Sumitomo Corporation 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. **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 Overview** We are currently seeking a dynamic, highly motivated, experienced individual for the position of **Senior Manager, Meetings and Events** that will function as primary liaison for internal meetings and events. **Job Duties and Responsibilities** + Lead strategic and tactical development of internal meetings execution to ensure strong engagement with stakeholders + Manage and negotiate any hotel needs, congress needs, destination management company (DMC), and all third-party contracts for all congresses and meetings + Coordinate program details and produce a project timeline / working agenda that outlines all program deadlines and requirements + Conduct regularly scheduled meetings with third-party agencies and stakeholders throughout planning process and program to communicate registration, status meetings, and debriefs + Maintain proactive, positive, open line of communication with stakeholders to ensure understanding of expectations and satisfaction + Partner with third-party agencies to arrange their services + Monitor attrition dates and cancellation policies to ensure contracted services are executed within parameters + Work with finance to complete billing and invoicing + Manage third-party agencies program budget. Track and report expenses to stakeholders and communicate changes on a consistent basis + Handle multiple projects/demands effectively + Onsite meeting management and coordination + Responsible for forecasting, negotiating and reconciling all meeting related expenses + Monitor and track invoices and expenses ensuring expenses are within budget + Manage relationships with vendors including meeting planning vendors, production companies and any other vendor associated with the meeting + Collaborates with Marketing, Sales, and Medical Affairs to define exhibit and convention objectives. Serves as liaison with third-party company **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 decisions 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 **Education and Experience** + Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline + Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech or pharmaceutical industry + 3-5 years of meeting planning experience in pharmaceutical/biotech industry + Must have experience managing meeting planning and vendor management + Experience with CVENT required + CMP certification, preferred The base salary range for this role is $167,200 to $209,000. 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. 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 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** + Lead on clinical studies and manage/provide training to team members when needed. + Contribute and implement statistical analysis plans; provide additional expertise in the + undefined + undefined + Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments. + Work closely with Biostatistics to create analysis specifications following the instructions + undefined + Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's + undefined + Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS. + Interact with Statisticians and other clinical teams, perform ad hoc analysis and generate + undefined + Help identify issues and initiates resolution of the problems. + Act as a liaison between statistical programming, subcommittees and project teams as + undefined + May serve as an external spokesperson for the Statistical Programming Organization. + Create/acquire tools to improve programming efficiency or quality. + Establish monitoring of data transfers for ongoing trials to identify study conduct or data + undefined + Experience with integrated summaries (ISE/ISS) and Clinical Study Reports. + Perform other duties as assigned. **Key Core Competencies** + Support End-to-End Statistical Programming using SAS + Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc. + Executing Pinnacle 21 Checks + Knowledge about CDISC and Regulatory Guidelines + Demonstrate coaching skill to mentor Statistical Programmers + Demonstrate ability to collaborate with cross-functional teams such as Biostatisticians, Clinicians, Data Managers etc. **Education and Experience** + Minimum 10 years or equivalent Pharmaceutical/Biotech programming experience with two years of people management experience. + Ability to use professional concepts to achieve objectives in innovative and efficient ways. + FDA submission experience is a must. + Solid knowledge of CDISC standard (SDTM & ADaM). + Strong SAS programming and Statistical background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat. + Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus. + BS/MS or equivalent in Statistics, Math or Scientific Discipline The base salary range for this role is $155,360 to $194,200. 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. We are currently seeking a dynamic, highly motivated individual for the position of **Multi-Specialty Portfolio Specialist.** In this field-based role, the **Multi-Specialty Portfolio Specialist** will focus on achieving sales goals within primary care, urology, and the women's health therapeutic area in an assigned geographic territory. This individual will have a proven record of success within specialty biopharmaceuticals. They will be highly collaborative, tactical, energetic and thrive in a nimble organization. The **Multi-Specialty Portfolio Specialist** will demonstrate a sense of urgency to prepare and successfully execute a new product launch plan for their assigned geography. The **Multi-Specialty Portfolio Specialist** will drive results that are consistent with the company's goals, mission, and values. **Job Duties and Responsibilities** Deliver Results + Consistently meet or exceed sales objectives by leading and implementing effective sales strategy in an ethical and compliant manner + Demonstrates resilience and consistent ability