area, treatment paradigms, and future trends. New product launch experience. Deep understanding of how to create an impactful omni‑channel ecosystem. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary For Location: Boston, MA U.S. Base Salary Range: $153,600.00 - $241,340.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short‑term and/ or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes #J-18808-Ljbffr
    $153.6k-241.3k yearly 2d ago
  • Biostatistics Evidence Generation & Decision Sciences (EGDS)- Summer 2026 Intern

    Sanofi 4.3company rating

    Cambridge, MA job

    About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our B&P Neurology team as a Data Analyst and you'll lead one or several late phase studies, or lead an indication for a complex compound, under supervision of statistical project leader and/or team leader. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: * Contribute to the design and analysis of both early- and late-phase clinical trials by applying advanced statistical methods and data analysis techniques. * Support the development, evaluation, and implementation of innovative statistical methodologies to address complex problems in clinical research. * Work collaboratively under the guidance and mentorship of senior-level statisticians, gaining hands-on experience in study planning, data interpretation, and the preparation of statistical reports and publications. About You Basic Qualifications: * Currently enrolled and pursuing PhD in Statistics or Biostatistics at an accredited college or university * Candidates must have completed at least two years of graduate coursework and be working on a dissertation toward a PhD in Statistics or Biostatistics * Experience with SAS and R * Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship * Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship Preferred Qualifications: * Effective oral and written communication skills * Experience with python is a plus Why Choose Us? * Bring the miracles of science to life alongside a supportive, future-focused team. * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. * Exposure to cutting-edge technologies and research methodologies * Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
    $39k-46k yearly est. Auto-Apply 57d ago
  • Senior Environmental, Health & Safety Specialist II

    Takeda Pharmaceuticals 4.7company rating

    Takeda Pharmaceuticals job in Lexington, MA

    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:** This is a key leadership opportunity for an experienced EHS professional ready to make a visible impact in a cutting-edge biopharmaceutical manufacturing environment. The Senior EHS Specialist II serves as a strategic EHS leader and technical expert partnering closely with manufacturing, laboratory, warehouse, and engineering teams to drive a proactive safety culture and ensure compliance excellence. This position is ideal for an EHS professional who thrives in a collaborative environment, enjoys influencing without direct authority, and is motivated by solving complex problems, leading projects, and shaping the site's safety and sustainability journey. **How you will contribute:** + **Be a Site Safety Leader:** Partner with manufacturing and laboratory leaders to embed EHS into daily operations and build a culture of care, ownership, and accountability. + **Lead Core EHS Programs:** Own high-impact programs such as Machine Guarding, LOTO, Confined Space, and Fall Protection. Develop and implement improvements that enhance compliance and reduce risk. + **Influence & Coach:** Serve as a trusted EHS advisor for supervisors, engineers, and technicians. Coach others to identify hazards and implement sustainable solutions. + **Project Leadership:** Act as EHS lead for large capital and engineering projects-ensuring safe design, construction, and startup. + **Incident Prevention & Investigation:** Facilitate incident investigations with a focus on learning, root cause analysis, and continuous improvement. + **Data-Driven Improvements:** Analyze EHS data, identify trends, and communicate performance insights to leadership for informed decision-making. + **Engage the Workforce:** Lead site safety committees, mentor EHS champions, and partner with cross-functional teams to strengthen Takeda's high-performance safety culture. **Minimum Requirements/Qualifications:** + 10+ years' experience in the EHS field with a minimum of 3 years in a high pace/high volume manufacturing environment. + BS/BA required in technical discipline: engineering, safety, industrial hygiene, environmental studies, life science or similar field. + Professional certification (CSP, CIH, CHMM, etc.) and/or master's degree in a related field, preferred. + Experience with ISO 14001, 45001 management systems, LEAN, Six Sigma methodology, preferred. + Experience supporting technology transfers, process scale ups, and process hazard analysis, preferred. **Additional Considerations:** + This role is based in Lexington, MA with occasional travel to nearby sites. + Work may include cleanroom gowning and PPE requirements, and occasional off-hour support for projects or emergencies. + Ability to operate a car (valid driver's license) and travel via air, rail or other means of passenger conveyance. + May involve occasional work in a cold, hot, high noise, at heights, or wet environment. + Must be able to crouch, climb, lift, push, pull and carry up to 25 lbs. and remain standing or walking for extended periods. + In general, the position requires a combination of sedentary work and walking around observing conditions. **More about us:** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - MA - Lexington - BIO OPS **U.S. Base Salary Range:** $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - MA - Lexington - BIO OPS **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.
    $57k-80k yearly est. 60d+ ago
  • Pharmaceutical Sales Specialist - R& I Primary Care, Worcester, MA

