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Sumitomo Corporation jobs - 104 jobs

  • Director, Commercial Manufacturing Validation

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Richmond, VA

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $173.2k-216.5k yearly 35d ago
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  • Medical Director, Clinical Research

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Medical Director, Clinical Development - Oncology** . The medical director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key opinion leaders. **Job Duties and Responsibilities** + Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. + Oversee project-related education of investigators, study site personnel, and study staff. + Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory meetings globally. + Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL's, and patient advocacy groups. + Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives. + Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards. + May participate in or lead clinical development contributions to due diligence or other business development activity. + As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies. + Participate in meetings and committees of parent company or other affiliates. + Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates. + Work in close collaboration with the late-stage development group. + Perform other duties as requested. **Key Core Competencies** + Ability to run a complex clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols + Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive + Able to lead through influence + Excellent communication and presentation skills are essential. + Identify the key competencies or attributes required to excel in the role. + Examples may include problem-solving, teamwork, communication, etc. + Highlight any specific qualities or traits that are important for success in the role. + These could include attention to detail, adaptability, creativity, etc. **Education and Experience** + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD required + Completion of a residency program strongly preferred + Completion of a subspecialty fellowship is desirable + Experience in blood cancers or solid tumors desirable + At least 3 years of pharmaceutical drug development experience required. The base salary range for this role is $236,100 to $295,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $236.1k-295.1k yearly 60d+ ago
  • Marketing Intern

    Perrigo Company Corporate 4.9company rating

    Charlottesville, VA job

    At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care. Description Overview Aspire for Greatness at Perrigo! Perrigo started more than 130 years ago in rural Michigan, and today it is one of the largest over the counter (OTC) self-care companies selling products globally. Our team is focused on North America and we are driven by our mission to bring quality, affordable self-care products to our consumers and retail partners. We're looking for individuals who display strong teamwork, analytical skills, and a solution-oriented mindset to join our marketing teams as we expand into new and exciting categories. Join the Aspire program to elevate your journey This summer, embrace the opportunity to learn, grow, and aspire for greatness. Perrigo provides the framework; it's up to you to write your story of achievement. At Perrigo, we're more than a step in your career; we're a bridge to your future greatness. Join Our Dynamic Marketing Teams We seek individuals with strong teamwork, analytical prowess, and a solution-oriented mindset. In the 14-week Marketing Internship, you will drive initiatives that create customer value and contribute to sales goals. Work alongside a dedicated category team on challenging projects that will enhance your technical, communication, and leadership skills outside the classroom. Scope of the Role * Lead one or more strategic projects and present final project(s) to our CSCA executive leadership team. * Dive into market research and industry data to validate trends, consumer preferences, and competitive advantages. * Spearhead new product innovations and category strategies rooted in consumer insights and sales data. * Support customer and consumer marketing, outreach, and planning. * Recommend pricing and promotional strategies that can supercharge sales and boost margins. * Collaborate cross-functionally, gaining insights into sales support, supply chain, innovation, manufacturing, finance, design, eCommerce, and consumer insights. * Set performance goals, define learning objectives, and meet project deadlines with the guidance of your supervisor and mentor. * Immerse yourself in company-sponsored training and intern events that hone your skills in marketing, sales, and personal development. * Absorb the Perrigo company culture, policies, and practices that shape every facet of our business. Experience Required * Undergraduate student majoring in Business, Marketing, or related field; junior or senior standing preferred. * Prior experience in Marketing is a plus. * Showcase excellent communication, teamwork, leadership, and problem-solving skills. * Demonstrate the ability to work independently and engage professionally with leadership at all levels. * Proficiency in Microsoft Office Suite is required. Additional Considerations * Openings in Grand Rapids, Michigan * Full-time, 40 hours per week * 14- week internship: May-Aug 2026 * Selected interns must be present for the full 14-week duration of the Summer Aspire Program. Benefits We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about Total Rewards at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo Nearest Major Market: Charlottesville Nearest Secondary Market: Virginia
    $22k-33k yearly est. 8d ago
  • Summer 2026 Internship: Bioprocess Innovation - Columbia, MD

