Sumitomo Corporation jobs in Sacramento, CA - 23 jobs

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. We are currently seeking a dynamic individual who will serve as administrative support to the Legal Department, responsible for performing legal administration activities, supporting process improvements, and identifying operational efficiency opportunities across the legal function. This role is essential in ensuring the department operates with optimal effectiveness, aligning with the broader goals of the organization. **Job Duties and Responsibilities** _Process Improvement & Operational Efficiency_ + Identify, design, and implement scalable legal processes and workflows to improve efficiency and reduce risk. + Support all aspects of setting up and maintaining purchase orders. + Support work orders and invoicing under intercompany and external vendor agreements. + Obtain and submit accruals from external vendors in compliance with applicable laws. + Support Chief Legal Officer's direct reports with meeting scheduling and expense reports. + Review and distribute mail in compliance with company data retention schedule. + Manage Legal Teams channel and filing site in compliance with company data retention schedule, and to ensure consistent organizational structure and efficient access to information. _Project & Vendor Management_ + Support legal department projects and initiatives (e.g., system/process implementations, restructuring activities), including timelines, deliverables, and stakeholder communications. + Retrieve contracts from and uploading contracts to ECMS (CLM). + Oversee relationships with external counsel and legal vendors, including ensuring engagement letters are in place and on file, and POs in place. + Monitor legal spend and support budgeting, forecasting, and cost-saving initiatives. _Compliance & Governance_ + Support corporate governance activities, including board documentation, policy development, regulatory filings, and entity restructuring. + Ensure legal operations align with pharmaceutical compliance standards and industry regulations. _Team Collaboration & Communication_ + Act as a liaison between legal and other departments to ensure seamless legal service delivery. + Support preparation of PowerPoint presentations. **Key Competencies** + Experience supporting legal teams in a regulated industry. + Ability to manage multiple priorities in a fast-paced environment. + Strategic thinker with a continuous improvement mindset. + Comfortable working with senior leadership and cross-functional teams. **Education and Experience** + Bachelor's degree required; paralegal certification preferred. + 3-5 years of experience in legal administration with some operational experience + Demonstrated experience in process improvement, project management, and cross-functional collaboration. + Proficiency in legal tech platforms (e.g., CLM (ECMS/iCertis), e-billing, Oracle, SAP, Workday, PowerPoint, Word, Excel) preferred. + Excellent organizational, analytical, and communication skills. The base salary range for this role is $62,600 to $78,200. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, overtime, 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 up to 120 hours of vacation per year, 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 and access to our service recognition program. 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_

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. We are seeking a highly skilled and collaborative **Senior Manager, Web Development** to lead the design, development, and support of our company's external web properties. This includes websites supporting Marketing, Corporate Communications, and Medical Affairs. The ideal candidate combines front-end development expertise with excellent communication and leadership skills to translate business needs into elegant, secure, and scalable web solutions. **Key Responsibilities** + Lead the Web Services team in building and maintaining public-facing websites on the AWS platform using Vue.js and Nuxt frameworks. + Partner with business stakeholders across Marketing, Corporate Communications, and Medical Affairs to gather requirements, propose solutions, and ensure align with corporate branding and compliance standards. + Oversee the full web development lifecycle - architecture, development, testing, deployment, and ongoing optimization. + Manage vendor and agency relationships for specialized design, content, and quality assurance. + Ensure web solutions adhere to industry best practices for security, accessibility (WCAG), SEO, and performance. + Champion agile delivery practices and modern CI/CD pipelines to ensure quality and efficiency. + Mentor front-end developers and establish coding standards and development best practices. + Stay current with emerging web technologies, frameworks, and regulatory guidance relevant to pharmaceutical digital content **Required Qualifications** + Bachelor's degree in Computer Science, Information Technology, or a related field (or equivalent experience). + 8+ years of experience in front-end web development, including Vue.js, Nuxt, Node.js, JavaScript, HTML5, CSS3, Tailwind CSS, GitHub, ColdFusion, MySQL. + 3+ years in technical leadership or management role overseeing web development projects and managing development teams. + Hands-on experience deploying and managing web applications on AWS (e.g., CloudFront, S3, Lambda, API Gateway). + Experience integrating web platforms with analytics tools (Google Analytics, Google Tag Manager, Google Search Console) and tag management systems. + Strong understanding of responsive design, accessibility standards, and SEO principles. + Proven ability to coordinate various timelines, cross-functional teams, and external resources to meet deadlines. + Excellent communication and collaboration skills, with the ability to translate technical concepts for non-technical stakeholders. + Proven track record managing multiple projects and priorities simultaneously in a fast-paced environment. + Exceptional attention to detail and a commitment to delivering high-quality, error-free solutions. + Experience within the pharmaceutical, biotech, or healthcare industries. + Familiarity with digital content approval workflows (e.g. Veeva PromoMats or equivalent). The base salary range for this role is $140,900 to $176,100. 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_