    Astrazeneca 4.6company rating

    Worcester, MA job

    Pharmaceutical Sales Specialist - R& I Primary Care- Worcester, MA At AstraZeneca, we turn ideas into life-changing medicines. Working here means thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. At AstraZeneca, we are taking bold action on climate because we recognize the connection between healthy people and a healthy planet. As part of our flagship Ambition Zero Carbon program, we have committed to a fully electric vehicle (EV) fleet by the end of 2025, which means that all our drivers will be assigned an EV. As a Pharmaceutical Sales Specialist for the Primary Care Team, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives! Accountabilities • Develop and demonstrate knowledge of clinical disease states and treatment guidelines. • Effectively communicate product information to healthcare professionals. • Execute call plans and Brand Strategy by translating data to actionable insights. • Adapt to and demonstrate a thorough understanding of AZ Selling Model. • Analyze data and trends to build insightful and actionable business plans for your assigned sales territory. • Build relationships and credibility with Primary Care healthcare professionals to effectively position products by establishing unmet needs, clinical differentiation, and fair balance of our Brands. • Leverage multiple channels including digital platforms and face-to-face engagements to drive meaningful customer interactions. • Open to receiving guidance and seek insights for growth and development. Essential Skills/Experience • Bachelor's Degree • 0 - 2+ years of demonstrated Sales or B2B, or Commercial experience • A valid driver's license and safe driving record Essential Skills and Capabilities • Customer Focus: Strong customer relationship management skills with the ability to understand and address customer needs. • Business Acumen: Ability to analyze and interpret complex data to develop strategic sales plans. • Technical Aptitude: Proficiency in using digital tools and platforms to engage with healthcare professionals. • Adaptability: Flexibility and adaptability to changing market conditions and customer needs. • Collaborative: Ability to work effectively in a team environment and collaborate with cross-functional teams. Desirable Skills/Experience • Experience selling to general practitioners (GPs) and primary care centers • In-depth understanding of the healthcare industry and primary care operations At AstraZeneca, we are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear. We shape the future by spotting scientifically-led commercial opportunities and acting now to operationalize and scale them. Driven by the solutions we bring to the healthcare ecosystem, we make an impact at every step of the patient journey, improving their experience and outcomes. Our team thrives on energy and pace, constantly thinking big to answer new challenges. We lead Commercial to provide solutions that a difference, improving our patients' experience and health outcomes. Join us in making a difference in patients' lives - apply today! Date Posted 27-Jan-2026 Closing Date 30-Mar-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
    $110k-180k yearly est. Auto-Apply 2d ago
  • Rebate Associate (Manager Level), Commercial Contracts, US Oncology