    DSM 4.3company rating

    Columbia, MD job

    Summer 2026 Internship: Bioprocess Innovation If you're looking to grow your network and gain new skills within a global company, an internship with dsm-firmenich could be the program for you. Our summer internships provide students with opportunities to work on real business projects and gain invaluable professional experience. As an intern, you'll have exposure to many different areas of a global flavors, fragrances, and ingredients organization that works with some of the biggest brands in the world, along with opportunities to network with your peers and leadership. From engaging events to mentoring opportunities and valuable resume-building experiences, we're committed to preparing you for a fulfilling and enduring career, both at dsm-firmenich and beyond. We are currently looking for a Bioprocess Innovation Intern at our Columbia, MD office. The 2026 dsm-firmenich Summer Internship Program will run from May 26, 2026 to August 14, 2026. General Working Hours: Monday - Friday, 8:00am - 5:00pm Join our Science and Research team as an intern and gain invaluable professional experience. Enhance your skills and contribute to real projects that have visibility across the business through a summer internship. Come discover all we have to offer! Your key responsibilities * Work directly with your science mentor to advance our understanding of our microorganisms and fermentation processes. * Cultivate and then assess performance of microorganisms in experimental conditions. * Analyze and interpret your experimental results, including statistical analysis and graphical presentation. * Prepare and present your scientific findings to the project team, stakeholders and management. * Prepare and present your findings at the annual Columbia Summer Intern Poster. We bring * Build Your Future Skills: Gain hands-on experience and develop practical skills that prepare you for a successful career. * Expand Your Network: Connect with professionals and peers in a company where sustainability drives every decision and action. * Thrive in an Inclusive Culture: Join a community that values and respects every individual-regardless of background, beliefs, or identity. * Grow Through Curiosity: Work in an environment that encourages open-mindedness, learning, and collaboration to create a better future together. You Bring * Currently working on completion of a Bachelor's degree in Biology/Microbiology, Chemical/Bioprocess Engineering or related field. * Candidates must be available to work full-time beginning on May 26, 2026 - August 14, 2026. * Experience with aseptic technique and small-scale cultivations is required. * Excellent communication and interpersonal skills. * Strong organizational, problem-solving, and analytical skills with ability to synthesize and parse data. * Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. The hourly rate for this position is $23.00 - $26.00 per hour. Compensation will be dependent on factors that include location, education, training, specific skills, and years of experience. At the end of this internship, you will: * Understand how Science and Research in Columbia, MD is delivering cutting edge innovation in the fermentation of microbial lipids. * Better understand how dsm-firmenich brings the essential, desirable and sustainable to nutrition, health and beauty. * Have delivered a concrete contribution toward bringing progress to life. About dsm-firmenich: At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, belonging and equal opportunity statement: At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement: We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
    $23-26 hourly 8d ago
  • Scientist II

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Richmond, VA

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $102k-127k yearly 60d+ ago
  • Manager, R&D Applications

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Annapolis, MD

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Manager, Clinical Systems R&D IT Business Applications** who will serve as the primary liaison between R&D Clinical Operations team and IT, responsible for the delivery and support of technology solutions that align with business needs and operational demands. **_This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment_** **Job Duties and Responsibilities** + Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands + Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness + Assist in the evaluation of new technology systems and/or service providers + Oversee end-to-end management of IT projects-including planning, design, and implementation-ensuring projects are delivered on time, within scope, and with measurable business impact + Work with a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services + Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization + Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope + Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management + Manage and prioritize system enhancements and fixes in collaboration with business stakeholders + Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan + Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.) + Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes + Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction + Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion + Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas **Key Core Competencies** + Strong understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (e.g. EDC, CTMS, ETMF, Payments etc.) + 7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company + Strong understanding of building and operating a technology support function + Proficient in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment **Education and Experience** + BS/BA degree in a related discipline is required. Training or equivalent experience in IT or business management is beneficial but not required + 7+ years of experience in life sciences with a focus on IT system delivery + 5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment + Experience in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process + Excellent communication skills The base salary range for this role is $127,440 to $159,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $127.4k-159.3k yearly 60d+ ago
  • Manager, PVRM

