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Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This position requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs.. This role will also contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA submissions, working knowledge and experience in document management systems, relevant therapeutic areas, regulatory requirements, and other aspects of drug development (eg, nonclinical, pharmacokinetics, biostatistics). Responsibilities<ul><li>Write critical, complex clinical and clinical pharmacology documents (eg, pivotal Phase 3 CSRs, NDA/BLA/MAA submission documents, and briefing books) with minimal input from functional area experts; Ensure key messages are clear and consistent within and across documents</li><li>Critically review documents produced by other writers for scientific content and alignment with company position, clarity, accuracy, and consistency</li><li>Contribute strategically and scientifically at the study team level including recommendations for and review of data outputs for collection of specific data, and support the authoring of documents for filings or responding to health authority requests; Proactively advise study teams regarding regulatory requirements and ICH guidance for clinical documents</li><li>Participate in initiatives within the Global Regulatory Writing Group to identify process improvement opportunities, potential collaborations and drive changes as needed.</li><li>Assess resource requirements, proactively identify issues and solutions, and contribute to the development of timelines and processes</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>PhD in relevant science field preferred</li><li>Master's Degree in relevant science field preferred</li></ul>Experience Qualifications<ul><li>4 or More Years of experience as a medical writer with a graduate degree (Doctorate preferred) in a relevant science field</li><li>7 or More Years of experience as a medical writer with a Bachelor's degree in a relevant science field</li><li>Submission document writing experience required</li></ul>Travel Ability to travel up to 5%. In-house/remote office position that may require domestic/global travel. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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Associate Director, Regulatory Writing

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs Labeling position will provide Regulatory support for global labeling projects. Under the direction of the labeling leadership, the manager will develop, review and revise labeling for FDA submission, create and modify Structured Product Labeling for FDA submission, complete electronic drug listing, track and archive affiliate labeling for global products and review proposed labeling from affiliates. Responsibilities<ul><li>Provide Regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes. Review new labeling for accuracy and consistency with CCDS.</li><li>Create/modify labeling in Structured Product Label (SPL) for FDA submission Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents Identify changes needed for FDA- approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements</li><li>Track global affiliate labeling for global products including timelines for submissions and approvals, and documentation for deviations and deferrals Archive local affiliate labeling in central repository</li><li>Working with RA and RO representatives develop timelines for development of CCDS and USPI for new products</li><li>Review proposed labeling from global affiliates for consistency with CCDS Working with other functional representatives, develop draft responses to Regulatory Authority letters regarding labeling, both US and worldwide, as appropriate</li><li>Develop and maintain tools/lists that support labeling working teams, including LRCs (US) and CDS development teams (global)</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>Master's Degree in Life Sciences preferred</li></ul>Experience Qualifications<ul><li>4 or More Years direct regulatory affairs experience.</li><li>4 or More Years in the biopharmaceutical industry specifically RA Labeling preferred</li><li>Working knowledge of laws, regulations and guidelines</li><li>Applied knowledge of FDA labeling requirements</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Labeling

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations. The role is primarily responsible for Operational Study Strategy and Study Execution and in addition may have the responsibility of managing 3 or more direct reports. Responsibilities: Study Management and Leadership:<ul><li>Has primary accountability for operational study-level timeline, cost, and quality deliverables.</li><li>Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent.</li><li>Lead the creation of the cross functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP including activities conducted by CROs and vendors.</li><li>Provide operational input into study protocol profiles, final protocols and amendments</li><li>Lead document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.</li><li>Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.</li><li>Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.</li><li>Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process.</li><li>Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure actions are taken (at the study team level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies.</li><li>Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.</li><li>Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.</li><li>Proactively assess potential risks to the study and propose mitigation plans.</li><li>Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.</li><li>Ensure study budget is reconciled with Finance on an ongoing basis.</li><li>Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).</li><li>Ensures trial master file is complete and accurate for assigned stud(ies).</li><li>If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned clinical study and responsible for leading the cross-functional study team, project managing and coordinating with internal stakeholders to ensure cross functional integration and delivery of study team plan and milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.). The study team leader will ensure meeting logistics, agenda and minutes are in accordance with DS standards.</li></ul>CRO, 3rd Party Vendor Management and Oversight:<ul><li>Responsible for the oversight, performance and management of CROs and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.</li><li>Responsible for ensuring that the Clinical CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc.) as per study plan.</li><li>Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.</li><li>Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc.).</li><li>Review CRO-generated reports such as monitoring visit reports, protocol deviation reports, and analysis of site metric reports. Identify areas of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead. Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.</li><li>Conduct and/or oversee the CRO oversight monitoring visits (CROOM visits) as outlined in the CSOP.</li><li>Coordinate all operational activities under the guidance of the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after database lock.</li><li>Oversee CRO study close-out activities (including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed.</li></ul>Knowledge Management/People Management:<ul><li>This position may require the supervision of direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will:</li><li>The supervisor should coach and guide their direct reports in support of their development needs, ensure individual development plans are in place, and facilitate conflict resolution on their behalf.</li><li>Support Department in codifying existing knowledge and best practices; prepare training in area of expertise. Make recommendations for areas of improvement and innovation (study, or departmental level). Educate the team on adherence to SOPs, GCPs and on best application of operational tools and processes. May represent the organization as a prime contact for technical matters of significant complexity with possibility of leading a cross-functional initiative or workstream.</li><li>Manage all employee-related activities throughout the year, including performance management and development.</li><li>Identify and communicate the skills, behaviors and experiences required to develop employees.</li><li>Set goals, reviews performance and provides feedback on a regular basis.</li><li>Assist or Lead training SOPs, GCPs, operational systems, etc.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Bachelor's Degree in a Life Sciences field and a minimum of 7 years of relevant experience required</li></ul>Experience: <ul><li>Experience in clinical operations methods and processes in industry setting. required</li><li>Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred</li><li>Familiarity to a Japan-based organization is desirable.</li></ul>Travel:<ul><li>Ability to travel up to 10% In-house office position that may require travel (global).</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Clinical Operations