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_

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 leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced in Oncology. In addition, the candidate must have recent Oncology NDA submission experience and submissions worldwide including HTA submissions. The individual will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international submissions. In addition, the candidate must be experience with supporting all aspects of global commercial product. The role will hold accountability for regulatory submissions, applicable communications, and compliance across the company's new and established programs. This position reports to the Chief Medical Officer. **Job Duties and Responsibilities** + Strategic thought partner including with but not limited to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the advertising and promotion of prescription drugs + Guide and/or lead regulatory agency interactions, including communications and meetings + Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion in accordance with business goals and objectives, regulations, guidelines, and company policy. + Manage and/or support the development and implementation of policies, procedures and tools related to advertising, promotion, and labeling + Manage compliance and risks related to R&D activities, especially activities of regulatory affairs, (e.g., SOPs) + Set clear standards and expectations for the accurate and timely reporting of status of all regulatory affairs activities; provide relevant input to Leadership + Oversee the regulatory activities at CROs, providing document review in order to ensure the quality and scientific integrity of documents submitted to regulatory authorities + In collaboration with Commercial, Medical and Legal colleagues, conduct a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims and assess consistency of proposed claims with FDA-approved labeling + Provide regulatory leadership to the respective cross-functional teams charged with advertising and promotion review to ensure compliance of promotional materials including, but not limited to, Physician and Patient Sales, Marketing and Educational Materials, Training Materials, Slide Presentations and press releases and external communications in compliance with FDA regulations and Company policies + Serve as the regulatory member of the scientific Medical Review Committee (sMRC) to ensure regulatory compliance for medical based communications, congresses, and ad boards. + Serve as primary contact leading and facilitating communications with the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products, including pre-clearance of launch materials. + Direct and ensure the timely submission of all applicable approved promotional materials to the FDA on Form 2253s + Ensure compliance of labeling, promotional and educational materials with governing Health Authorities. + Managing responsibilities for direct reports within the commercial regulatory team for both product promotional review and product promotion submissions to FDA for both women's health and prostate cancer + Recruits, develops, manages and mentors regulatory professionals and drives a culture of excellence and motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals + Provide leadership and direction to clinical regulatory. Provide coaching and development and drive a culture of excellence that motivates employees to perform at their highest ability. Rewards and recognizes employees and teams who take initiative beyond expectations to advance business goals. **Key Core Competencies** + Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively + Exercise good judgment and make decision that is appropriate for the organization + Results-driven, take initiative and ownership to accomplish work + Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment + Strive for continuous improvement and embrace innovative ideas in daily work + Demonstrate coaching skill to inspire, develop, and motivate team + Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables. + High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture **Education and Experience** + Advanced degree in a relevant scientific discipline required. + Doctoral degree (MD, PharmD, or PhD) preferred + 15 years of biopharmaceutical experience, which include at least 10 years of direct experience in Regulatory Affairs in Oncology + Demonstrated experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA Experience in Oncology required + Demonstrated leadership skill leading a functional team + Comprehensive knowledge and interpretive understanding of global regulations and guidelines (nonclinical, clinical, labeling, promotional) + Strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (eg, changing regulatory environment, new competition, shifting market environment) along with the ability to balance short-term needs with long-term vision. The base salary range for this role is $280,560 to $350,700. 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_