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** (***************************************************************************************************************************************************** or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=**********&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs(s). Ability to work collaboratively with cross-functional colleagues across the SMPA organization including, but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties and Responsibilities** + Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety. + Assist in signal detection activities including data assembly, signal validation, and signal evaluation. + Perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities. + Participate and lead aggregate safety report activities including data compilation and analysis as well as writing of assigned sections (with vendor support.) + Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross-functional Safety Management Team meetings. + Represent PV Operations on cross-functional program and project teams; support PV Medical Safety activities on cross-functional program and project teams, as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician, including communication with internal and cross-functional team members, submission of data requests, and compilation of analysis and results. + Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities. + Collaborate with Clinical Development to interpret safety data from ongoing clinical trials. + Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program. + Support collaboration with external partners **Key Core Competencies** + Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, risk assessment, and safety data analysis + Proficiency with safety databases and software + Ability to evaluate and write case reports and prepare regulatory submissions + Analytical thinking and attention to detail + Communication skills for cross-functional collaboration and regulatory interactions + Project management and organizational abilities + Ability to work effectively within teams + Additionally, experience using tools such as Argus, Oracle, MedDRA, Empirica, and Excel is highly valuable for this position **Education and Experience** + Minimum of bachelor's level degree in a health care/life science related field, with Master's or other graduate degree preferred. + Minimum 3 years' experience within Pharmacovigilance and in the pharmaceutical industry. + Prior experience in oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $127.9k-159.9k yearly 60d+ ago
  • Director, Commercial Manufacturing Validation

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director, Commercial Manufacturing Validation** . This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required. **Job Duties and Responsibilities** + Accountable for contributing to validation strategies, programs, and continuous improvement initiatives. + Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and 3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities. + Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner. + Lead/support technical transfers activities from a validation and compliance perspective. + Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures. + Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs. + Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation. + Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes. + Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites. + Lead author for applicable sections in regulatory submissions. + Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products). + As needed, work as a member of SMPA's cross-functional product development teams. + Perform other duties as assigned. **Key Core Competencies** + Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations. + Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs). + Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards. + Must have strong analytical, problem solving, and statistical analysis capabilities. + Ability to work effectively in a global cross-functional team environment. + Ability to work across locations and time zones. + Strong interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner. + Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables. + Excellent written and oral communication skills. + Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. + A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. **Education and Experience** Minimum 10 - 15 years (w/o Masters) or 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma training/certification is preferred The base salary range for this role is $173,200 to $216,500. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $173.2k-216.5k yearly 35d ago
  • Trial Master File (TMF) Specialist Oncology

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $72.5k-90.6k yearly 60d+ ago
  • Director, Pricing and Contracting

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Support development of communications with Senior Executives and strategic partners to report analytical findings and key performance metrics + Develop models to set pricing strategy with the goal of supporting attainment of coverage goals and maximizing net revenue + Develop payer & provider deal models to assess the implications of deal scenarios on gross-to-net revenue and support development of business cases for review & approval by the Pricing Committee + Develop & refine gross-to-net models to support reporting and forecasting of short and long-range discount rates for Finance and the brand teams + Collaborate with the Market Access team on contract changes and amendments + Support roll-out of contracts to field staff + Review internal data/reports to ensure compliance with government pricing programs + Provide issue resolution and presentation of solutions from contract disputes + Support government price reporting and state price transparency reporting requirements **Key Core Competencies** + Experience in pharmaceutical secondary analytics and financial modeling + Understanding of Commercial and Medicare Part D pharmacy benefit designs + Understanding of gross-to-net and ROI calculations + Ability to prioritize and manage multiple tasks/assignments and meeting short deadlines + Interest in exploring and developing new approaches, processes and methodologies + Experience evaluating PBM/payer contracts to ensure they support Market Access objectives + Highly-skilled in influencing and effectively partnering with cross-functional teams + Excellent interpersonal, oral and written communication skills, project management, and confident executive presence + High level of proficiency with Microsoft Excel and PowerPoint + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Bachelor of Arts or Science in Health Sciences or related discipline; MBA preferred + Minimum 15 - 20 years (without Master's) or 10 - 15 (with Master's) of relevant experience in biotech or pharmaceutical industry + 5-7 years' experience in data analysis, financial modeling, and decision support + Preference towards previous experience with product level forecasting The base salary range for this role is $183,360 to $229,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $63k-108k yearly est. 10d ago
  • Summer 2026 Internship: Bioprocess Innovation Intern - Columbia, MD