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Work in an exciting and challenging legal environment by independently providing innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products and to specific assigned business functions in the Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs, Sales, Marketing, Market Access, etc.) including, but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is required. Provides appropriate counsel and direction to other members of the Legal Affairs Department as well as serving as a mentor in order to foster their professional growth and development as well as their achievement of Company and/or departmental expectations and goals as identified by senior management. Responsibilities - Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products. Acts as legal advisor for assigned corporate business and functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs) as well as DSI employees performing Global roles in the United States (such as Global Marketing, Global Medical Affairs). For these areas, acts as lead attorney for that area providing legal advice and support for the business aspects of those functions. Prepares legal documents such as contracts, correspondence (e.g., to regulatory agencies), both independently and for review, approval, and use by Legal Affairs management. Independently negotiates contracts and other issues with third parties (vendors, etc.). Manages, as assigned, outside lawyers and contracted legal counsel assigned to specific corporate business or functional areas of the Daiichi Sankyo Oncology Business Unit and US Oncology Business Division of the Company. [Specific assignments to be determined by direct manager of the role.] - Creates, implements, and presents training programs and materials on legal issues for various departments. Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same. - Leads cross-functional project management teams set up to address mid-sized to large Company-driven initiatives or special projects-internal to the Company as well as project involving external business partners and/or other entities. The result of such initiatives may include creating corporate-level policies, guidance documents (i.e. standing legal risk analyses), and training of Company employees. - Monitors current developments in several key legal areas and provides Senior Management and other business leaders with updates regarding same (including Legal Affairs Department colleagues). Works independently and, as appropriate, in collaboration with other departments in developing, implementing and presenting training materials on various legal issues pertaining to assigned business areas. Such training materials may be presented to functions supported by this position (or by them) but would also be available for use by the Legal Affairs Department generally. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree required - JD from Law School of recognized standing, and Bar Admission in NJ (direct admission or eligible for limited in-house licensing in NJ.) required Experience Qualifications - 7 or More Years of post-law school experience required - 4 or More Years experience in regulatory, compliance, and legal matters relating to investigational products, product promotion, scientific exchange, and disease state communications (including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, state and federal data privacy laws, and product liability laws) required - 7 or More Years pharmaceutical industry experience, particularly supporting specific assigned products and business areas in contracting, general legal advice, policy development and/or review, etc. in specific business support functions in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions preferred - Experience with Veeva Vault PromoMats preferred - Experience with pricing and Market Access preferred - Experience with Government Affairs preferred Licenses and Certifications - Eligible to practice law in the state of New Jersey (either licensed in NJ or limited in-house license) and maintain such license in good standing at all times. required Travel Ability to travel up to 5%. Occasional travel required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Assistant General Counsel Commercial

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager FP&A position is an integral part of the finance team supporting our applicable business partners and is responsible for providing financial leadership & guidance to achieve company objectives. This position will need to have a collaborative and teamwork mindset to bring value to our business partners and organization. The Manager FP&A will lead the Annual Financial Plan, Quarterly LE Forecast, & monthly reporting processes for assigned areas. This role will be responsible for finding novel approaches to solving problems and focus on improving processes across the organization. The person will be required to demonstrate strong interpersonal skills to build and manage effective working relationships throughout the organization. Responsibilities - Financial Plan Latest Estimates (LEs): Leads the Annual Financial Plan LE Forecast cycles. Collaborates with business partners to monitor revenue expense performance indicators to provide guidance and insight into the financial forecasts. Develops proposals to mitigate / enhance risks and opportunities with sufficient lead time. - Management Reporting: Prepares monthly reporting package working with business partners on reasons for any variances and implications on business performance. Works with Director of FPA to streamline and improve reporting to offer management insights to make more informed business decisions. Develops KPI metrics and other tools to evaluate performance across the business. - Business Partnering: Develops effective working relationships with business partners and influences strategic decisions to align to company objectives. Develops strong business knowledge of the Functions to help find synergies efficiencies across the organization. Challenges the status quo in an appropriate way to find more optimal and cost-effective approaches that are aligned to our strategy. - Change Management Special Projects: Responsible for developing improving processes to enhance efficiencies, as well as offering novel solutions perspectives aligned with company goals. Accountable for any ad hoc special projects as they arise. May be responsible for overseeing and developing staff. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree in Accounting, Finance, or related field required - MBA in Finance preferred Experience Qualifications - 4 or More Years experience in accounting and/or Financial Planning and Analysis-related work, and/or pharmaceutical/R&D experience required Licenses and Certifications - Certified Public Accountant (CPA) preferred Travel Ability to travel up to 10% potential limited travel for accounting conferences/trainings, etc. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Financial Planning & Analysis