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 Senior Medical Director, Clinical Research (Ophthalmology) to join our R&D Organization. This individual will contribute to the design and execution of clinical development plan(s) for assigned asset(s) and serve as the Clinical Research Lead for stem cell program within the Ophthalmology therapeutic area. **Job Duties and Responsibilities** + Responsible for and lead all activities related to clinical study design from clinical study concept to clinical study protocol for both early- and late-stage programs + Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions + Leads and drives strategy for clinical studies for assigned asset(s) within the Ophthalmology therapeutic area + Provides oversight of clinical trial conduct, interacting with CROs, medical monitors, and vendors as required, and working with the safety group to ensure adequacy of safety monitoring and reporting + Provide clinical input for and participate in study set up and design including data collection tools, data analysis, eCRF design, edit checks, vendor database design plans, etc. + Study-level, site-level and subject-level data review and interpretation, including documentation and summarization of findings + Serve as the internal medical monitoring for clinical trials + Review and provide input for the design of the statistical analysis plans, TLFs, and the clinical data output + Contributes to interpretation of clinical trial results and the writing of clinical study reports + Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in compliance with appropriate scientific/regulatory/medical standards + Contributes to developing clinical components of BLA/NDAs, sNDAs, MAAs and other regulatory filing documents + Contributes to company responses to health authorities and ethics committees for ongoing clinical programs to ensure timely registration and initiation of trials globally + Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings, and national and international scientific meetings + Serve as the subject matter expert for ophthalmology, representing Clinical Research to both internal and external customers + 20% domestic and international travel **Key Core Competencies** + Knowledge and understanding of FDA, GCP, and ICH regulations and guidance + Thorough and up-to-date knowledge of therapeutic area including trends, advances, understanding of currently available therapies and competitive clinical landscape + Experience in conducting global clinical trials in both early- and late-stage clinical development, especially protocol development and trial initiation + Experience in regulatory submissions in US; preferred experience in Europe and Japan + Demonstrated ability to set clear priorities, lead, influence and build consensus in a multi-disciplined team environment + Strong team leadership skills and ability to motivate large multi-functional teams + Ability to effectively synthesize, interpret and present scientific information to both internal stakeholders and external medical community + High degree of organizational awareness, ability to connect the dots to understand all the interdependencies and big picture + Excellent interpersonal and communication skills with the ability to balance multiple tasks and work within a multi-disciplinary team **Education and Experience** + MD (or international equivalent) + Board certified or board eligible in ophthalmology + Fellowship training in vitreoretinal surgery (preferred) or retina + A minimum of 5 years' experience in the pharmaceutical industry, with experience as Clinical Research Lead in Ophthalmology therapeutic area + Experience in regenerative cell medicine or gene therapy preferred + Prior experience working with Japan organizations is preferred The base salary range for this role is $284,320 to $355,400. 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_