    DSM 4.3company rating

    Columbia, MD job

    Summer 2026 Internship Program - Bioprocess Innovation Intern If you're looking to grow your network and gain new skills within a global company, an internship with dsm-firmenich could be the program for you. Our summer internships provide students with opportunities to work on real business projects and gain invaluable professional experience. As an intern, you'll have exposure to many different areas of a global flavors, fragrances, and ingredients organization that works with some of the biggest brands in the world, along with opportunities to network with your peers and leadership. From engaging events to mentoring opportunities and valuable resume-building experiences, we're committed to preparing you for a fulfilling and enduring career, both at dsm-firmenich and beyond. We are currently looking for a Bioprocess Innovation Intern at our Columbia, MD office. The 2026 dsm-firmenich Summer Internship Program will run from May 26, 2026 to August 14, 2026. Working Hours: Monday - Friday, 8:00am - 5:00pm Join our Science and Research team as an intern and gain invaluable professional experience. Enhance your skills and contribute to real projects that have visibility across the business through a summer internship. Come discover all we have to offer! Your key responsibilities * Work directly with your science mentor to advance our understanding of our microorganisms and fermentation processes. * Cultivate and then assess performance of microorganisms in experimental conditions. * Analyze and interpret your experimental results, including statistical analysis and graphical presentation. * Prepare and present your scientific findings to the project team, stakeholders and management. * Prepare and present your findings at the annual Columbia Summer Intern Poster. We bring * Build Your Future Skills: Gain hands-on experience and develop practical skills that prepare you for a successful career. * Expand Your Network: Connect with professionals and peers in a company where sustainability drives every decision and action. * Thrive in an Inclusive Culture: Join a community that values and respects every individual-regardless of background, beliefs, or identity. * Grow Through Curiosity: Work in an environment that encourages open-mindedness, learning, and collaboration to create a better future together. You Bring * Currently working on completion of a Bachelor's degree in Biology/Microbiology, Chemical/Bioprocess Engineering or related field. * Candidates must be available to work full-time beginning on May 26, 2026 - August 14, 2026. * Experience with aseptic technique and small-scale cultivations is required. * Excellent communication and interpersonal skills. * Strong organizational, problem-solving, and analytical skills with ability to synthesize and parse data. The hourly rate for this position is $23.00 - $26.00 per hour. Compensation will be dependent on factors that include location, education, training, specific skills, and years of experience. At the end of this internship, you will: * Understand how Science and Research in Columbia, MD is delivering cutting edge innovation in the fermentation of microbial lipids. * Better understand how dsm-firmenich brings the essential, desirable and sustainable to nutrition, health and beauty. * Have delivered a concrete contribution toward bringing progress to life. About dsm-firmenich: At dsm-firmenich, we don't just meet expectations - we go beyond them. Join our global team powered by science, creativity, and a shared purpose: to bring progress to life. From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere. And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future. Because real progress only happens when we go beyond, together. Inclusion, belonging and equal opportunity statement: At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong. We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve. We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you. And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work. Agency statement: We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role.
    $23-26 hourly 8d ago
  • Scientist II

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $102k-127k yearly 60d+ ago
  • Associate Director, Marketing Analytics - OAB