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Effectively liaise, negotiate and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals. Responsibilities<ul><li>Liaise, negotiate and orchestrate meetings and teleconferences with FDA; strategize and plan for FDA meetings; capture all communications via contact reports.</li><li>Prepare, assemble and publish all regulatory documents (NDAs, INDs, Annual Reports, Safety Updates, Quarterly Reports) in paper and electronic format.</li><li>Participate in global product team meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.</li><li>Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.</li><li>Mentor/instruct and provide guidance to direct reports.</li><li>Review and interpret regulatory guidelines.</li><li>Review RA and related documents for approval.</li><li>Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred</li></ul>Experience Qualifications<ul><li>7 or More Years in the pharmaceutical industry</li><li>4 or More Years in regulatory affairs, NDA, sNDA, BLA filing to FDA</li></ul>Travel Ability to travel up to 30% In-house office position that may require occasional travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, US Regulatory Affairs Strategy

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ownership and management of these processes for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and policy adaptation within the support teams and across business units. The GSM is responsible for the training, performance tracking, and reporting of these processes, and works across all applicable functional areas within IT to ensure processes are implemented, followed, and aligned with the business and Global IT strategy. The GSM is responsible for managing multiple vendor relationships and for providing oversight of the relevant support teams for their domain area. This includes managing service contracts, change management, and SLA management. The GSM partners with vendors, businesses, and IT partners to manage the end-to-end vendor lifecycle. In addition, responsibilities include analyzing and identifying opportunities for process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT Services contact in their respective domain areas for support requests and inquiries. The GSM has a strong technical background, excellent communication skills, is well organized, and an outstanding collaborator. Responsibilities - Perform service-design responsibilities for projects and major changes, participate in RFP-related activities/reviews. - Partner with application teams and vendors, when appropriate, to deliver projects. Partner with other IT leaders across the organization and champion the day-to-day operation of the lifecycle of Incident, Problem, and Change Management. Communicate and interface with matrix teams, IT leadership, business leadership, and external vendors/partners to execute responsibilities. - Responsible for review, approvals, categorizing, prioritizing, of change requests. - Analyze Service Requirements in business to define/revise service levels. Facilitate regular business reviews with all partners and provide performance summary analysis, and gap analysis to ensure that the right tools and processes are available to deliver the best customer experience. - Manage, report, and communicate on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve it. Establish KPIs for systems and services, measure and report the results. Support IT Senior Management by maintaining high service standards. - Analyze and Report on partner performance across all defined metrics and identify trends, opportunities, issues, and successes. Work with vendors and businesses to improve performance through creative process improvement and implementation of new strategies. Oversee relationship with vendors in adherence to KPIs. - Providing coaching and training to Support teams. Ensure applicable support team members maintain alignment to standards, following GxP guidelines meeting documentation needs in support of all internal and external audits. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Bachelor's degree in computer science, Life Science, Engineering, Information Technology or a related discipline or equivalent work experience is required Experience Qualifications - 5 years of relevant global technology services and operations in the life sciences industry required - Experience in the structure, development, migration and management of IT services preferred - Experience with support of global systems and users, including a working knowledge of pharma business processes preferred - Experience in global business and supplier relationship management preferred - Experience managing, enhancing, and supporting global, enterprise grade technology services including development and structuring of third-party service agreements preferred - Experience managing multiple vendors and service providers under a Service Integration and Management (SIAM) model preferred - Experience supporting and participating in regulatory agency inspections, partner audits, and QA inspections preferred Travel Ability to travel up to 10% Travel to DSE, DSJ and other DS locations which will include overnight travel. Ability to travel to the US, EU and Japan. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Global Service Manager, Global Applications and Services, GDX-3

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ownership and management of these processes for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and policy adaptation within the support teams and across business units. The GSM is responsible for the training, performance tracking, and reporting of these processes, and works across all applicable functional areas within IT to ensure processes are implemented, followed, and aligned with the business and Global IT strategy. The GSM is responsible for managing multiple vendor relationships and for providing oversight of the relevant support teams for their domain area. This includes managing service contracts, change management, and SLA management. The GSM partners with vendors, businesses, and IT partners to manage the end-to-end vendor lifecycle. In addition, responsibilities include analyzing and identifying opportunities for process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT Services contact in their respective domain areas for support requests and inquiries. The GSM has a strong technical background, excellent communication skills, is well organized, and an outstanding collaborator. Responsibilities - Perform service-design responsibilities for projects and major changes, participate in RFP-related activities/reviews. - Partner with application teams and vendors, when appropriate, to deliver projects. Partner with other IT leaders across the organization and champion the day-to-day operation of the lifecycle of Incident, Problem, and Change Management. Communicate and interface with matrix teams, IT leadership, business leadership, and external vendors/partners to execute responsibilities. - Responsible for review, approvals, categorizing, prioritizing, of change requests. - Analyze Service Requirements in business to define/revise service levels. Facilitate regular business reviews with all partners and provide performance summary analysis, and gap analysis to ensure that the right tools and processes are available to deliver the best customer experience. - Manage, report, and communicate on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve it. Establish KPIs for systems and services, measure and report the results. Support IT Senior Management by maintaining high service standards. - Analyze and Report on partner performance across all defined metrics and identify trends, opportunities, issues, and successes. Work with vendors and businesses to improve performance through creative process improvement and implementation of new strategies. Oversee relationship with vendors in adherence to KPIs. - Providing coaching and training to Support teams. Ensure applicable support team members maintain alignment to standards, following GxP guidelines meeting documentation needs in support of all internal and external audits. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Bachelor's degree in computer science, Life Science, Engineering, Information Technology or a related discipline or equivalent work experience is required Experience Qualifications - 5 years of relevant global technology services and operations in the life sciences industry required - Experience in the structure, development, migration and management of IT services preferred - Experience with support of global systems and users, including a working knowledge of pharma business processes preferred - Experience in global business and supplier relationship management preferred - Experience managing, enhancing, and supporting global, enterprise grade technology services including development and structuring of third-party service agreements preferred - Experience managing multiple vendors and service providers under a Service Integration and Management (SIAM) model preferred - Experience supporting and participating in regulatory agency inspections, partner audits, and QA inspections preferred Travel Ability to travel up to 10% Travel to DSE, DSJ and other DS locations which will include overnight travel. Ability to travel to the US, EU and Japan. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Global Service Manager, Global Applications and Services, GDX-2