overcome obstacles to achieve objectives + Consistently demonstrate SMPA Values Business Planning and Execution + Develop and execute an effective business plan aligned to sales strategy to achieve sales results + Prioritize and call on the appropriate customers at the optimal frequency to change prescribing behaviors + Demonstrate effective pre-call planning prior to HCP engagement to establish a clear purpose for the sales call Impactful Selling + Move customers along the adoption continuum by driving market share growth + Demonstrate two-way dialogue with customer interactions by employing selling skills to generate dialogue, identify customer needs and active listening + Effectively utilize patient type selling with approved messaging and resources Infinite Mindset + Deploy growth mindset daily + Focus on opportunities not limitations + Expect success **Key Core Competencies** + Has a proven, consistent track record of exceeding sales goals in assigned geography or relevant experience. + Proven to be successful in all aspects of selling, i.e., clinical expertise, selling skills, and an in-depth understanding of the local ecosystem or relevant experience. + Understands, analyzes, and effectively presents scientific/technical details and marketing materials. + Proficient knowledge and understanding of the payer landscape including commercial, Medicaid, and Medicare or relevant experience. + Demonstrates the ability to analyze complex data to develop strategic and actionable business plans to deliver sales results. + Candidates must have excellent communication & organizational skills and be proficient with technology platforms and business hardware/software. **Education and Experience** + Bachelor's Degree is required, preferably in Business or Life Sciences. + Generally, the **Portfolio Specialist** will require 3 - 5+ years of pharmaceutical sales experience and/or relevant experience. Demonstrated mastery or the aptitude to learn, product and disease state knowledge. + Travel within territory is required, which may include both car and overnight air travel depending upon territory. + Some national travel to corporate headquarters, training, product theaters and sales meetings is required on a periodic basis. + Work hours may include meetings scheduled outside of normal working hours. The base salary for the Portfolio Specialist is $108,000 - $135,000.00. 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: + Act as the primary liaison to the organization, representing your clients needs and driving alignment with broader capabilities and initiatives. + Consult on strategic business priorities to identify solutions that offer the highest value and greatest impact. + Facilitate collaboration across stakeholders and teams to ensure seamless execution, prioritization, and follow-through of efforts. + Monitor progress and outcomes to ensure solutions are delivering value and meeting the needs of stakeholders. + Educate business partners in BI tools, capabilities, and data literacy concepts to foster a culture of data-driven decision-making. + Help define, refine, and translate business needs into data questions, metrics, and solutions that align with Operational goals. + Identify overlapping business needs and opportunities to scale solutions across teams for greater efficiency and impact. + Serve as a change agent - helping leaders adopt new ways of thinking about and using data through consultative guidance and empathetic support. + Stay informed about the IT roadmap and upcoming initiatives to proactively guide business partners and manage expectations. + Maintain clear, concise documentation of needs and decisions. **Knowledge and Skills** + Proficient in tools such as Excel, PowerPoint, and data visualization platforms (e.g., Tableau, PowerBI); not expected to be a technical expert but comfortable working within a business intelligence ecosystem. + Strong understanding of how data and analytics support business operations, particularly within underwriting domains. + Strategic thinker with strong problem-solving skills and a systems mindset; able to ask the right questions, synthesize insights across lines of business, and guide stakeholders through ambiguity. + Solid understanding of financial services product offerings, distribution channels, and the competitive landscape, with the ability to translate external trends into internal strategy + Familiarity with one or more operational domains (e.g., Pharma, Biotech, or Life Science etc.), with the ability to tailor analytics solutions to the unique needs and workflows of each area. + Proven ability to communicate the strategic value of data and analytics, and to guide cross-functional stakeholders in developing and adopting data strategies across business units. + Exposure to business intelligence concepts such as KPIs vs metrics, data governance, or data literacy. + Excellent communication and interpersonal skills, with the ability to build trust, influence without authority, and communicate complex concepts clearly to non-technical audiences. + Excellent documentation skills with the ability to clearly capture and communicate business needs, statuses, and outcomes to both technical and non-technical audiences. + Strong organizational skills and ability to manage multiple initiatives while maintaining attention to detail and a focus on value. + Ability to navigate complex stakeholder environments and drive alignment across diverse perspectives. + Experience in supporting change management efforts or influencing adoption of new tools, processes, or cultural shifts. + Adept at identifying themes, synthesizing information, and drawing meaningful insights from conversations and data. **Education level and/or relevant experience(s):** + 8+ years of experience in business intelligence, internal consulting, relationship management, or strategy-focused role + 3+ years of demonstrated ability to think strategically, connect solutions to business outcomes, and guide stakeholders through ambiguity. + 2+ years of experience delivering business updates to leadership, including crafting concise executive summaries for senior stakeholders. + 2+ years of experience supporting a large-scale enterprise initiatives. The base salary range for this role is $153,200 to $191,500. 