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Richmond, VA

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** The **Associate Director, Marketing Analytics - OAB** position will lead business insights for the commercial organization as it relates to the Overactive Bladder therapeutic area. This role will be required to operate with diverse data sources, vendors, stakeholders, in a rapidly changing business environment. This position will report to the **Director, Commercial Analytics - OAB** and will be an integral part of the Commercial Analytics team. This position will partner with marketing, finance, and market access leadership, along with other Commercial Analytics leaders to deliver accurate, timely, and reliable insights to stakeholders across the commercial organization. **Job Duties and Responsibilities** + Perform a critical role in enhancing marketing offerings by developing integrated insights from data/information to shape commercial strategy and decisions. + Partnering with key stakeholders, create and execute annual market research and analytics plans that align to brand strategy and performance measurement needs. + Conduct advanced analytics for brand teams to inform brand planning, promotional resource allocation, and marketing strategies, including patient journey creation and ROI analysis. + As part of the Gemtesa brand planning process, support the development brand-specific situational analysis, participate in tactical planning, and partner with sales and marketing to create meaningful KPIs. + Closely involved with financial planning process, providing key insights and assumptions for annual and long-range plan forecasting in partnership with brand leadership. + Develop compelling and actionable insights presentations for key stakeholders, including brand leadership, cross-functional partners, and senior management while adapting communication style based on audience. + Lead the development of deep dive analytical suite assimilating insights from multiple sources, both internal and external, to help provide a thorough understanding of brand performance. + Develop strategic partnership as the point of contact for Gemtesa brand team. + Develop and prioritize key business questions with the cross-functional support of medical, clinical, brand teams, and other partners in the organization. + Manage development anddelivery of strategic KPIs and supporting metrics for the monthly and quarterly business reviews. + Direct analytic ad hoc project requests related to the Gemtesa brand team. **Key Core Competencies** + Strategic thinker: can see big picture opportunities and translate into actionable plans. + Excellent written and oral communications skills including executive presence in formal stakeholder presentations. + Strong knowledge and experience with pharmaceutical data sources (i.e., IQVIA, SHA, MMIT/DRG formulary / market access data). + Strong knowledge and experience with patient and HCP market research and translating insights from research into actionable recommendations. + Strong understanding of omnichannel data and media promotion measurement (e.g. Crossix, Media Agencies, etc). + Proven success in developing analyses with Business Intelligence tools and methods (e.g., Tableau, Qlikview, SQL). + Excellent team player and collaborative skills. + Strong demonstrated project management skills and managing external vendors/ deliverables within tight timelines. + Strategic partner to multiple cross-functional stakeholders. + Ability to understand the commercial environment and business needs and translate to workable solutions. + Highly motivated change agent that can push against the status quo and seed new ideas, new ways of thinking, and new ways of working. **Education and Experience** + Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry. + Previous marketing, marketing science, or omnichannel experience preferred. + Previous commercial/ brand analytics experience (with Statistical Packages) preferred (e.g., SAS, R, SPSS, etc). + Patient/consumer and HCP insights and strategy experience. The base salary range for this role is $150,640 to $188,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $150.6k-188.3k yearly 60d+ ago
  • Senior Manager, Business Systems

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Position Summary** The Senior Manager **(Source-to-Applications)** will lead the solution, design, and delivery of the company's **Source-to-Pay (S2P)** technology ecosystem, encompassing **Coupa, SAP as ERP, and related integration layers** . This role is responsible for ensuring seamless process alignment between **Procurement, Finance, and Supply Chain** , optimizing technology investments, and enabling digital transformation through automation and data-driven insights. The ideal candidate combines **deep functional knowledge of procurement and finance processes** with strong technical acumen in **Coupa, SAP, integrations, and governance** . **Key Responsibilities** **Leadership** · Serve as the IT solution lead for Coupa, SAP MM/FI, and other related procurement and finance systems. · Partner with Procurement, Finance, and IT leadership to drive process optimization, compliance, and cost efficiency. · Champion best practices for digital sourcing, procurement analytics, supplier collaboration, and contract management. **Application & Integration Management** · Responsible for system configuration, enhancements and support for **Coupa modules** (Procure-to-Pay, Sourcing, Contract Lifecycle Management, Supplier Management, Invoicing). · Manage integrations between Coupa, **SAP ERP** , **Workday** , **banking** , and **3rd-party applications** using middleware. · Lead upgrades, testing, and change control processes across Coupa and SAP landscapes. **Operational Excellence** · Ensure compliance with internal controls, audit, and regulatory requirements (SOX, GDPR, etc.). · Drive data quality and master data governance across supplier, contract, and spend domains. · Manage MSP and vendor resources ensuring SLA adherence and value realization. **Team & Stakeholder Leadership** · Lead developers, and functional consultants for projects and support. · Act as a **trusted advisor** to Procurement and Finance leaders for digital transformation opportunities. · Collaborate with IT peers across ERP, HR, and analytics functions to deliver integrated enterprise solutions. **Qualifications** **Education:** Bachelor's degree in Information Systems, Finance, or Business Management (Master's preferred). **Experience:** · 10+ years of experience in enterprise applications or IT solution delivery. · 7+ years leading Source-to-Pay or Procure-to-Pay systems (preferably Coupa and SAP). · Proven experience managing large-scale ERP and SaaS integrations. · Strong understanding of end-to-end procurement, sourcing, invoicing, and payments processes. · Demonstrated success in project governance, vendor management, and stakeholder engagement. **Skills & Competencies:** · Expert in **Coupa functional configuration** and **SAP integration** (especially MM, FI, and AP modules). · Capable of translating complex business needs into scalable technical solutions. · Proficient with middleware SAP CPI and API-based integrations. · Knowledge of **workflow automation** , **RPA** , and **data visualization tools** (Power BI, Tableau) a plus. · Strong leadership, communication, and change management skills. **Preferred Certifications** - Coupa Certified Professional. - SAP certification (MM, FI/CO, or Integration). The base salary range for this role is $145,280 to $181,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $145.3k-181.6k yearly 24d ago
  • Scientist II