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ownership and management of these processes for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct problem management meetings, and drive process and policy adaptation within the support teams and across business units. The GSM is responsible for the training, performance tracking, and reporting of these processes, and works across all applicable functional areas within IT to ensure processes are implemented, followed, and aligned with the business and Global IT strategy. The GSM is responsible for managing multiple vendor relationships and for providing oversight of the relevant support teams for their domain area. This includes managing service contracts, change management, and SLA management. The GSM partners with vendors, businesses, and IT partners to manage the end-to-end vendor lifecycle. In addition, responsibilities include analyzing and identifying opportunities for process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT Services contact in their respective domain areas for support requests and inquiries. The GSM has a strong technical background, excellent communication skills, is well organized, and an outstanding collaborator. Responsibilities - Perform service-design responsibilities for projects and major changes, participate in RFP-related activities/reviews. - Partner with application teams and vendors, when appropriate, to deliver projects.Partner with other IT leaders across the organization and champion the day-to-day operation of the lifecycle of Incident, Problem, and Change Management.Communicate and interface with matrix teams, IT leadership, business leadership, and external vendors/partners to execute responsibilities. - Responsible for review, approvals, categorizing, prioritizing, of change requests. - Analyze Service Requirements in business to define/revise service levels.Facilitate regular business reviews with all partners and provide performance summary analysis, and gap analysis to ensure that the right tools and processes are available to deliver the best customer experience. - Manage, report, and communicate on the global performance of owned processes.Monitor Service Quality and put proactive measures in place to improve it.Establish KPIs for systems and services, measure and report the results.Support IT Senior Management by maintaining high service standards. - Analyze and Report on partner performance across all defined metrics and identify trends, opportunities, issues, and successes.Work with vendors and businesses to improve performance through creative process improvement and implementation of new strategies.Oversee relationship with vendors in adherence to KPIs. - Providing coaching and training to Support teams.Ensure applicable support team members maintain alignment to standards, following GxP guidelines meeting documentation needs in support of all internal and external audits. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Bachelor's degree in computer science, Life Science, Engineering, Information Technology or a related discipline or equivalent work experience is required Experience Qualifications - 5 years of relevant global technology services and operations in the life sciences industry. required - Experience in the structure, development, migration and management of IT services. preferred - Experience with support of global systems and users, including a working knowledge of pharma business processes. preferred - Experience in global business and supplier relationship management. preferred - Experience managing, enhancing, and supporting global, enterprise grade technology services including development and structuring of third-party service agreements. preferred - Experience managing multiple vendors and service providers under a Service Integration and Management (SIAM) model. preferred - Experience supporting and participating in regulatory agency inspections, partner audits, and QA inspections. preferred Travel Ability to travel up to 10% Travel to DSE, DSJ and other DS locations which will include overnight travel. Ability to travel to the US, EU and Japan. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Global Service Manager, Global Applications and Services, GDX-1

