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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. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities:<ul><li>Study Strategy: Drafts development plan under guidance of CSL and/or Medical Monitor. Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates reference list for study.</li><li>Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; development of contingency plan; development of protocol profile, protocol, and ICF template; selection of ARO, CRO, and members for DSMB and/or adjudication committee; development of charters for study committees (e.g., Executive Committee). Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV'd) and to Biostatistics on Statistical Analysis Plan (SAP).</li><li>Study Execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.</li><li>External Collaboration: Consults with internal experts and external KOLs for protocol development; provides input on CRO and ARO Scope of Work and budget; participates in study team meetings with CRO and ARO; establishes effective communication with CRO, ARO, and vendors. Meets with commercial group regarding new indications for Life Cycle Management.</li><li>Additional non-study related activities: Clinical Development involvement in due diligence activities related to in-licensing and acquisitions. Performs literature review related to new indications for Life Cycle Management.</li></ul>Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>Master's Degree or equivalent preferred</li><li>PharmD or equivalent preferred</li><li>PhD or equivalent preferred</li><li>Postgraduate training in TA or related specialty, or equivalent preferred</li></ul>Experience:<ul><li>1 or More Years with PharmD, PhD and relevant clinical experience preferred</li><li>4 or More Years with master's degree and relevant clinical experience 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.

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Manager, Clinical Science

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: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product, and its approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities:<ul><li>Represents the assigned products to health care professionals in assigned sales territory.</li><li>Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers.</li><li>Develop and execute comprehensive business plans.</li><li>Applying knowledge of the healthcare industry, trends, applicable laws and regulations, market conditions, and the market access environment (including but not limited to pharmacy economics, payer reimbursement landscape, and patient flow/influence between academic institutions, hospitals, and community practices).</li><li>Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment.</li><li>Analyze customer needs and interests, territory performance, program outcomes, and business trends; develop and execute business plans that optimize the commercial potential of our products.</li><li>Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products.</li><li>Completes all assigned training.</li><li>Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts.</li><li>Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities.</li><li>Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings.</li><li>Meet all administrative expectations and standards, including budgets, reporting, and communication.</li><li>Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals.</li><li>Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals.</li><li>Submits completed reports on-time, and communicates matters that are relevant to the marketplace to the District Manager.</li><li>Maintains all equipment and territorial records in the prescribed manner.</li><li>Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management.</li><li>Adhere to compliance and operating principles and expectations.</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 of sales/marketing experience in the pharmaceutical or medical industry required</li><li>4 or More Years of oncology therapeutic experience strongly preferred</li><li>1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred</li><li>Oncology product launch experience preferred</li><li>Copromotion experience a plus</li><li>Strong verbal and written communications skills</li><li>Proficiency in MS Word, Excel, PowerPoint and Outlook</li><li>Must be able to travel approximately 40% to 60%</li><li>Must have a valid driver's license with a driving record that meets company</li><li>Compensation and seniority level/title based on experience and qualifications</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.

Oncology Territory Manager, Breast - Atlanta 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 Align and set strategic goals for Customer Insights & Market Analytics to ensure Daiichi Sankyo's future sales success across all partnered and in-line portfolio products. Directly shape how DSI will work and partner with sales leadership and global teams across, but not limited to, DSI, American Regent, Vifor, AZ, and Merck, develop key metrics to measure success for how teams work together to produce results for US OBD and improve upon our commercial position within the US. In addition, the individual will develop and oversee both the targeting, research and insights plans that compliantly motivate the field sales force, support brand objectives and help the company achieve its core business needs. This role identifies all go-to-market applications for all commercial customer facing entities. Determines if in-house or customer facing resources should be deployed, including level and investment. The Executive Director works with BD to evaluate and decide if commercialization assessments progress. This role is solely accountable for deal analyses and implementation of commercial partnerships. This role leads and certifies the call planning and targeting process to support the DSI portfolio and evaluates potential assets. The Executive Director, US Customer Insights & Market Analytics position will oversee both primary market research and secondary data analytics teams. Manage all day-to-day operations and represent the needs and interests of DSI with our partners to help ensure success for product sales. The Executive Director, US Customer Insights & Market Analytics will provide support to the VP, US Business Operations specific to sales force deployment. The position will also require the incumbent to be aware of environmental trends and act appropriately on behalf of DSI to drive ethical promotion of our products. Responsibilities - Execute on all brand and sales plans to achieve sales objectives for US OBD approved products and key milestones for pre-launch products. Ensure teams align field-facing resources to serve the needs of target customers in an ethical and compliant manner. - Leads and transforms the annual business planning cycles, to include: developing processes and controls for budgets, plans, and headcount efficiency. Provide ongoing strategic and tactical advice and counsel to Business Operations, Sales, Marketing, Market Access, and Medical Affairs. Oversee the development and execution of compliant call plans to ensure consistency with budget appropriations and support achievement of company goals. Assesses the implications to the 3-year plan and other internal planning cycles. - Oversee budget, manage team, and own operations for Market Analytics and Customer Insights. Adhere to and maximize budget for optimal business impact. Supervises, coaches, and leads development of direct and indirect reports to ensure high quality results. Responsible for the overall performance and development of all employees within scope, focusing on coaching, motivating and inspiring associates to accelerate performance. Partners with VP, US Business Operations and Human Resources Business Partner to hire, develop, train, and retain a highly productive and motivated team. Work directly with third party vendors to evaluate performance and ensure contracted service obligations are met. Ensure third party vendors operate with efficiencies and strategic excellence. - Solely responsible for the commercial evaluation of inline portfolio assessments. Determines and evaluates commercial feasibility including product assessments, market viability, commercial investment, go-or-no-go deals. Responsible for informing Head of US OBD and key cross-functional leaders. Accountable for meeting and exceeding all contract parameters defined, including the financial implementation. Informs DSI Corporate Finance and DSI BD and partners closely. - Leads the evaluation of all go-to-market assessments and resource deployment determinations to align deliverables and provide recommendations on 3-year planning horizon, informing decisions with enterprise-wide impact. 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 - MBA or Advanced degree/certificate preferred Experience Qualifications - 10 or More Years overall related experience required - 10 or More Years of progressive sales, marketing and or commercial experience preferred - 4 or More Years leadership experience required - Pharmaceutical Sales and/or Sales management experience preferred - Experience in Market Research/Customer Insights and Data Analytics required - Advanced analytical methods, a thorough understanding of anonymized patient-level claims data and AI/ML techniques required - Proven track record in developing strategic initiatives with cross-functional disciplines required Travel Ability to travel up to 30% 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.