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 Business Applications team is part of IT and is responsible for supporting, developing, managing and enhancing the capability of enterprise applications which make up the platform that delivers SMPA's business processes. The Manager, Enterprise Apps, Workday Architect is responsible for partnering with HR to architect the company's HR applications including Workday and other integrated HR platforms (e.g., benefits, time tracking, learning, and recruiting, payroll systems). This role serves as the primary liaison between IT, HRIS, and HR stakeholders, ensuring that HR applications align with enterprise architecture standards, IT compliance requirements, and business goals. The ideal candidate has hands-on Workday experience, a strong understanding of HR processes, and proven success in leading system enhancements, integrations, and IT data governance initiatives. **Key Responsibilities** Systems Management & Architecture + Serve as the technicallead for **Workday** and other HR-related applications. + Design andmaintainthe **HR systems architecture** , ensuring alignment with enterprise IT standards and data governance policies. + Oversee Workday configuration, testing, and deployment across modules (HCM, Absence, Compensation, Talent, Recruiting, Learning, and others). + Manage integrations between Workday and downstream systems such as SAP, Payroll, Finance, and Identity Management platforms. + Ensure stability, scalability, and continuous improvement of HR systems through proactive monitoring and optimization. + Design,monitor, and troubleshoot integrations between Workday and external systems (e.g., ERP, Finance, Payroll providers, Identity Management). Stakeholder Engagement + Partner with HR, IT, and Finance stakeholders to deliver high-impact HR technology solutions. + **Primary liaison** for WorkdayTechnicalsupport, helpdesk, and enhancement requests. + Provide functional guidance and mentorship to HRIS analysts or other team members. Data, Reporting & Compliance + Managedata governance, ensuring accuracy, consistency, and compliance with data privacy and audit requirements. + Develop andmaintainreports, dashboards, and analytics to support business decisions. + Support internal and external audits by ensuring proper system controls and documentation. **Education & Experience:** + Bachelor's degree in information systems, Computer Science, Human Resources, or Business Management (Master'sdegree preferred). + 7+ years of hands-on Workday and HR Applications IT experience + Strong understanding of HR business processes (Core HR, Recruiting, Performance, Learning, Compensation, and Payroll). + Proven success in project management, system upgrades, and cross-functional collaboration. + Experience integrating Workday with ERP (SAP), payroll, and identity management systems. + Workday Pro Certification(s) in one or more modules (HCM, Compensation, Reporting, Integrations) is preferred. + Experience with Workday Extend is desired. + Proficient in Workday Studio, EIB, and Report Writer. + Strong analytical and troubleshooting skills. + Deep understanding of security roles, data governance, and SOX/ GDPR compliance. + Strong problem-solving, documentation, and communication skills. The base salary range for this role is $110,452 to $138,065. 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_

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_

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_

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_

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_

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 Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority (HA) information requests. In addition, this position may represent GRA in project related meetings, develop regulatory strategy and provide regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring. **Job Duties and Responsibilities** + As a Regional Regulatory Lead, manage regional (United States, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT) + As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs + Supports and/or leads documentation of regulatory authority interactions including decisions and outcomes + Leads and coordinates project team members in developing strategy for applicable documents/ activities. + Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level + Provide updates to the Global Regulatory Team, project teams, and governance boards as needed + Maintains professional working relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Advises team members of potential regulatory issues and provides possible solutions and mitigation strategy + Ensures the quality and content of all submissions to Health Authorities + Contributes to regional health authority meetings, and briefing book documentation to Health Authorities + Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed. **Key Core Competencies** + Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required + Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values + Ability to work in a diverse environment + Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization + Demonstrated ability to facilitate appropriate team decisions + Sense of urgency and perseverance to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed + Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution + Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to make complex decisions and willingness to defend difficult positions. + Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in a related field required, preferably in a scientific discipline. + At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience preferred + Experience contributing to electronic regulatory submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials The base salary range for this role is $156,000 to $195,000 . 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_