Global Service Manager, Global Applications and Services, GDX-4

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support of the strategic development, oversight, and execution of global monitoring conduct across the DS portfolio. This position will serve to support the project plan of CRA Monitoring Oversight and Excellence and the CSOP as it relates to monitoring and CRO/vendor oversight. This is a highly collaborative and dynamic role within a fast paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and Central Monitoring. Responsibilities: CRA Monitoring Oversight Management:<ul><li>Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies and procedures, and the development and execution of monitoring activities that are outlined in the various study/CRO plans across the portfolio.</li><li>Ensure study-specific monitoring plans meet the above standards.</li><li>Review quality oversight plans that CRO CRAs have in place to ensure detailed escalation pathways are present.</li><li>Support monitoring process checks linked with CRA activities that require inclusion in the quality plan.</li><li>Responsible for monitoring the following CRA central oversight activities: Determine CROs compliance with monitoring plan for on-site and remote site visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)</li><li>Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip Report Review process.</li><li>Responsible for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation of action plans/mitigations which are brought to resolution.</li><li>Participate in/facilitate constructive change by identifying areas of improvement to support overall CRO CRA monitoring oversight and share findings with appropriate stakeholders/team leadership.</li><li>Collaborate on the development of monitoring plan templates including review and annotation of monitoring-related documentation.</li><li>Contribute to and support the oversight of the agreed RBQM strategy and ensure the strategy is in place for every study for CRAs to execute against.</li></ul>Metrics and Analytics:<ul><li>Ability to analyze data/metrics/key performance indicators to support vendor/CRO oversight of CRAs in clinical trials.</li><li>Contribute to KPI/metric development in collaboration with Strategic Vendor Oversight role and AD of CRA Monitoring Oversight and Excellence role</li><li>Support the model in place for DS Trip Report Review via reviewing analytics and metrics of MVR and CRO dashboards</li><li>Identify trends and escalate significant issues and findings in a timely manner.</li></ul>Study Operations Oversight Management:<ul><li>Contribute to the oversight of Qualification and Training of CRO staff especially as it relates to CRAs. Assist with creation and/or review of CRO and site training material as stated in the CSOP</li><li>Support and/or lead mitigation of CRO/vendor oversight findings.</li></ul>Additional Collaboration Opportunities:<ul><li>Support strategic and manageable site engagement in accordance with the RSEM and local country teams.</li><li>Collaborate with TMF lead and CRO Oversight leaders to ensure CRAs are updating appropriate systems.</li><li>Collaborate with Alliance and CRO CRA leadership on major study commitments including resolving any key issues identified.</li><li>Participate in or support internal audit and regulatory inspection activities related to site monitoring and sponsor oversight.</li><li>Contribute to the quality improvement of the study processes and other procedures and ensure sites are inspection ready.</li><li>Contribute to SOP updates.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education:<ul><li>Bachelor's Degree in related discipline, or equivalent work experience required</li></ul>Experience: <ul><li>4 or More Years 5+ years' pharmaceutical-industry experience, at least 3 of which is in a clinical operations CRA capacity. required</li><li>Relevant therapeutic experience and proven ability to learn new indications. required</li><li>Project Management experience and skill sets Macro Level oversight to gather input from external and internal stakeholders to make day to day decisions required</li><li>Ability to collaborate with a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required</li><li>Awareness of external competitive environment and operational practices required</li><li>Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required</li><li>Excellent written and verbal communication skills required</li><li>Willingness to travel both domestic and international required</li><li>Proven ability to develop successful collaborations with internal and external partners required</li><li>Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles required</li></ul>Travel: <ul><li>Travel up to 10% In-house office position that may require occasional travel (global).</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, CRA Monitoring Oversight and Excellence

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The Associate Director, RPM is considered an expert for all RPM activities and processes and is responsible for independently leading regulatory project management activities without additional guidance. The Associate Director, RPM provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in RPM processes and suggesting and integrating operational and procedural excellence best practice into RPM processes to enhance regulatory affairs capabilities. Responsibilities:<ul><li>Strong understanding and expertise of regulatory and the RPM role and understand key regulatory milestones and strategies.</li><li>Plans, coordinates, and reviews US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.)</li><li>Develops less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions and may be involved with preparation of more complex Module 1 documents if delegated by the USRA strategist</li><li>Works independently, predicts the needs for the GRL and GRT rather than being directed and helps drive coordination of regulatory activities.</li><li>Supports GRL with scheduling regulatory meetings, preparing agenda and tracking action items.</li><li>Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences.</li><li>Supports DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in preparation of regulatory sections.</li><li>Schedules rapid response team (RRT) meeting, creates response templates and coordinates processes for authoring and review of health authority response as appropriate.</li><li>Coordinates processes for core BB or FDA BB preparation, creates previous history section, drafts meeting request based on draft BB, and effectively participates in document review.</li><li>Works on additional regulatory activities per direction and strategic input from GRL and regulatory strategists.</li><li>Suggests and integrates operational and procedural excellence best practice into RPM processes and activities to enhance regulatory affairs capabilities.</li><li>Keeps current with regulatory and scientific regulations, guidelines and initiatives</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree required</li><li>Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred</li></ul>Experience Qualifications:<ul><li>4 or More Years relevant pharmaceutical experience</li><li>1 or More Years in regulatory Affairs required</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Regulatory Affairs RPM

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager, Sustainability will be a member of the company's Compliance Department and will report to the US Sustainability leader and will 1) manage the US Environmental Social Governance (ESG) Sustainability initiatives and partner with colleagues in Japan and at US affiliates to accomplish the company's ESG goals and 2) support various components of the company's corporate sustainability programs, including external disclosure reporting and ESG auditing. Responsibilities - Manage and Support US Environmental, Social, Governance (ESG) Sustainability Initiatives and greenhouse gas (GHG) and other ESG Metrics reporting and accounting. Working with management from each US affiliate promote awareness and support the global Corporate Conduct Charter. Create and maintain a responsibility matrix for purposes of tracking, collecting and reporting ESG data. Collaborate with appropriate departments to communicate the organization's environmental sustainability strategy, initiatives, progress, and achievements with colleagues, clients, stakeholders, and vendors. Track key performance indicators (KPIs) to identify progress on important sustainability metrics. Support the development of an environmental sustainability commitment statement, charter, and strategic plan to incorporate environmental sustainability into the organization's current framework. - Propose and promote sustainability initiatives supporting due diligence efforts under the company's human rights policy, and support data collection for global health management and access to healthcare programs. Develop e-learning and other educational programs to promote sustainability initiatives. - Assist leader in serving as liaison to Sustainability Department in Tokyo and within US affiliates including arranging and attending global sustainability meetings, developing quarterly reports, supporting the global sustainability websites and value report, arranging and supporting Environmental Health and Safety (EHS) audit requests. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree Engineering, Science or Sustainability related studies (preferred areas of study) required Experience Qualifications - 5+ years in ESG, Sustainability Management and GHG reporting and accounting required - 2+ years in Carbon/GHG metrics quantification and verification techniques and tools (GHG Scope 1, 2, and 3 emissions) required - 2+ years Sustainability/ESG disclosure under various common standards and frameworks (CSRD, GRI, TCFD, CDP, etc.) preferred - In Pharmaceutical industry preferred - Life-cycle assessment and Environmental Product Declaration development preferred - Speaks Japanese preferred Travel Ability to travel up to 10%. May require travel to Japan or Europe or between affiliates in the US periodically Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Sustainability