Executive Director, Customer Insights and Market Analytics

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 100 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. 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 Accountable to manage and oversee QA GMP activities pertinent to commercial and Investigational Medicinal Products (IMP) to ensure the timely release and delivery of pharmaceutical products as per applicable regulatory standards and company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality, integrity and compliance with regulatory guidelines and internal/global standards and procedures. Responsible for managing activities within the Commercial and IMP Release Program which include management of product release programs, deviation investigation programs, standards development and training activities, and supporting complaint and recall programs. This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract Manufacturing Organization (CMO) leading a productive working relationship with internal/external stakeholders acting as partner to successfully drive commercial and IMP deliverables as appropriate. Responsibilities<ul><li>Drug Product Release: Manages the execution of assigned responsibilities within the commercial drug product and IMP release program to assure all external contractors provide GMP compliant product release documentation. Participates as a cross-functional team member to provide product quality/GMP support and assures proper documentation of drug product release programs in accordance with internal procedures. Support proactive planning and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.</li><li>Complaint and Recall Programs Establishment: Manages and participates in the commercial and IMP drug complaint investigation program and recall handling program and assures proper documentation of complaints and timely investigation and operation. Supports the receipt, logging, and assignment of complaint investigations for commercial and IMP drug products to ensure a timely investigation and that protective solutions identified to avoid significant quality or patient. Execute all recall operations activities and process directed by management when necessary.</li><li>Deviation Investigation Program: Manages and participates in the deviation investigations for commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved to ensure the quality standards required for DS products are met. Collaborates with internal and external stakeholders to complete deviations in a timely manner.</li><li>Development and Review of Standards and Procedures (SOPs) and Training Activities: Responsible for development and review of procedural documents that set compliance in QA GMP commercial and IMP processes and systems. Responsible to ensure the completeness and accurate timeline review and training for the relevant documents within QA Product Release Management Organization.</li><li>Cross-Functional Team Participation: Participates and supports development of cross-functional teams to provide product quality/GMP support for timely activities related with the release, planning and supply forecast of commercial and IMP drug product. Supports regulatory inspection and its readiness. Works diligently with CMO representatives and analytical labs in order to ensure the compliance for activities performed. Provides accurate and timely information for leadership to support the decision making process.</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 in scientific discipline required</li><li>Master's Degree or other advanced degree preferred</li></ul>Experience Qualifications<ul><li>4 or more years in pharmaceutical, biological and/or medical device operations including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit or equivalent experience</li><li>4 or more years experience with various pharmaceutical dosage forms</li><li>4 or More Years Solid understanding of quality management and continuous process improvement principles</li></ul>Travel<ul><li>Must have ability to travel up to 5% Travel (including overnight travel)</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, QA Product Release Management

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 Accountable to manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf of Daiichi Sankyo that provide services through the supply of commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is responsible to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with DS affiliates to support with routine and unusual issues related with Global Products. Responsibilities<ul><li>Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.</li><li>Drug Product Management: Supports technically the operational activities which include API and drug product manufacturing, packaging and labelling operations, QC testing and release, and distribution for biologics and small-molecules products manufactured at CMO's and ensures the validation requirements for all global markets are also met.</li><li>Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA RD functional areas, Regulatory Affairs - CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations.</li><li>Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and instructions that affects and directs CMO activities. This position can be supportive also to oversight and QA support for product and process technology for acquired or transferred product into and out of CMO's organizations.</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>Must have a Bachelor's Degree Bachelor's Degree in scientific discipline required</li><li>Master's Degree or other advanced degree preferred</li></ul>Experience Qualifications<ul><li>Must have 4 or more years of proven biological or pharmaceutical operations experience including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit.</li><li>Demonstrated experience dealing with contract manufacturing organizations</li><li>Must have solid understanding of quality management and continuous process improvement principles including global cGMP requirements.</li><li>Experience with biologics manufacturing and technical transfer strongly preferred</li><li>Direct experience dealing with multinational drug regulators.</li><li>Experience with Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is desirable.</li><li>Management experience is preferred.</li></ul>Travel <ul><li>Must have ability to travel up to 30% of the time either domestic or international</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, External Supplier QA-GMP