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Charleston, WV

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $102k-127k yearly 60d+ ago
  • Associate Medical Director, Clinical Research

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Washington, DC

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Associate** **Medical Director, Clinical Development - Oncology** . The associate medical director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key opinion leaders. **Job Duties and Responsibilities** + Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. + Oversee project-related education of investigators, study site personnel, and study staff. + Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory meetings globally. + Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL's, and patient advocacy groups. + Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives. + Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards. + May participate in or lead clinical development contributions to due diligence or other business development activity. + As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies. + Participate in meetings and committees of parent company or other affiliates. + Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates. + Work in close collaboration with the late-stage development group. + Perform other duties as requested. **Key Core Competencies** + Ability to run a complex clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols + Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive + Able to lead through influence + Excellent communication and presentation skills are essential. + Identify the key competencies or attributes required to excel in the role. + Examples may include problem-solving, teamwork, communication, etc. + Highlight any specific qualities or traits that are important for success in the role. + These could include attention to detail, adaptability, creativity, etc. **Education and Experience** + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD + Completion of a residency program strongly preferred + Completion of a subspecialty fellowship is desirable + Experience in blood cancers or solid tumors desirable + 0 to 5 years of pharmaceutical drug development experience required. The base salary range for this role is $187,900 to $234,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $187.9k-234.9k yearly 60d+ ago
  • Trial Master File (TMF) Specialist Oncology

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Annapolis, MD

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $72.5k-90.6k yearly 60d+ ago
  • Director, Pricing and Contracting

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Annapolis, MD

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Duties and Responsibilities** + Support development of communications with Senior Executives and strategic partners to report analytical findings and key performance metrics + Develop models to set pricing strategy with the goal of supporting attainment of coverage goals and maximizing net revenue + Develop payer & provider deal models to assess the implications of deal scenarios on gross-to-net revenue and support development of business cases for review & approval by the Pricing Committee + Develop & refine gross-to-net models to support reporting and forecasting of short and long-range discount rates for Finance and the brand teams + Collaborate with the Market Access team on contract changes and amendments + Support roll-out of contracts to field staff + Review internal data/reports to ensure compliance with government pricing programs + Provide issue resolution and presentation of solutions from contract disputes + Support government price reporting and state price transparency reporting requirements **Key Core Competencies** + Experience in pharmaceutical secondary analytics and financial modeling + Understanding of Commercial and Medicare Part D pharmacy benefit designs + Understanding of gross-to-net and ROI calculations + Ability to prioritize and manage multiple tasks/assignments and meeting short deadlines + Interest in exploring and developing new approaches, processes and methodologies + Experience evaluating PBM/payer contracts to ensure they support Market Access objectives + Highly-skilled in influencing and effectively partnering with cross-functional teams + Excellent interpersonal, oral and written communication skills, project management, and confident executive presence + High level of proficiency with Microsoft Excel and PowerPoint + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Bachelor of Arts or Science in Health Sciences or related discipline; MBA preferred + Minimum 15 - 20 years (without Master's) or 10 - 15 (with Master's) of relevant experience in biotech or pharmaceutical industry + 5-7 years' experience in data analysis, financial modeling, and decision support + Preference towards previous experience with product level forecasting The base salary range for this role is $183,360 to $229,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $63k-109k yearly est. 10d ago
  • Associate Director, Marketing Analytics - OAB