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position works with the Director, Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position oversees the creation of SAE Flow Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF activities. This position will interact with global study teams and represent PV operations in global interactions with CS Physicians and other study team members. This position will oversee and may engage within CSPV and with CROs to execute study start up processes. This level will handle problems requiring escalation from others and make decisions where appropriate and escalate any complex problems to the Director, Clinical Study Startup. This position requires strong organization and interpersonal skills and is able to work effectively with people at different levels of an organization and different cultures. Responsibilities<ul><li>Global PV Operations Representation on Clinical Study Teams: Represents PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act as PV Operations SPOC for study teams to ensure consistency and compliance across clinical study safety reporting and activities.</li><li>Global Management Strategy and Goals and Procedure Development: Assist Leadership to ensure compliance with protocol and internal/external standards. Identifies and drives strategy for process improvement initiatives. Reviews and provides input to SOPs, SOIs, and process guides.</li><li>Clinical Study Start-Up Documentation: Reviews all clinical study protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees the maintenance of the study specific SAE Flow Plan and collaborates with on behalf of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.</li><li>Electronic Data Capture (EDC) Responsibility: In conjunction with Data Management, establish the EDC strategy at the project and/or study level. Proactively identifies and manages risks at the project and/or study level as it relates to data capture and reporting. Establishes EDC standards for reporting to ensure quality and compliance in safety reporting.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)<ul><li>Bachelor's Degree Science degree required</li><li>Master's Degree preferred or</li><li>PharmD preferred or</li><li>RN degree preferred</li></ul>Experience Qualifications<ul><li>4 or More Years drug safety experience with technical experience in Electronic Data Capture and Safety Reporting. required</li><li>10 or More Years total pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred</li></ul>Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Clinical Study Startup, Clinical Safety and Pharmacovigilance

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product(s), and their approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. The current weighting includes a majority focus on Acute Myeloid Leukemia and a smaller focus on Iron Deficiency Anemia. Responsibilities:<ul><li>Achieves or exceeds sales objectives through promotion of product features and benefits to our key accounts: Academic Institutions, Hospitals, Infusion Centers, Nephrologists, Hematologists, Hospitalist, PCPs/IMs, Bloodless Surgery, buying groups, distributors and wholesalers in assigned territory. As a secondary base, Cardiologists, Endocrinologists and Rheumatologists.</li><li>Builds relationships with our customer base and key opinion leaders by personally visiting them, educating and influencing physicians and healthcare providers to prescribe Daiichi Sankyo, Inc.'s promoted products. Communicates products approved indications, advantages, features and benefits in both individual and group settings.</li><li>Analyzes customer needs and interests. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Carries out all sales and marketing programs. Maintains frequent correspondence with District Manager, co promotion team members.</li><li>Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products.</li><li>Participates in assigned training and completing outside reading. Keeps abreast of the products, applications, technical service, market conditions, competitive activities, advertising, and promotional trends through the reading of pertinent literature and consulting with colleagues. Attends and participates in all required meetings and training programs.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition and the marketing team to the District Manager.</li><li>Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21,'Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).'</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university):<ul><li>Bachelor's Degree required</li></ul>Experience Qualifications:<ul><li>4 or More Years overall pharma or healthcare related experience required</li><li>1 or More Years sales/marketing experience in the pharmaceutical or medical industry required</li><li>specialty, rare disease, and/or oncology experience strongly preferred</li><li>experience selling in complex environments preferred</li><li>Ability to travel up to 60%</li><li>Must have a valid driver's license with a driving record that meets company requirements.</li><li>Compensation and seniority level/title based on experience and qualifications</li></ul> In compliance with New York State Pay Transparency Law, the targeted base salary range for this position is $140,000 - $170,000. Please note, actual Compensation and seniority level/title will be determined based on experience and qualifications. Additionally, this position will be eligible for sales incentive and long term incentive based on performance. This position is also eligible for a company vehicle. Our benefits are part of what makes Daiichi Sankyo, Inc. a great place to work. We are proud of our longstanding commitment to the health and well-being of our employees and their families. We provide comprehensive health care benefits at a reasonable cost that are highly competitive in the pharmaceutical industry, as well as a Savings & Retirement Plan that includes a competitive company match plus retirement account deposits. To learn more about our benefits, please view the following link: https://careers.dsi.com/en-US/page/benefits Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law .