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 Accountable to lead, manage and ensure that all Contract Manufacturing, Testing and Warehousing organizations contracted by or on behalf of Daiichi Sankyo that provide services through the supply of commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS policies, procedures or standards. The incumbent is responsible to identify QA risks at CMO's and support the recommended courses of risk treatment and resolution manner in appropriate way and to ensure continuous improvement in the management of CMO risks. Interacts with DS affiliates and Headquarter to support with routine and unusual issues related with Global Products. Responsibilities<ul><li>Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.</li><li>Drug Product Management: Supports technically the operational activities which include API and drug product manufacturing, packaging and labelling operations, QC testing and release, and distribution for biologics and small-molecules products manufactured at CMO's and ensures the validation requirements for all global markets are also met.</li><li>Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA RD functional areas, Regulatory Affairs - CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations.</li><li>Process Validation and Product Technical Transfer: Responsible for review and approval of documents associated with validation or qualification activities, risk assessment strategies, technical studies and applicable changes that may require DS support. Ensure respective compliance with applicable DSI and or DS relevant procedures, standards and instructions that affects and directs CMO activities. This position can be supportive also to oversight and QA support for product and process technology for acquired or transferred product into and out of CMO's organizations.</li><li>Deviation and Complaint Investigation Program: Provides support to the investigation of deviations and complaints in order to ensure a timely manner activity and a protective solution to avoid any risk to the quality and safety of commercial and investigational drug products supplied through DSI and DS affiliates.</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>Must have a Bachelor's in scientific discipline required or</li><li>Master's Degree or other advanced degree preferred</li></ul>Experience Qualifications<ul><li>7 or more years in biological or pharmaceutical operations including required along with first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit.</li><li>Experience with biological manufacturing and technical transfer required along with experience dealing with contract manufacturing organizations.</li><li>Must have proven experience dealing with multinational drug regulators.</li><li>Demonstrated understanding of quality management and continuous process improvement principles including global cGMP requirements.</li><li>Expertise in Aseptic/Sterile Manufacturing and/or experience in a project environment within the pharmaceutical or biopharmaceutical industries and/or cold chain qualifications is strong preferred.</li><li>Previous management experience preferred</li></ul>Travel Must have the ability to travel up to 30% domestic and international 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, External Supplier QA-GMP

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, 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>Experience in the pharmaceutical industry</li><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 required</li><li>Applied knowledge of FDA labeling requirements 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.

Manager, Global Labeling

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 Position is responsible for advanced support at the global/complex organizational level, directly reports to a functional executive. This position performs support tasks with an applied knowledge of the complexity of the organization. This position commonly handles ambiguous work with no direct guidance. This position makes independent decisions using past experience and independently solves problems encountered while carrying out work. Additionally, this position is responsible for upholding a strong commitment to confidentiality and frequently handles sensitive documents that may impact multiple organizational units. This position has expert skills in and can train others in technology systems, which includes word processing, data management, and business emailing software as well as database and research tools. This position may also be responsible for using analysis to assess budget and inventory status. Responsibilities<ul><li>Serves as the go-to person for the function, and as a role model/lead for the Administrative Support organizational unit</li><li>Creates and proofs packets of information; develops documents and materials for meetings and a wide array of audiences</li><li>Edits and produces advanced internal and external communications; acts on behalf of an executive for certain decisions or activities (e.g., e-mails)</li><li>Independently manages calendars, including complex meeting and travel coordination as well as schedules and confirms internal and external appointments for individuals; prioritizes competing demands and requests</li><li>Interfaces with vendors re: invoicing, reconciliation, and performs advanced level of stakeholder management; majority of contact is within and across organizational units and across a global/complex organizational matrix</li><li>Initiates and manages projects (includes budgets) or process improvements with minimal supervision, for example, creates and manages contracts for function and/or process</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>High School Diploma or equivalent required</li><li>Associate's Degree or equivalent work experience preferred</li></ul>Experience Qualifications<ul><li>7 or More Years prior experience required</li></ul>Physical Requirements Miscellaneous. May still need to move/organize/ship large quantities of items or supplies for meetings, etc. Especially may apply to an admin in a Field Sales office. 5% of Time 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.