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Annapolis, MD

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** The **Associate Director, Marketing Analytics - OAB** position will lead business insights for the commercial organization as it relates to the Overactive Bladder therapeutic area. This role will be required to operate with diverse data sources, vendors, stakeholders, in a rapidly changing business environment. This position will report to the **Director, Commercial Analytics - OAB** and will be an integral part of the Commercial Analytics team. This position will partner with marketing, finance, and market access leadership, along with other Commercial Analytics leaders to deliver accurate, timely, and reliable insights to stakeholders across the commercial organization. **Job Duties and Responsibilities** + Perform a critical role in enhancing marketing offerings by developing integrated insights from data/information to shape commercial strategy and decisions. + Partnering with key stakeholders, create and execute annual market research and analytics plans that align to brand strategy and performance measurement needs. + Conduct advanced analytics for brand teams to inform brand planning, promotional resource allocation, and marketing strategies, including patient journey creation and ROI analysis. + As part of the Gemtesa brand planning process, support the development brand-specific situational analysis, participate in tactical planning, and partner with sales and marketing to create meaningful KPIs. + Closely involved with financial planning process, providing key insights and assumptions for annual and long-range plan forecasting in partnership with brand leadership. + Develop compelling and actionable insights presentations for key stakeholders, including brand leadership, cross-functional partners, and senior management while adapting communication style based on audience. + Lead the development of deep dive analytical suite assimilating insights from multiple sources, both internal and external, to help provide a thorough understanding of brand performance. + Develop strategic partnership as the point of contact for Gemtesa brand team. + Develop and prioritize key business questions with the cross-functional support of medical, clinical, brand teams, and other partners in the organization. + Manage development anddelivery of strategic KPIs and supporting metrics for the monthly and quarterly business reviews. + Direct analytic ad hoc project requests related to the Gemtesa brand team. **Key Core Competencies** + Strategic thinker: can see big picture opportunities and translate into actionable plans. + Excellent written and oral communications skills including executive presence in formal stakeholder presentations. + Strong knowledge and experience with pharmaceutical data sources (i.e., IQVIA, SHA, MMIT/DRG formulary / market access data). + Strong knowledge and experience with patient and HCP market research and translating insights from research into actionable recommendations. + Strong understanding of omnichannel data and media promotion measurement (e.g. Crossix, Media Agencies, etc). + Proven success in developing analyses with Business Intelligence tools and methods (e.g., Tableau, Qlikview, SQL). + Excellent team player and collaborative skills. + Strong demonstrated project management skills and managing external vendors/ deliverables within tight timelines. + Strategic partner to multiple cross-functional stakeholders. + Ability to understand the commercial environment and business needs and translate to workable solutions. + Highly motivated change agent that can push against the status quo and seed new ideas, new ways of thinking, and new ways of working. **Education and Experience** + Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry. + Previous marketing, marketing science, or omnichannel experience preferred. + Previous commercial/ brand analytics experience (with Statistical Packages) preferred (e.g., SAS, R, SPSS, etc). + Patient/consumer and HCP insights and strategy experience. The base salary range for this role is $150,640 to $188,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $150.6k-188.3k yearly 60d+ ago
  • Scientist II

    Sumitomo Pharma 4.6company rating

    Sumitomo Pharma job in Annapolis, MD

    Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Scientist II. This position will be part of the Translational Research and Medicine-Oncology team, with a primary focus on advancing translational research to support oncology programs in clinical trial stages. This individual will be responsible for designing, oversighting, and interpretating translational studies to understand mechanism of action, resistance pathways, and potential new indications. The candidate may also be involved in biomarker analysis to support these translational objectives. **Job Duties and Responsibilities** + Develop hypotheses by integrating insights from scientific literature, preclinical and clinical data + Design experiments to support identification of mechanism of action, resistance mechanisms, and potential indications + Manage translational research and biomarker studies conducted with CROs and academic investigators to ensure high-quality, timely delivery of data + Maintain organized, detailed logs of studies and data to ensure accuracy, reproducibility, and compliance with regulatory standards + Present data and insights in internal meetings and cross-functional program team discussions **Key Core Competencies** + Scientific curiosity with ability to generate and test hypotheses that inform drug development + Excellent problem-solving and critical-thinking skills to interpret complex data + Strong organizational skills and attention to detail in managing studies, data, and documentation + Strong project management and vendor oversight skills + Adaptability and resilience in a fast-paced, evolving research environment **Education and Experience** + PhD degree in a related field of science (Biology, Biochemistry, Molecular & Cellular biology, Cancer Biology, Immunology) + 1-3 years of postdoctoral or industry research experience + Familiarity with oncology research preferred + Experience with common biomarker platforms (e.g. NGS, flow cytometry, IHC) preferred The base salary range for this role is $102,000 to $127,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. 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. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** 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; 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. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
    $102k-127k yearly 60d+ ago

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Sumitomo Corporation may also be known as or be related to SUMITOMO CORP, Sumitomo and Sumitomo Corporation.