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 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. SMPA is currently seeking a dynamic, highly motivated, and experienced individual for the position of **Analyst, Contract Operations** . This position requires a detailed understanding of the life science industry specific to Contract Operations. Decisions made in this position affect company sales, pricing discounts, and best price implications. This role also facilitates working relationships with both internal and external customers. The role is responsible for managing the following: GPO account membership load and hierarchy setup across Hospital, LTC and Oncology GPO's, validating and aligning pricing tier structures, processing of volume-based rebate structures, trouble-shooting transaction types, and aligning membership requests based on class of trade designations in Model N system of reference. Maintain data integrity of customer information and develop and implement business rules and procedures for customer segments. Reconcile and resolve customer data and membership discrepancies. **Job Duties and Responsibilities** + Perform day-to-day off-invoice and segmented rebate processing. Able to communicate and resolve discrepancies with customers in situations while maintaining positive relationships and professionalism. + Perform contract creation and ensure detailed accuracy within contract management system. Input all relevant contractual information for contract set-up (i.e. contract entity, term dates, pricing concessions, and member eligibility). + Attention-to-detail communication with external customer base as it relates to multiple components (i.e. contract pricing, and membership eligibility). + Design system reports and help develop any future new system off-invoice requirements. Perform detailed analytics of customer data for internal and external partners as well as customer submitted off-invoice data. + Perform chargeback volume analysis for reporting to upper management. + Work collaboratively with internal as well as external partners for discrepancies in off-invoice resolution processing. + Assist Government Pricing department on a monthly/quarterly basis on off-invoice reconciliations as it relates to government pricing calculations. + Work with IT to resolve transactional invoice technical/business system issues. + Performs other responsibilities as assigned. + Maintain service standards in processing data and proactively advise management of issues. + Maintain status reports and update numerical information in spreadsheets. + Conduct yearly analysis or ad hoc of SOP's and Work Instruction documents as it relates to department business processes and able to update those documents accordingly with streamlined enhancements. + Adhere to SOP's, Work Instructions, and SOX control documents as they relate to department business processes and update documents as needed. + Identify and recommend improvements in business procedures and outcome. + Investigate, analyze information, and resolve business questions and disputes by applying information from various data sources, business rules and system processes. + Perform other responsibilities as assigned. **Education and Experience** + Bachelor's degree or AD preferred The base salary range for this role is $65,520 to $81,900. 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 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 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** The **Associate Director, Sales Analytics - Prostate Cancer** position will lead business insights and field strategy for the commercial organization as it relates to the Prostate Cancer sales team. 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 - Oncology** and will be an integral part of the Commercial Analytics team. This position will partner with sales, 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 sales and market access offerings by developing insights from data/information and translating insights to shape field strategy and decisions. + Develop relevant and compelling insights presentations for key stakeholders while adapting communication style based on audience. + Develop strategic partnership as the main point of contact for the Prostate Cancer field leadership team and support for the Market Access National Corporate Accounts and Strategic Account Management teams. + Develop and prioritize key business questions with the cross-functional support of sales, finance, market access and other partners in the organization. + Manage development, delivery of strategic field KPIs and supporting metrics for the monthly field leadership business reviews. + As part of the Orgovyx brand planning process, support the development brand-specific situational analysis, participate in tactical planning, and partner with sales and marketing to create meaningful KPIs. + Oversee analytic ad hoc project requests related to Prostate Cancer sales team. + Support the finance forecasting process by providing key insights and assumptions in partnership with commercial leadership. + Lead alignment, targeting, call planning, and segmentation projects for Prostate Cancer field team, in partnership with other Commercial Analytics leaders. **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). + Excellent team player and collaborative skills. + Strong project management skills and managing external vendors/ deliverables within tight timelines. + Strategic partner to multiple cross-functional stakeholders. + Proven success in developing analyses with Business Intelligence tools and methods (e.g., Tableau, Qlikview, SQL). + 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 sales or marketing experience preferred. + Previous sales analytics experience (with SQL) preferred. 