Executive Administrative Assistant

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 100 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. 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<ul><li>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.</li><li>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.</li><li>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.</li><li>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.</li><li>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.</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) 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 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 is responsible for administrative tasks (e.g., mailbox management). This level interacts with internal and interdepartmental teams the majority of the time with occasional communication with external vendors and the global CSPV team. This position assists in the monthly maintenance and reconciliation. This position is expected to handle ICSR issues in accordance with SOPs, SOIs, and experience and escalate more complex problems to management. Responsibilities: <ul><li> Case Receipt/Book-In/ Case Processing: This includes monitoring of e- mail boxes for new cases, performing duplicate checks, entering PQC information/follow up outreach attempts and attaching electronic source documents, as well as creating/retrieving case file folders.</li><li> Reconciliation: Performs monthly maintenance and reconciliation of trackers for safety data exchanged with license partners and CROs. Participates in clinical SAE reconciliation</li><li> Querying/Reporting: Performs standard database searches/output in support of clinical-safety database reconciliation, as well for routine recurring monthly requests safety data.</li><li> Case Processing Policies and Procedures: Participates in development of process guides which are used to ensure consistency and compliance in case processing and adherence to regulatory guidelines.</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 in nursing, pharmacy, or healthcare related field preferred</li></ul> Experience Qualifications: <ul><li>1 or more years of relevant healthcare experience required</li><li>1 or more years PV experience required</li><li>Knowledge of FDA regulations. preferred</li></ul> Competencies: <ul><li>Delivers high quality work, assesses individual and vendor/CRO work with minimal supervision</li><li>Executes strategic plans within multiple projects and can prioritize in accordance with strategy.</li><li>Competent in identifying and understanding issues independently and can contribute to remediation plans</li><li>Competent knowledge of pharmacology, clinical research and medical terminology, global data entry conventions and systems and procedures for application in daily work.</li><li>Communicates effectively with team/project members using clear and effective verbal and written communication skills</li><li>Effectively manages own workload to meet multiple deadlines in a timely manner.</li><li>Understands functional role and others' functional roles within the clinical trial process</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, Case Processing CSPV

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 100 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. 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 serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the broader RA team. This position manages assigned developmental and post marketing projects with a high level of supervision. This position prepares content templates and supports the technical team in the preparation of submission documents (e.g., IND, IB, NDA, Amendments, Supplements, Briefing Books) for review by higher-level manager. This position demonstrates understanding of key regulatory guidances and their application during the development process. Additionally, this position interacts with the Contract Sales Organization (CSO). This position works with problems that are typically simple, straightforward and task driven. This position has a high level of supervision and is supportive in nature. Responsibilities:<ul><li> Planning for Development and Post Marketing Projects: Manages CMC development and post marketing projects.</li><li> Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for review by higher-level manager.</li><li> FDA Interactions: Leads FDA interactions with high level of supervision.</li><li> Regulatory Knowledge: Demonstrates understanding of key US regulatory guidance's and their application during the development process.</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 in a scientific discipline required</li><li>Master's Degree in a scientific discipline preferred</li></ul> Experience Qualifications <ul><li>5 - 8 years of pharmaceutical industry experience with 2+ years of direct or related CMC regulatory experience preferred</li><li>Ability to travel up to 5%</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, RACMC