Oncology Territory Manager, Hematology and Supportive Care - NY East

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Payroll Head is responsible for leading and managing all aspects of Payroll for close to 2,000 employees and supporting the strategic payroll needs of a company poised for continued growth. These responsibilities will include management of all day-to-day payroll operations and activities for all US (multi-state) and Canada regions, ensuring compliance with company policies and statutory regulations. This position will be responsible for providing exceptional client service to the employee population, promptly addressing all related queries and concerns, and streamlining and improving our payroll and accounting processes to ensure "best in class" services. This person is instrumental in identifying strategic initiatives to support changing payroll tax regulations and supporting a complex array of tax and deduction calculations for existing locations and future growth and expansion, while managing a team of two in a fast-paced, rapidly growing environment. This role will be responsible for managing multiple vendor relationships, internal and external auditors and payroll and tax providers. The individual will also effectively interface and liaise with Human Resources, Finance & Accounting, Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory, accounting, tax and internal requirements. This person leads the timely and accurate delivery of payroll services and is responsible for maintaining the payroll system and related technologies. Responsibilities Manages all payroll supporting processes and controls which include: Provides audit support for internal and external auditors. Ensures State and federal agencies inquiries and other reporting requirements are met. Provides information to other internal departments where deemed appropriate. Develop project plans and manages the Year-End payroll project activities with the Payroll, HR, IT, and Finance members. Ensures all activities are performed according to the plan that results in the issuance of accurate and timely W-2 information to all employees and tax authorities. Maintaining and updating all processes and procedures for the Payroll department. Ensures that all internal controls and documented procedures are created and followed. Benchmark process by developing and maintaining payroll measurements and scorecards. Performs transaction error analysis and initiates best practices and process improvement activities were warranted. Functions as the primary contact for interactions with the primary payroll business partner vendor - ADP. Follows up directly with the partner to resolve any issues and escalates to executive management if required. Responsible renewing contract terms and reviewing and approving invoices according to the terms of the contract Oversees and direct staff to appropriately handle employee and other inquiries for the department. Manages and monitors the help desk support tool to ensure inquiries are timely and successfully resolved. Manages context on the Payroll intranet site. Provides payroll training for all new employees. Responsible for overseeing all the record keeping activities for the department which are maintained electronically. Administers information confidentiality principles by enforcing restricted access to the payroll area and files, directs staff to destroy confidential information according to the record retention policies, limits authorizations to the payroll and time attendance systems. Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies. Regularly disseminates this knowledge to the payroll staff. Oversees wage garnishment requirements by completing forms; adjusting payroll records, documenting and transmitting withholdings; negotiating with collection agencies to convert garnishments to wage assignments. Closely works will the Equity Team to manage a complex process to properly pay and tax LTI awards - Oversees and manages staff to accurately and timely process all payroll runs. Reviews and verifies the pay, payroll taxes, and deductions for each payroll. Manages and approves the payment processing for each payroll. Establishes project plans and calendars for the payroll activities and directs and monitor staff members of their actions during the payroll cycles. Ensures the data files transmitted by the various upstream systems (Workday, T Rowe Price, Business Solver, SAP ERP) are correctly processed. Responsible for processing the GL payroll and accrual interfaces for Accounting. Prepares and distributes reports. Initiates investigations and performs corrective adjustments as required. - Oversees and directs staff to configure, maintain and support the Payroll and Time and Attendance systems. Ensures the systems are appropriately configured and maintained. Manages the employee data management processes. Ensures the HR master data is transmitted to the Payroll and Time and Attendance systems is correctly processed and all other employee data elements are properly maintained. Support and maintain the PTO time interface to the RD Project Time system. Works closely with IT, HR, Equity, Accounting and Payroll professionals to implement new enhancements and modifications as required. Remain current on system developments within the industry and provide direction to company management for improvement where applicable. Develops and supports RPA automation processes for highly repetitive activities - Key payroll contact for the 401k and Executive Savings Plan administrator - T.Rowe Price. Ensure all file transfers are processed correctly and acts as the conduct point to address inaccuracies and performs corrective actions. Closely monitors deferred compensation, Executive savings, and 401k plans to ensure amounts are correct. Directs quarterly audits to confirm all the T Rowe Price system data reconciles with the payroll system. Responsible for providing key support for the annual 401K (5500) audit and ensure all deadlines are met. Regularly leads audit support activities for Federal and State audits as well as Internal and Tax audits. - Responsible to effectively coach, manage, and provide ongoing feedback to direct reports through formal and informal discussions. Activities include all necessary employee HR processes including objective setting sessions, Mid-Year Assessments, Year-End Assessments. Leads an employee development planning with each direct report. Sustains the payroll staff by recruiting, selecting, orienting, and training employees. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree required - Certified Payroll Professional (CPP); or the candidate possesses significant domain experience with the DSI payroll operations preferred - ADP Vantage Certifications preferred Experience Qualifications - 7 or More Years of progressive payroll experience required - ADP Payforce\Vantage and eTime expertise required - SAP and Workday Experience preferred Travel Ability to travel up to 5%. No travel requirements except for attending User Group Meetings or Payroll Conferences Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Associate Director, Payroll