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_

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 **Sales Account Manager, Oncology.** In this field-based role, the Prostate Cancer Sales Specialist will focus on achieving sales goals in their assigned geographic territory. This role serves the Greater Charlotte area and the successful candidate must live within territory. This individual will have a proven record of success in urology and/or medical oncology and will be highly collaborative, tactical, energetic and thrive in a nimble, start-up organization. The Prostate Cancer Sales Specialist will demonstrate a sense of urgency to prepare and successfully execute a new product launch plan for their assigned geography. The Prostate Cancer Sales Specialist will drive results through the sales team that is consistent with the company's goals, mission, and values. **Job Duties and Responsibilities** + Ensures a successful outcome of product launch plans and achievement of territory sales objectives through execution of Brand Plan of Action strategies and tactics. + Maintains excellent working relationships with all customer key stakeholders including medical oncology, urology providers, radiation oncologists, medical groups, patient advocacy groups, and all support staff for prostate cancer treatment. + Becomes an expert in product information and effectively verbalizes clinically relevant and approved messaging to all stakeholders. + Drives product demand through clinically meaningful and interactive dialogue with HCPs, a thorough understanding of the prostate cancer patient journey, product knowledge and expertise, and use of all approved educational resources. + Creates and implements an effective territory business plan to guide strategy, tactics and track progress. + Monitors and assesses competitive sales activity in the market. Shares information and makes recommendations to leadership. + Partners with Regional Sales Directors, Marketing, Training and Development, Commercial Operations, Market Access team and other internal stakeholders to effectively execute the launch plan. + Acts in compliance with SMPA commercial compliance policy, all applicable federal and state laws and guidance relating to product promotion and information dissemination including, but not limited to, the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration's implementing regulations, the Federal Anti-Kickback Statute, the False Claims Act, PhRMA, Corporate Code of Business Conduct and the Office of the Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers. + The specialty representative role will require territory coverage of a potentially large geographic area, which may include occasional overnight travel. **Key Core Competencies** + Has a proven, consistent track record of exceeding sales goals in assigned geography. + Proven to be successful in all respects of selling, i.e. technical knowledge, sales techniques, interpreting/analyzing data, and has an in-depth understanding of the medical oncology and/or urology space. + Understands, analyzes and effectively presents scientific/technical details and marketing materials. + Proficiency in virtual/remote customer access and interactions. + Demonstrated proficiency in leveraging technology platforms and business hardware/software. + Experience with total office calls, including ability to confidently and compliantly discuss various practice business drivers such as GPO contracts, IDN influence, reimbursement and copay implications. + Knowledge and understanding of payer mix, reimbursement environment, and distribution influence in assigned territory. **Education and Experience** + Candidates will possess a BA or BS degree, preferably in life sciences or business administration. + 7+ years of validated commercial experience in the pharmaceutical, diagnostic or healthcare industry, preferably in specialty pharmaceuticals. + Current or very recent experience in Urology, Oncology, or Men's Health. + Recent oncology and/or urology promotion and/or product launch experience preferred. + Working in a start-up company and/or division, reflecting an entrepreneurial culture preferred. + Account Management, Market Access, or Advocacy experience desirable + Experience in Account Based Settings (Academic Hospital and IDN's) **TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT** + Successful candidates must live within territory; greater Charlotte area. + A valid license and satisfactory Motor Vehicle Report (MVR) is required + Approximately 25-30% travel is required; overnight travel is required as needed + Regularly required to operate standard office equipment + Ability to work on a computer for extended periods of time + Regularly required to sit for long periods of time, and occasionally stand and walk + Regularly required to use hands to operate computer and other office equipment + Close vision required for computer usage + Occasionally required to stoop, kneel, climb and lift up to 20 pounds The base salary range for this role is $150,400 to $188,000. 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_

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 **Senior Manager, Information Record Governance** **.** This position is responsible for the end-to-end management of the organization's data loss prevention (DLP) program, e-discovery processes, litigation hold administration, and records retention policies. This role ensures the protection, preservation, and defensible management of electronic information in compliance with legal, regulatory, and business requirements. **Job Duties and Responsibilities** **Data Loss Prevention (DLP)** + Develop, implement, and maintain DLP policies and controls to safeguard sensitive information from unauthorized access, misuse, or leakage + Monitor network, endpoints, and cloud environments for potential data breaches and respond to DLP alerts. + Collaborate with IT and Legal teams to configure, test, and optimize DLP solutions. + Conduct risk assessments and vulnerability analyses related to data protection. + Provide training and awareness programs for employees on DLP best practices. **E-Discovery** + Manage the identification, preservation, collection, and processing of electronically stored information (ESI) for legal and regulatory matters + Coordinate with Legal, Compliance, and IT teams to execute discovery plans and ensure defensibility of collected data. + Operate and maintain e-discovery platforms and tools; apply search terms, filters, and deduplication techniques. + Prepare documentation and reports for legal teams and regulators. **Litigation Holds** + Administer litigation hold processes, including issuing, tracking, and releasing holds in collaboration with Legal and Compliance + Notify affected employees and ensure acknowledgment of holds; monitor compliance with preservation requirements. + Maintain accurate records of active and released holds; periodically review holds for relevance and necessity. + Support legal teams in responding to discovery requests and audits. **Records Retention** + Develop and enforce records retention schedules and policies in accordance with regulatory and business requirements + Oversee the secure storage, retrieval, and disposal of records, both physical and electronic. + Suspend routine deletion procedures when litigation, investigation, or regulatory events require preservation. + Conduct periodic audits to ensure compliance with retention and disposal policies. **Key Core Competencies** + Attention to detail and commitment to compliance. + Ability to manage multiple priorities and deadlines. + Collaborative approach with Legal, IT, and Compliance teams. + Problem-solving and incident response skills. + Ability to educate and influence at all levels of the organization. **Qualifications** + Bachelor's degree in Information Systems, Computer Science, Legal Studies, or related field. + Relevant certifications (e.g., CEDS, CISSP, CISM) preferred. + 6+ year experience partnering with Legal or Compliance teams to ensure adherence to regulatory requirements and organizational policies and 3+ years of experience in DLP, e-discovery, records management, or information governance. + Proficiency with DLP and e-discovery tools (e.g., Microsoft DLP, Symantec, Relativity, Nuix). + Excellent analytical, organizational, and communication skills. + Strong understanding of data protection regulations (e.g., GDPR, HIPAA, CCPA) and legal hold protocols. The base salary range for this role is $152,200 to $190,200. 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_