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 Oncology Medical Affairs (GOMA) Director, Program Management & Operational Excellence provides strategic planning and operational management oversight of GOMA projects, activities, and budgets. The Director, Program Management & Operational Excellence is responsible for supporting the Head, Program Management & Operational Excellence, the assigned Global Medical Affairs Team (GMAT) or Functional Lead, and the Franchise or Function Head to deliver GOMA projects and activities successfully and in a timely manner while working in a fast-moving, matrixed organization. The Director, Program Management & Operational Excellence is responsible acting as the "Chief of Staff" for his/her team, leading efforts to achieve overall operational excellence across all activities and projects to accelerate business in a compliant and efficient manner. The Director, Program Management & Operational Excellence further contributes to accelerating and optimizing the business via the following responsibilities / activities: &bull; Leading / contributing to process improvement initiatives &bull; Ensuring streamlined and efficient communication &bull; Escalating issues in a timely manner &bull; Budget management and oversight of contract-to-purchase order (PO) process &bull; Facilitating key meetings (internal GMA, cross-functional, cross-regional, vendor meetings, etc.) &bull; Tracking of activities in terms of timing, anticipated risk, and mitigation of issues/conflict resolutions &bull; Encouraging overall operational excellence across all activities and projects Responsibilities<ul><li>GMAT/Function Support In close collaboration with the Team Lead (GMAT or Function), establish a strategic plan for monitoring the activities per the Business Plan and priorities. Support Team Lead to manage GOMA project/activities, including ensuring that the GMAT/Function team delivers projects/activities successfully and on a timely manner as per annual plan & objectives. Establish milestones and metrics, in collaboration with GMAT/Function team, and develop a detailed project plan in order to track progress and measure impact of the activity. Generates critical path analyses and supports scenario planning for each GMAT/Function, in order to assess if objectives are met, exceeded, or not met. Have a strong understanding of activities, associated budget, and key contributing factors in order to anticipate potential risks and establish plan to mitigate, as appropriate. Lead and facilitate regular internal GOMA & cross-functional/cross-regional team meetings; ensure agendas and team priorities are clear, meetings minutes are distributed, action items are completed. Lead the budget planning and tracking process for GMAT/Function team; work with GMAT/Function Leads to provide consolidated budget/LE updates (across all activities and regions) in a timely manner with appropriate rationale. Support GMAT/Function lead with annual Business Planning process & associated documents, including proactive engagement with internal and external stakeholders to manage plan development. Proactively follow-up on action items and requests of GMAT/Franchise Lead. Support GMAT/Function/Franchise Head in prioritization and planning of resources and develop rationale for annual resource planning. Lead issue resolution meetings. Lead risk identification, prioritization, and mitigation planning processes across the Franchise. Manage the agendas for GMAT/Function meetings, the conduct of the GMAT/Function meetings, and the drafting of GMAT/Function meeting minutes. Ensure full documentation of meeting discussions, decisions and action items. Track & ensure completion of agreed action items. Ensure appropriate archiving of project documentation. Develop a monthly report that provides an overview of progress on all key activities, potential risks and mitigation actions. Generate and maintain strategic integrated GOMA Franchise project plans, project timelines, high quality risk management plans, and communication plans, as needed.</li><li>Operational Excellence Support Collaborate with Head, Program Management & Operational Excellence to further strengthen operational excellence from a GOMA-wide organization perspective. Disseminate key leadership communications throughout GMAT/Functional teams and lead issue escalation efforts when required. Identify gaps in Global Oncology Medical Affairs processes and functional procedures that (potentially) impact program delivery and escalate appropriately to Head, Program Management & Operational Excellence. Collaborate with Head, Program Management & Operational Excellence and GMAT/Functional Leads for formal presentations/communications to GOMA Head and Senior management. Support Head, Program Management & Operational Excellence with monthly and annual updates to Senior leadership. Integrate operational excellence best practices into regular team meetings and communications to enhance overall capabilities.</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 with relevant professional experience or equivalent required</li><li>advanced degree preferred</li></ul>Experience Qualifications<ul><li>7 or More Years experience in project management with at least five years in pharmaceutical industry required</li><li>Medical Affairs experience strongly preferred</li><li>Demonstrated leadership skills, especially in the areas of communication and change management required</li><li>Meticulous attention to detail in all aspects of work and expert organization skills required</li><li>Proven ability to drive decision making process, including ability to challenge teams and achieve excellence required</li><li>Ability to thrive in a fast-paced environment required</li><li>Self-starter, results-oriented required</li><li>Strong change management skills and engagement to enable continuous improvement required</li><li>Strong communication skills and ability to adapt according to different levels of management required</li><li>Ability to negotiate and align across teams required</li><li>Demonstrated ability to collaborate effectively with key stakeholders required</li><li>Strong Microsoft Office skills required 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.

Director, Global Oncology Medical Affairs - Program Management

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 purpose of this job is to support BDM infrastructure committees, vendor oversight, provide project management activities, interface with technical study teams and other departments on BDM and cross R&D or cross Business Unit initiatives. Responsibilities: - Serve as Project Manager for BDM initiatives and BDM Functional Excellence. Create and maintain tracking logs for Infrastructure Committees, drive expected follow-up activities per the action log, and become the point person for status updates - Coordinate and chair meetings for BDM or cross departmental non-project related initiatives and/or brainstorming sessions - Develop BDM or cross-RD/Business Unit information bulletins or training to support continuous reinforcement of decisions from the BDM Governance committees - Remain current with HA Regulation/Guidelines, ICH, and Literature to provide broad basis of information to support/challenge proposals submitted to the BDM Governance committees. Summarize and disseminate impact of guidance changes to BDM across all functions. 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); - Master's Degree in life sciences or related field preferred - Bachelor's Degree in life sciences or related field preferred Experience Qualifications - 7 or More Years Training in Lean/six sigma, brainstorming, or Quality Engineering preferred - 7 or More Years with Bachelor's degree (or Master's degree with minimum of 5 years) experience within pharmaceutical industry or CROs. 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.

Associate Director, BDM Planning and Functional 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 Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy or specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework. This individual will use strong leadership and communication skills to ensure effective collaboration across development functions and sites. The individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Specific responsibilities will vary depending on the stage of development of assigned projects (i.e., Phase I through commercialization). Responsibilities<ul><li>Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and scientists responsible for a compound/product safety, including project-specific training and coaching of team members and review of team output cross-functionally.</li><li>Effectively represent the CSPV on the Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety leadership and serving as the primary point of contact.</li><li>Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and relatedness.</li><li>Lead internal and external (especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.</li><li>Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle.</li><li>Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time.</li><li>Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments).</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>MD Board certification or eligibility required</li></ul>Experience Qualifications<ul><li>4 or more years of professional experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology required.</li><li>Must have expertise in global clinical safety</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.