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 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. **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 managing company's HR applications technology, 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, compliance requirements, and strategic 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 data governance initiatives. **Key Responsibilities** Systems Management & Architecture + Serve as the technical and functional lead for **Workday** and other HR-related applications. + Design and maintain the **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. + **P** **rim** **ary liaison** for Workday IT support, helpdesk, and enhancement requests. + Provide functional guidance and mentorship to HRIS analysts or other team members. Data, Reporting & Compliance + Manage HR data governance, ensuring accuracy, consistency, and compliance with data privacy and audit requirements. + Develop and maintain reports, 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's degree 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. + 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. 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 **Associate Director, Commercial Data Management** . This high impact role requires a strategic and technically skilled person to support our growing Commercial Data Management (CDM) function, serving as a key liaison between Commercial stakeholders, data engineering, vendors and partners, ensuring the integrity, accessibility, and strategic use of commercial data assets. **Job Duties and Responsibilities** + Act as a strategic partner and advisor to business stakeholders for acquiring and leveraging data for planning, tracking and decision making + Gather/translate business data requirements into technical specifications for the data engineering team + Oversee master data sets (Customer, Product, Payer) and ensure data quality, accuracy, and compliance + Lead data integration projects and collaborate on enhancements and functionality + Lead efforts to provide effective access to data for non-technical users through the use of database views, visual tools and tool plug-ins + Monitor and enforce data governance standards, policies, and procedures + Manage data operations process while leveraging data quality procedures and tools + Utilize and enhance the data quality framework to ensure accurate and complete data before it goes to the end users + Manage the targeting and alignment data. Partner with sales operations in the quarterly development of targets and alignment. + Manage the data inquiry process. Leverage vendor resources to address inconsistencies in the data. Work with data providers to resolve issues as needed. + Respond to ad hoc data inquiries and field investigations; support field force training **Education and Experience** + Bachelor's degree, preferably in ... + Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's) years of relevant experience in biotech, pharmaceutical, or healthcare industry, including 5+ years of experience in Commercial Data Management and/or Analytics + Prior experience must include managing data from distribution partners include specialty pharmacies and specialty distributors and experience working with data warehouse platforms (Oracle, Snowflake, Databricks) and MDM processes + At least 3 years' experience managing data vendors and working in cross-functional environments + Proficiency in SQL, BI tools such as Tableau, Excel, and other data visualization/reporting tools + Excellent communication, stakeholder management, and problem-solving skills + Strong knowledge of CRM platforms (Salesforce, Veeva), syndicated data (IQVIA & Symphony sales and claims data, MMIT) The base salary range for this role is $153,200 to $191,500. 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 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, Service Delivery Engineer. This person should have an understanding of Good Manufacturing Practices (GMPs) and experience providing technical support in highly regulated or pharmaceutical/biotech facilities. A strong customer service mindset is the key to succeeding in this role. This person will play a lead role in ensuring our onsite Team is providing outstanding customer support, enhancing our Meeting Support program, and assisting in providing support at a L3 level, including to our Executive Leadership Team. This is **an onsite** opportunity, with the ability to work some days remote.. **Job Duties and Responsibilities** + Provide Tier 2 and Tier 3 support to our users via **onsite,** phone, email, and computer chat. + Field incoming requests to Information Technology via Service Management (ITSM) tool assignment group, e-mail, instant message, and in person to ensure courteous, timely and effective resolution of end user issues. Independently manage outstanding response to customers and management of your work ticket assignment. + Investigate and resolve incidents by troubleshooting issues and identifying root causes including installing and upgrading software, provisioning and supporting hardware, and configuring systems and applications in person or utilizing remote desktop control tools, as required. + Evaluate and maintain documented resolutions and analyze trends for ways to prevent future problems. + Provide Meeting Support to Executive Level team members utilizing outstanding customer service and strong experience supporting MS Teams conference rooms equipment. Crestron equipment experience a plus. + Alert the Service Delivery Team and Management to emerging trends in incidents. + Identify opportunities for automation, and assist with the development of automation through systems and processes to address those opportunities + Responsibilities will focus on technical support for a multi-location corporation (remote and in person as required, including travel