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: <ul><li> The intern will be given a topic related to statistical programming, working on or assisting the development of programming tools (such as macros, utilities, or apps). </li><li> The intern will be assigned to a programming project using R/R Shiny to create tools for data visualization and summary tables. The primary goal is for the intern to receive training in statistical programming within a pharmaceutical company and to support basic programming activities under supervision. </li><li> The intern will in certain department activities and initiatives development. </li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: <ul><li> Enrolled in a BS or MS program in mathematics or statistics at an accredited college/university, with demonstrated knowledge of scientific programming. </li><li> Available for a full-time, 12-week commitment from June to August. </li><li> Detail-oriented, highly motivated, and able to manage multiple tasks while working both independently and collaboratively as a team member. </li><li> Proficient in at least one of the following programming languages: R/R Shiny, Python, or SAS. </li><li> Strong communication skills. </li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Biostatistics and Data Mgmt Programming - R Intern

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: <ul><li> The intern will be given a topic related to statistical programming, working on or assisting the development of programming tools (such as macros, utilities, or apps). </li><li> The intern will be assigned to a programming project using SAS to create tools for data visualization and summary tables. The primary goal is for the intern to receive training in statistical programming within a pharmaceutical company and to support basic programming activities under supervision. </li><li> The intern will in certain department activities and initiatives development. </li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: <ul><li> Enrolled in a BS or MS program in mathematics or statistics at an accredited college/university, with demonstrated knowledge of scientific programming. </li><li> Available for a full-time, 12-week commitment from June to August. </li><li> Detail-oriented, highly motivated, and able to manage multiple tasks while working both independently and collaboratively as a team member. </li><li> Proficient in at least one of the following programming languages: SAS, R/R Shiny, or Python. </li><li> Strong communication skills. </li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Biostatistics and Data Mgmt Programming - R / SAS Intern

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. We are currently seeking a Global Project Management and Leadership, Asset & Portfolio Management Intern for summer 2025. This full-time position works for approximately 37.5 hours per week. The qualified candidate will support initiatives for Daiichi Sankyo Global R&D function GPM&L in the Strategy, Innovation & Operational Excellence Group. Assignments will include basic understanding of project management skills, communications, and analytics. Responsibilities: <ul><li>Project Involvement: The intern will support projects related to Asset & Portfolio Management Learning and Development, Global Project Team effectiveness, and others as needed.</li><li>Task Assistance: The intern will help with day-to-day tasks such as taking meeting minutes and following up on action items.</li><li>Project Support: The intern will assist with key project deliverables and ongoing initiatives, ensuring these are completed efficiently.</li><li>Fresh Ideas: The intern will bring innovative ideas and help introduce new technology solutions to the team.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: <ul><li>Preferred experience in corporate environment</li><li>Project management experience is a plus</li><li>Ability to effectively manage multiple project deliverables simultaneously, and communicate when competing priorities arise</li><li>Attention to detail with a focus on data quality</li><li>Strong communication skills and comfort engaging with global workforce</li><li>Proficiency with project management and Microsoft tools, e.g., Project, Excel, PowerPoint, SharePoint</li><li>Takes pride in delivering high quality work and is accountable for the outcomes</li><li>Seeks ways to continuously improve their work and the work of their team</li><li>Punctuality, professionalism, and strong time management</li></ul> Qualified candidates must currently be enrolled in an accredited undergraduate program with a concentration in science, business or related field. Prior experience in a corporate business environment is preferred; experience in the pharmaceutical industry is a plus. Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Global Project Management and Leadership Intern

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Manager, Medical Content for the Medical Content and Training (MCT) team in Global Oncology Medical Affairs (GOMA) will support the development of high-quality global medical documents and ensure accuracy and scientific balance. As part of the medical review team, the manager is responsible for conducting comprehensive medical reviews and clearance of global materials. The Manager leverages his/her functional and technical expertise to assist in improving the organizational effectiveness of the MCT function. Responsibilities - Develop high-quality, scientifically sound Global Medical Information Documents, to fulfill unsolicited requests for information coming from Regional/Local Medical Affairs. Manage Medical Information Guidance Documents and Medical Q+As through the complete drafting, review, and approval process incorporating input/recommendations from other reviewers (e.g., Peer Reviewers, Legal Affairs reviewer, and Supervisor) and discussing with other functions as needed - Develop Medical Education content, including but not limited to external slide decks, summary cards, and other resources for use by Regional Medical Affairs - Conduct comprehensive medical review and clearance of materials/programs as a member of the global medical review team. Ensure comprehensive, high-quality, medical review and appropriate sign-off/approval of materials/programs in a timely fashionAttend review meetings, when applicableCollaborate closely with the GMA TA lead, the Publication lead, and/or other cross-functional stakeholders as needed to discuss content and scientific rigor of materials/programs and to assure alignment in Global /Regional Medical AffairsConsult with a supervisor as needed - Serve as an integral member of the Global Medical Affairs Team, to staff Medical Information booths at targeted medical conferences participate in projects/initiatives within GMA or across functions, as assigned. Support inquiry management, conduct inquiry analyses, develop global medical information reports and assist in providing customer insights Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Advanced scientific degree (e.g., Ph.D. or PharmD) required - Experience Qualifications - 1 or More Years experience in a medically related field including industry experience in Medical Affairs (experience in medical review and/or medical content is strongly preferred) required - Proven track record of working successfully with cross-functional teams to achieve results preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.