Director, Clinical Safety MD

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 Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis of team's proposals in partnership with a Global Team leader for high complexity projects/programs. Works effectively across organizational lines to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position is also responsible for developing PM talent and may also manage a team of PMs. This position may be assigned to provide leadership to a therapeutic area (TA) or significant business collaboration and ensure effective PM resourcing to projects within the portfolio. As a member of the GMP&L leadership team this position is also responsible for developing and executing departmental objectives as well as supporting the global R&D organization in identifying organizational process gaps, developing and implementing solutions to help improve or optimize organizational efficiency and decision making. Responsibilities: Project Responsibilities<ul><li>Independently manage or lead strategy development for high complexity drug development projects/programs. Manages the Global Project Team(s) in partnership with the Global Team Leader to drive strategy development and create an integrated product development plan and timelines. Ensure execution of overall plan and annual goals.</li><li>Responsible for developing and maintaining a high performing team.</li><li>Generate critical path analyses and lead scenario planning with GPT to select best option understanding cost and timeline implications.</li><li>Resolve complex problems and identify gaps in the project or organization.</li><li>Mobilize others to gain alignment with the most Sr leaders and secure resources for the project.</li><li>Accountable for the accuracy of project status in the project management information systems, for preparing scope change proposals and stage gate proposals for formal presentation to senior management. Can step in, as needed, on behalf of the Global Team Leader to deliver presentations to Sr Management.</li></ul>Departmental Responsibilities:<ul><li>Work independently within a matrix environment and coach, influence and mentor more junior PMs, Team members and project stakeholders.</li><li>As a TA lead or Lead on a Business Collaboration, will contribute to portfolio management by participating in global TA strategy committees and have an in depth understanding of project strategies/plans.</li><li>As a staff manager, responsible for coaching PMs on project-related issues including review of their Monthly Project Summary Reports and governance presentations. Responsible for talent development and ensuring that staff have actionable development plans and receive ongoing coaching and feedback.</li><li>Provide leadership to the Global PM function by supporting budget and resource management, annual goals setting as well as strategic direction for the department. Identify and implement PM best practices for the broader GPM organization. Ensure organizational awareness of the Global Development 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 Bachelor's degree in a scientific discipline with additional relevant experience is required</li><li>Advanced degree (i.e., MS, MBA or PhD) in a scientific discipline with additional relevant experience preferred</li></ul>Experience Qualifications:<ul><li>10 or More Years in a drug development PM role or related role In Biotech or Pharmaceutical industry</li><li>10 or More Years Demonstrated success as a project manager/leader in planning and executing strategies for global drug development: early stage, late stage and life cycle management preferred</li><li>10 or More Years Proven track record as a leader/influencer in a global role. preferred</li><li>10 or More Years Direct people management experience with ability to identify and recruit talent. preferred</li></ul>Licenses and Certifications:<ul><li>Certified Project Management Professional (PMP)-PMI and/or training in project management preferred</li></ul>Travel: Ability to travel up to 5% 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.

Senior Director, Global Project Management & Leadership (Drug Development)

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 will assist in supporting several areas within Legal Operations, including but not limited to; Contract Management, Program and Grants process, website administration and other assigned areas. Responsibilities<ul><li>Independent management, organization and administration of the PGC process by conducting intake and organizing all PGC requests in Electronic Document Management System (EDMS). Conduct independent initial review of all incoming requests to determine if they comply with policy and procedure requirements and warrant PGC review; make decisions regarding actions to be taken on each request, communicate with counsel and compliance on a regular basis. Communicate daily with colleagues of PGC to assist with other submissions where necessary. Utilize independent judgment and make decisions in responding to questions related to assigned matters, processes and procedures.</li><li>Oversee and provide day-to-day operation of the contract management process for the Commercial and Development Divisions. Act as a contact person for the process, intake contract requests, prepare contracts, work directly with internal clients (varying levels) and external vendors. Work with company attorneys to review legal language for company agreements. As necessary, negotiate with opposing party with support from manager or attorneys to resolve contract language disputes. Communicate daily with colleagues within Contract Management to assist with other submissions where necessary.</li><li>Manage, administer and maintain the Legal Affairs Intranet page. This includes developing new forms, posting procedures, working with IT in posting and linking updated policies and AOPs, making any changes requested by colleagues within Legal Affairs.</li><li>Other projects as assigned within, or by, the Legal Operations or Legal Affairs groups</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>High School Diploma or equivalent required</li><li>Associate's Degree or Business School degree preferred</li></ul>Experience Qualifications<ul><li>1 or More Years pharmaceutical experience plus experience in contracting preferred</li><li>Familiarity with laws and/or industry guidance governing interactions with healthcare professionals and/or knowledge of pharmaceutical marketing and contracting 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, Legal Operations