to Sales Meetings, if needed.) + Supporting and troubleshooting equipment in corporate offices and for end users. + Configure, maintain, and troubleshoot VOIP systems, including Microsoft Teams Voice, and manage legacy POTS lines for reliable telephony services. + Collaborate with network teams to ensure QoS for voice traffic, perform number porting, and maintain compliance with E911 regulations. + Perform preventative maintenance, including checking and servicing of workstations, printers, mobile devices, and peripherals (as defined by scope) + Abide by SLAs (Service Level Agreements) to manage end-user expectations + Perform post-resolution follow ups to help eliminate future requests + Available nights and weekends for on call rotations or emergencies + Travel 10% to other offices when required + Ability to lift up to 50 lbs when required. + Fluent English **Key Core Competencies** + Build relationships with key internal and customer contacts + Maintain a customer service first mindset + Attentive problem solver + Strongly motivated, well-organized, and shows professional initiative. + Keen ability to recognize trends in incidents. + Ability to clearly present complete problem details and propose recommended solutions to management. + Understanding of importance of and compliance to Security and Compliance in IT environments. + Skilled in Microsoft Teams Voice administration, SIP protocols, and legacy telephony systems. + Ability to optimize voice traffic across LAN/WAN and ensure adherence to telecom regulatory requirements. + Effectively maintain time management and prioritization responsibilities across operational support and project deliverables + Understanding of MS Teams Meeting Room equipment + Experience supporting Saas and Cloud Based applications **Education and Experience** + BS in Information Technology or related field + 5+ years of experience working within a GxP or highly regulated engineering environment. + Experience working with multi-tiered ticket handling/resolution systems + Knowledge of basic computer hardware, including Lenovo Laptops and docking stations. + Experience with desktop and server operating systems, including Windows 11 and Server 2000+ Applications: Office 365 expertise, Active Directory, OKTA, ability to learn new applications quickly + Takes ownership of assignments, can work both independently and as part of the team. + Ability to work in a fast-paced and challenging environment. + Excellent organization skills with the ability to manage multiple tasks simultaneously. + Exceptional written and oral communication skills + Ability to work responsibly with minimal supervision and with a sense of urgency while maintaining the proper judgement on when to inform management on an issue and escalate concerns or customer escalations. + Knowledge of ITSM tool, preferably ServiceNow, for Incident and Problem management tracking. + Experience working with Microsoft 365 and Intune. + Experience working with Active Directory and Azure Active Directory for user and group management. + Experience working with Intune for device management + Some familiarity with Okta or other forms of IdP (Identity Provider). The base salary range for this role is $104,960 to $131,200. 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** 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. **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Medical Director, Clinical Development - Oncology** . The medical director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators and key opinion leaders. **Job Duties and Responsibilities** + Lead and demonstrate ownership of the design and implementation of a clinical development program or programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues. + Oversee project-related education of investigators, study site personnel, and study staff. + Responsible for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of safety and efficacy data. + Present at scientific, medical, and regulatory meetings globally. + Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL's, and patient advocacy groups. + Contribute to company's planned regulatory filings including authoring clinical sections for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators, and internal stakeholders. + Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives. + Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards. + May participate in or lead clinical development contributions to due diligence or other business development activity. + As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies. + Participate in meetings and committees of parent company or other affiliates. + Establish collaborative and productive relationships with the parent company, internal/external partners, and relevant affiliates. + Work in close collaboration with the late-stage development group. + Perform other duties as requested. **Key Core Competencies** + Ability to run a complex clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols + Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team-oriented, and decisive + Able to lead through influence + Excellent communication and presentation skills are essential. + Identify the key competencies or attributes required to excel in the role. + Examples may include problem-solving, teamwork, communication, etc. + Highlight any specific qualities or traits that are important for success in the role. + These could include attention to detail, adaptability, creativity, etc. **Education and Experience** + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD required + Completion of a residency program strongly preferred + Completion of a subspecialty fellowship is desirable + Experience in blood cancers or solid tumors desirable + At least 3 years of pharmaceutical drug development experience required. The base salary range for this role is $236,100 to $295,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

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_