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** Lead IT compliance and governance programs in a regulated pharmaceutical environment. Ensure adherence to global regulations (GxP, FDA, EMA), manage IT risk, and oversee Business Continuity and Disaster Recovery. Partner with QA, Regulatory, and IT teams to maintain secure, compliant, audit-ready systems. **Job Duties and Responsibilities** + **Regulatory Compliance & GxP Oversight** + Ensure IT systems supporting GxP processes comply with FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations. + Maintain IT compliance documentation including validation protocols, SOPs, and audit trails. + Oversee periodic IT compliance assessments and manage remediation plans. + **Governance & Risk Management** + Develop and maintain IT governance frameworks aligned with pharmaceutical industry standards and corporate policies. + Conduct IT risk assessments for systems supporting clinical, manufacturing, and commercial operations. + Implement risk mitigation strategies and maintain risk registers. + **Business Continuity & Disaster Recovery (BC/DR)** + Own and manage the enterprise BC/DR program for IT systems. + Develop, maintain, and test disaster recovery plans to ensure resilience and rapid recovery of critical systems. + Coordinate with business units to align continuity strategies with operational priorities. + Ensure compliance with regulatory expectations for BC/DR in pharmaceutical environments. + **Audit & Inspection Readiness** + Serve as the primary IT contact for internal audits, regulatory inspections, and third-party assessments. + Ensure timely resolution of audit findings and continuous improvement of compliance posture. + **Policy & Standards Development** + Establish IT policies and standards for data integrity, cybersecurity, system lifecycle management, and BC/DR. + Ensure consistent application of governance principles across GxP and non-GxP systems. + **Training & Awareness** + Develop and deliver IT compliance and BC/DR training programs for system owners and end-users. + Promote a culture of compliance and resilience across IT and business teams. + **Cross-Functional Collaboration** + Partner with Quality, Regulatory, Clinical, and Manufacturing teams to ensure IT solutions meet compliance and continuity requirements. + Provide guidance on regulatory impacts for new technologies and digital initiatives. **Qualifications** + **Education:** Bachelor's degree in Information Technology, Computer Science, or related field; advanced degree preferred. + **Experience:** + 8+ years in IT compliance, governance, or risk management within a pharmaceutical or life sciences environment. + Strong knowledge of GxP, FDA 21 CFR Part 11, EU Annex 11, and global regulatory frameworks. + Proven experience managing audits, inspections, and BC/DR programs in a regulated industry. **Key Core Competencies** + Deep understanding of IT systems validation, data integrity principles, cybersecurity controls, and BC/DR best practices. + Excellent communication and stakeholder management skills. + Ability to influence and lead cross-functional teams **Preferred Certifications:** + CISA, CRISC, CGEIT + ITIL Foundation + GAMP 5 knowledge or certification + CBCP (Certified Business Continuity Professional) or equivalent The base salary range for this role is $152,000 to $190,000. 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_

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_

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_

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_

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** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. 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_