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: This position is responsible for implementation and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements to achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and reporting under RBQM Central Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during RBQM Risk Assessment. Responsibilities: CSM Execution: <ul><li>Provides tactical approaches and leads implementation of vision for risk-based quality management within impacted Daiichi Sankyo functions globally and with external parties as required.</li><li>Champions 'Quality by Design' and Quality Risk Management approaches to quality management within Daiichi Sankyo RD and works to develop a culture that supports these approaches.</li><li>Create and implement processes for Daiichi Sankyo RBQM future state including operating model, SOPs, study resource requirements, and supportive technology (as needed), for the risk-based central monitoring function.</li><li>Interacts with and influences internal management and study level stakeholders on risk-based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.</li><li>Aligns with the RBQM Risk Management Lead on critical-to-quality factors and study-level critical variables and processes, as a precursor to the risk-based central monitoring during study conduct.</li><li>Monitors external environment and incorporates RBQM industry benchmarking, best practices, and emerging solutions within Daiichi Sankyo.</li><li>Ensures DS and any RBQM vendors meets risk-based quality management expectations as defined by ICH, FDA, EMA, PMDA and other Health Authorities.</li><li>Oversee Development and Implementation of RBQM Standards, Tools and Training</li><li>Ensure Daiichi Sankyo RBQM study level practices for RD studies comply with industry regulations / updates (e.g. new requirements), including conduct of impact assessments and implementation of changes as required.</li><li>Lead development and maintenance of RBQM standards such as guiding principles, risk, quality tolerance limit (QTL) libraries, and critical-to-quality factors.</li><li>Lead RBQM Center of Excellence for central statistical monitoring topics, ensure optimal utilization of the cross functional SMEs to embed RBQM across portfolio of studies and ensure adoption.</li><li>Engage with selection of RBQM vendors or RBQM platforms and tools</li><li>Develop and implement tools to maximize the consistency, effectiveness, and efficiency of the RBQM processes across Daiichi Sankyo compounds with a focus on oversight, lessons learned and inspection readiness.</li><li>Lead assessment of training needs and ensure delivery of RBQM CSM Training with Learning and Development team members.</li><li>Lead development and implementation of process improvement initiatives related to RBQM CSM to improve quality and ensure patient safety and data quality and integrity.</li><li>Establish, measure, analyze and report on RBQM CSM related metrics and present outputs to Leadership and Management to drive RBQM Implementation.</li><li>Oversee RBQM central statistical monitoring activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee and mentor junior staff to ensure proper implementation and execution of RBQM and inspection readiness.</li><li>Review and determine acceptability of CRO / vendor RBQM practices and associated tools with outsourcing, following Daiichi Sankyo standards. Support internalization of RBQM and Central Statistical Monitoring activities including internal production of QTLs and visualization/tabulations to detect data oddities, trends, or when site(s) are potentially under/over reporting clinical outcomes (eg, earlier/later than expected progressive disease, more/less protocol deviations, more/less SAE) compared to other study sites.</li><li>Introduce and implement methods to detect fraud or site non-compliance such as: different approaches to data review in conjunction with Data Management and Clinical Science, audit trail review for non-logical timing of entry and/or source data collection, use of statistical control charts to identify trends, or use of statistical methods to identify site differentials.</li><li>Participate in CRO / vendor governance, ensure oversight of provider RBQM processes and tools and work collaboratively with partners to develop RBQM approaches. Ensure that methods and definitions used by providers are aligned with those used by internal DS functions.</li><li>Act as issue escalation point for study teams related to RBQM and ensure timely and thorough problem resolution as required.</li></ul>People Management Leadership:<ul><li>Accountable for the management, development, recruitment and training of employees within the departmental scope to meet current and future business needs.</li><li>Provides exceptional leadership to employees within responsible areas. Leads coaching and development of employees across the function.</li><li>Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.</li><li>Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance.</li><li>Responsible to create an environment where employees feel engaged and empowered, and take pride in their roles, responsibilities, and deliverables.</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 biology, pharmacy, nursing, or other scientific discipline, or statistics, data science or related discipline. required</li><li>Master's Degree preferred</li></ul>Experience:<ul><li>10 or More Years of related pharmaceutical industry or Clinical Research Organization experience required</li><li>4 or More Years monitoring experience and advanced knowledge of risk-based quality management (e.g. Quality by Design principles; Quality Risk Identification and Management processes; root cause analysis; process mapping; etc.) preferred</li></ul>Travel:<ul><li>Ability to 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.

Director, RBQM Central Statistical Monitoring (CSM)

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 is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position. Responsibilities:<ul><li>Develops and updates Study Supply Plans in close communication with CSO project Management Lead.</li><li>Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.</li><li>Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.</li><li>Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.</li><li>Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.</li><li>Vendor Management -supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to ship.</li><li>Assists in the creation of SOP's and work instructions specific to CSO Supply Planning as requested.</li><li>Responsible for updating relevant Trial Master Files (TMF) with CSO-related documents.</li><li>Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management.</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>PharmD or related field preferred</li><li>Master's Degree preferred</li></ul> Experience Qualifications: <ul><li>7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferred</li><li>Oncology experience preferred</li><li>Creation of Supply Planning tools preferred</li><li>Ability to travel up to 10% Overnight / single-day travel will be required to go to outsourcing vendors from time to time infrequently.</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, Clinical Supply Lead - Program Management