    Takeda Pharmaceuticals 4.7company rating

    Takeda Pharmaceuticals job in Boston, MA

    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:** As a member of Takeda Oncology your work will contribute to our bold, inspiring vision: We aspire to cure cancer. Here, you'll build a career grounded in purpose and be empowered to deliver your best. As part of the Patient Value and Access team, you will report to the Contracting Operations Lead and work with key stakeholders. + Perform calculations and generate payments in compliance with executed reimbursement Agreements and maintain all assigned account responsibilities. + Assist in the identification and development of information and process requirements. Consult with managers and key stakeholders to make well-informed decisions, drive process improvement and other initiatives. Provide support for data governance, business process management, and assist in the performance and maintenance of controls, data quality, and accuracy. + Understand business and operational strategies and processes, respond to data requests with appropriate information and analysis. Respond to routine business, systems, and data questions, and assist the team with problem resolution. Assist as needed with routine variance analysis to ensure data completeness and payment accuracy. Conduct research and provide training and guidance as needed. + Provide support for the management and coordination of data and information resources. Maintain an inventory of policy, procedure, training, and other documentation. Support the development of standard reporting and other metrics as required. Support all compliance and audit reviews. + Coordinate resources to support for cross-functional projects and activities. **How you will contribute:** + Perform all the functions required for the management and administration of assigned accounts. Ensures all pertinent contract attributes are properly translated into the correct contract set-up in the rebate payment system. Ensures the accuracy, integrity, and timeliness of all payments for Commercial and Medicare Part D contracted customers, including rebates, fees and chargebacks. This process includes the interpretation and translation of contract language, ensuring formulary/benefit compliance, data validation and rebate calculations. Adhere to all audit requirements and any/all reporting regulations as defined within Takeda's policies and guidelines related to rebate processing. + Gain a thorough understanding of contract terms and requirements and respond to non-routine questions and data problems. Coordinate with internal teams to bring all issues to a satisfactory resolution. + Gather Payer claim level data files, reconcile Payer invoices and perform detailed payment analysis to ensure contract compliance and rebate payment accuracy. GPO roster reconciliation, GPO sales volume reconciliation, run superlist performance reports, and calculate rebates. Maintain trading partners and process rebates and fees within ModelN FLEX revenue management system for both Payer and GPO contracts. Support data requests from US OBU Patient Value & Access field team, Distribution, Data Stewards, and IT, as well as external parties including Payers and GPOs. + Supports all Commercial and Medicare Part D internal/external audits by preparing and providing the necessary documentation to Director, Commercial Contracting Operations + Assists with the implementation of system and/or process improvements to develop more efficient business processes. Provide production support testing of new system enhancements, defects or new programs. Performs all system user acceptance testing for any systems that support the rebate payment process. This also includes working with IT on updating test scripts. + Assists Commercial Contracting Managers with updating rebate training manual and other supporting materials (i.e., quality control checklists). **Minimum Qualifications/Requirements:** + Bachelor's degree or 4 years contracts and pricing experience required. + 2+ years of rebate processing experience in the pharmaceutical industry required. + ModelN/Flex Revenue Manager experience in contract implementation and maintenance preferred. + Experience with various commercial contracting price protection methodologies preferred. + Ability to think through how decisions will impact Takeda, customers and stakeholders prior to execution. + Strong critical thinking and problem solving skills. + Strong verbal and written communication skills. + Must demonstrate excellent organization and time-management skills. + Ability to handle multiple projects and tasks in a matrix environment. **More about us:** At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy. **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** Boston, MA **U.S. Base Salary Range:** $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** 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.
    $111.8k-175.7k yearly 60d+ ago
  • Summer 2026 Intern - Immunology New Product Launch Team

    Sanofi Us 4.3company rating

    Cambridge, MA job

    About the Job Sanofi is committed to becoming a leader in immunology with over 10 mid and late-stage clinical assets being studied across several immunological disease areas. The New Product Launch team was recently created to support the early commercial planning for this promising pipeline and to help prepare the company and the market for these new, potential treatment options for patients suffering from immunological diseases in the fields of dermatology, respiratory, rheumatology and gastroenterology. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: The New Product Launch (NPL) Summer Intern will report to a Senior Director within the NPL team to assist with one or more of the following projects: Work with the global brand teams and NPL commercial team to support the development of a preliminary US Brand Plan for any of our late-stage clinical assets, including rilzabrutinib and duvakitug Complete a competitor analysis within at least one of the following therapeutic areas: asthma / chronic spontaneous urticaria (CSU) / IgG4-related disease (IgG4-RD) / ulcerative colitis / Crohn's Disease to evaluate and summarize current treatments and existing competitors already in the space, therapies in development, and available resources and patient support programs Support market access assessment and early forecasting efforts to scenario plan various launch strategies Participate in market research projects and help identify any insights gaps for future planning About You Basic Qualifications: Currently enrolled and pursuing an MBA at an accredited college or university with the expectation that you will complete your current degree in the Spring of 2027 Must have completed the first year of your MBA program prior to the summer internship Must be enrolled in school the throughout the full duration of the internship with Sanofi Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship Preferred Qualifications: Desire to serve patients, passion for the patient Excellent communication skills, interpersonally savvy, ability to collaborate across boundaries Strong analytical skills, ability to package and present strategic insights and learning Highly organized with the ability to effectively manage multiple projects and priorities Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Exposure to cutting-edge technologies and research methodologies. Networking opportunities within Sanofi and the broader biotech community. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
    $88k-125k yearly est. Auto-Apply 22d ago
  • Staff Device Engineer