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. Responsibilities<ul><li>Strategic Leadership Develop and execute a robust Continuous Improvement and Operational Excellence strategy aligned with organizational objectives. Champion a DX-DSS-wide culture of continuous improvement by aligning teams to embrace Lean, Six Sigma, and related methodologies. Partner with senior leadership to identify and prioritize improvement opportunities with the greatest impact.</li><li>Process Optimization Lead initiatives to standardize, simplify, and optimize core processes across departments. Utilize Lean, Six Sigma, and other improvement methodologies to eliminate inefficiencies and reduce costs. Establish and monitor performance metrics (KPIs) to evaluate the success of improvement initiatives.</li><li>Continuous Improvement Implement and sustain a Continuous Improvement framework to enable ongoing assessment and enhancement of operational processes. Facilitate workshops, kaizen events, and cross-functional collaboration to drive engagement in continuous improvement efforts. Develop and implement tools and training to empower employees to identify and act on improvement opportunities.</li><li>Change Management and Cultural Transformation Act as a change agent to drive the adoption of continuous improvement and operational excellence principles. Build strong relationships across departments to ensure alignment and commitment to improvement initiatives. Communicate clearly and effectively with stakeholders at all levels to articulate the value and progress of continuous improvement efforts.</li><li>Team Leadership Lead, mentor, and develop a team of Continuous Improvement professionals to drive excellence in project execution. Foster an environment of collaboration, innovation, and accountability. Build organizational capability by delivering training programs that enhance Lean and Six Sigma skills across the workforce.</li><li>Innovation and Best Practices Stay current on industry best practices, emerging trends, and innovations in continuous improvement. Leverage technology and data analytics to enhance decision-making and streamline operations. Ensure compliance with regulatory requirements and industry standards in all improvement 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 B.S. degree with relevant professional experience or equivalent, advanced degree (PhD, MBA) desirable required</li></ul> Experience Qualifications <ul><li>10 or More Years Minimum 10 years experience including at least 3 years within Pharma required</li><li>7 or More Years Lean, Six Sigma, or Agile certification preferred preferred</li><li>Proven track record of deploying a range of tools/methods to improve operational performance</li><li>Comfort working in a global matrixed organization</li><li>Ability to travel up to 10% Up to 15% domestic and international travel</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.

Director, Global Operational Excellence, DX, DSS

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 Associate Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process, define strategies to lead to the development and implementation of quality improvement initiatives across the organization.</li><li>This role will focus on driving operational efficiency, ensuring compliance with industry standards, and fostering a culture of continuous improvement.</li><li>This position has a strategic responsibility to drive the maturity of GMP organization working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business functions and affiliates to ensure the deployment of operational strategies, global projects and initiatives, focusing on enhancing processes efficiency, culture permeation and team capabilities.</li><li>The incumbent will bring a combination of technical expertise, influential skills, and a passion for process optimization to deliver measurable results through the engagement in design and develop methodologies, pursuing the implementation of projects and monitoring the implemented measures deploying appropriate metrics and assessing initiatives periodically to ensure the reduction of risks associated and accelerating the penetration of an excellence and quality culture across the organization.</li></ul>RESPONSIBILITIES Process Excellence: <ul><li>Accountable to develop and execute strategies to enhance quality processes and systems organization-wide. Identify and implement best practices for process improvement and standardization. Lead cross-functional teams in the analysis and redesign of business processes. Ensure compliance with regulatory standards (e.g., ICH, FDA, or other industry-specific requirements). Conduct regular assessments to evaluate process performance and adherence.</li></ul>Change Management<ul><li>Act as change agent to promote a culture of continuous improvement and quality awareness. Design, deliver and implement training programs worldwide to enhance employee engagement in quality initiatives. Collaborate with a diverse group of stakeholders to ensure alignment of process improvements with organizational goals.</li></ul>Data Analysis and Reporting<ul><li>Utilize data-driven approaches to identify process inefficiencies and areas for improvement. Develop and perform assessments when necessary to evaluate the data collected and provide meaningful insights to the deployment of future strategies. Establish key performance indicators (KPIs) and track progress toward quality objectives. Prepare and present reports to senior leadership on quality performance and improvement outcomes. Develop tools, deliverable formats and methodologies for process improvement, management of compliance requirements and effectiveness check review to ensure the local and global adherence to the processes defined.</li></ul>Team Development<ul><li>Mentor and guide team members in quality methodologies, such as Six Sigma, Lean, and Kaizen. Foster a collaborative environment to encourage innovation and problem-solving. Support the development of global initiative trainings to ensure the increase of skills rolling out the model to support the growth of the organization and the accommodation to the business strategies aligned with mid- and long-term plans.</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>A Bachelor's degree in a scientific discipline is required</li><li>A Master's Degree preferred</li></ul>Experience Qualifications<ul><li>Must have 7+ years of professional industry experience in pharmaceutical operation including first-hand knowledge of drug manufacturing, packaging, QA, compliance, and audit</li><li>Must have a proven track record of implementing large-scale process improvement initiatives, including cultural initiatives</li><li>Direct experience dealing with multinational drug regulators, previous management experience and experience with various pharmaceutical dosage forms highly preferred</li></ul>Travel Ability <ul><li>Up to 10% both domestic and international</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.