    Takeda Pharmaceuticals 4.7company rating

    Takeda Pharmaceuticals job in Lexington, MA

    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** **Primary** **Role:** The Staff Device Engineer will lead technical efforts for combination products and drug delivery device projects with limited oversight. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners. This role supports as well a team of device engineers responsible for all the technical aspects of life cycle management of commercialized Combination Products, Medical Devices and pre-filled syringe among others. This role works with cross functional team to support lifecycle management of commercial combination product. The Staff Device Engineer has extensive experience in medical devices for drug delivery including combination products, solid understanding of polymeric medical device manufacturing processes via molding and assembly, and solid knowledge of global standards for the combination products. This key technical role is responsible for change controls, manufacturing process validation, device product complaints, regular review of DHF, and post-market surveillance as related to on-market products. This role interacts with external CLO and CMO and vendors, works closely with drug product, quality, regulatory, program leadership, etc. and establish strategic working relationships. **Responsibilities:** + Plans and coordinates work with departmental and cross functional peers (within and outside Pharm Sci) with an understanding of project timelines/deliverables and define risks and recommend contingency plans as required. + Evaluates impact of decisions across CMC functions. + Makes significant independent contributions to complex pipeline or functional area project. May significantly contribute to more than one project within functional area. + Independently designs, executes and reports results. Proactively analyses manufacturing issues and coordinates potential solutions with the CMC team. Assists in the technical aspects of negotiation with vendors. + Coordinates support of specific technical issues related to projects + May proactively address issues during or resulting from manufacturing. + Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations. + Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. + Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. + Lead or assist in deviation, complaint and failure investigations. **Education and Experience** **Requirements:** + Bachelor's degree and 8+ years relevant industry experience **or** master's degree and 6+ years relevant industry experience, **or** PhD and 0+ years in the field of combination product or medical device development and commercialization is desired. + Minimum of 6 years leading cross functional teams and projects. Hands on technical support and lab skills for measurement using various instruments required + Experience supporting regulated devices / combination products under Design Control (21 CFR 820), ISO13485, and ISO14791 requirements. + Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc.). + Hands on technical leadership skills with a track record of supporting on- the market products and delivering new products to market + Design for Six Sigma (DFSS) certification is desirable. + Prior experience leading & supporting projects that include managing external design, development, and manufacturing partners. + Prior technical leadership experience with creating design control/technical file deliverables and manufacturing scale-up a plus. + Proven track record of developing and gain regulatory approval of drug delivery systems a plus + Working knowledge of solid works desirable. **Key Skills and** **Competencies:** + A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971. + Extensive knowledge of engineering principles, concepts and applications. + Self-starter with strong planning and organizational skills. + An aptitude for project foresight and contingency planning. + Effective planning and organizational skills. + Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences + Strong knowledge of project management techniques, tools and metrics. + Ability to mentor technical and cross functional team members. + Strong collaboration skills with external partners. **Other Job** **Components:** **Complexity and Problem** **Solving:** + Develops and implements novel approaches and tools for data collection, management, engineering, analysis, modeling, and interpretation. + Reviews, interprets data and communicates results with Pharm Sci functions and CMC team. Planning and implementation of solutions to project problem/issues + Coordinates tech transfer with vendors. + Stays updated on related technologies/methodologies and proposes options to implement within area of expertise + Drive the evaluation of complex drug delivery systems and provide sound technical recommendations to move projects forward. + Identify, communicate and lead device design control process evolution to meet device regulations. **Internal and External** **Contacts:** + Collaborate with commercial Product teams, Quality, Mfg, Regulatory, R&D, Clinical, Legal + Work closely with Contract Lab Organizations (CLOs), Contract Manufacturing Organizations (CMOs) + Communicates activities from their functional area to project teams (pipeline, non-pipeline, and functional initiatives) and requests functional area action from the project teams to senior leaders in their functional area. + Has authority as a technical project leader to commit available resources to execute specific project tasks for project teams (pipeline, non-pipeline, and functional initiatives) upon request + May fully represent their functional area to a project teams (pipeline, non-pipeline, and functional initiatives with narrow focus) May identify topics for functional initiatives + Work closely with external design, development and manufacturing partners **Functional training for multiple laboratory technologies:** + Develops and uses basic knowledge of cross functional departments to guide junior colleagues on impact of changes and inter- dependencies. + Develops expertise in multiple laboratory technologies and leverages as functional area resource and trainer. + May have responsibility for training/mentoring of junior colleagues **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:** Lexington, MA **U.S. Base Salary Range:** $111,800.00 - $175,670.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** Lexington, 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.
    $111.8k-175.7k yearly 55d ago

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