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Daiichi Sankyo Inc.
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  • At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory Manager represents the assigned product(s), and their approved indications, providing approved disease state and product information, and resources to physicians and other customer stakeholders. Responsibilities Achieves or exceeds sales objectives through promotion of product features and benefits to our key accounts: Academic Institutions, Hospitals, Infusion Centers, Hematologists, Hospitalist, Bone Marrow Transplant members, buying groups, distributors and wholesalers in assigned territory. Builds relationships with our customer base and key opinion leaders by personally visiting them, educating and influencing physicians and healthcare providers to prescribe Daiichi Sankyo, Inc.'s promoted products. Communicates in a fair and balanced way, products' approved indications, advantages, features and benefits in both individual and group settings. Analyzes customer needs and interests. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Carries out all sales and marketing programs. Maintains frequent correspondence with District Manager, co-promotion team members, CARE team members and counterparts across the district and region. Complies with applicable laws in providing healthcare providers with accurate information concerning Daiichi Sankyo, Inc.'s products. Participates in assigned training and completing outside reading. Keeps abreast of the products, applications, technical service, market conditions, competitive activities, advertising, and promotional trends through the reading of pertinent literature and consulting with colleagues. Attends and participates in all required meetings and training programs. Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits complete reports, on-time, and communicates matters that are relevant to the marketplace, competition and the marketing team to the District Manager. Notifies the Medical Affairs Pharmacovigilance immediately of any product complaints as per SOP 805.21, Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).' 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 Experience Qualifications: 4 or More Years overall pharma or healthcare related experience required 1 or More Years sales/marketing experience in the pharmaceutical or medical industry required specialty, rare disease, and/or oncology experience strongly preferred experience selling in complex environments preferred Additional Qualifications: Must be able to travel up to 60% Must have a valid driver's license with a driving record that meets company requirements Compensation and seniority level/title based on experience and qualifications 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. Salary Range: USD$139,440.00 - USD$209,160.00 Download Our Benefits Summary PDF Read Less
  • Director, Early Phase Biostatistics  

    - Basking Ridge
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Position leads multiple early phase compounds or complex studies contributing to clinical development plan, and responsible for statistical design, analysis and interpretation of results independently with minimal supervision. This position provides strategic inputs to entire drug development plans with minimal supervision and regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. This position utilizes innovative trial designs and modeling to optimize the statistical handling in the projects, in collaboration with statistical innovation group, precision medicine biostat group, and real-world data (RWD) group. This position collaborates with cross functional project leaders from translational medicine, clinical operation, CSPV, clinical development and other functions in GPTs Job Description Responsibilities Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted. Leads the implementation of statistical methodologies and addresses specific statistical issues in the design and modeling of responsible clinical studies. Act as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product. May also serve as a lead statistician for certain studies and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted. Ensures consistency in -derived data definition, - statistical analysis and result interpretation; Leads the planning and analysis of integrated efficacy and safety data. Mentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). CRO / Vendor Interaction: Participates in reviewing the proposal for CRO selection. Reviews and negotiates - timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, - analysis methodologies, and interpretation of analysis results. Ensures timely delivery of high quality deliverables. Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed. Initiatives and harmonization to improve drug development: Lead or contribute to initiatives to optimize the process and save cost in drug development. Qualifications Education PhD in statistics or biostatistics required Work Experience 7+ years of relevant experience in the pharmaceutical industry required Competencies Expert knowledge of drug development and statistical methodologies. Excellent programming skills in SAS and/or R. Excellent oral and written communication skills. Working knowledge of statistical software package such as NQUERY, EAST, etc. Excellent Project planning skills. Demonstrated expertise in trial design and data analysis. Excellent collaborating skills. Travel Requirements Ability to travel up to 20% International travel may be 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. Salary Range: USD$201,840.00 - USD$302,760.00 Download Our Benefits Summary PDF Read Less
  • Oncology Territory Manager, Breast - Phoenix S  

    - Phoenix
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job 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 Represents the assigned products to health care professionals in assigned sales territory. Achieves or exceeds sales objectives through promotion of the assigned product features and benefits to assigned customers. Develop and execute comprehensive business plans. 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). Demonstrate understanding of current or pending clinical pathways in assigned accounts, and how they influence patient treatment. 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. Maintain expert understanding of the relevant disease state(s), assigned Daiichi Sankyo brands, and competitor products. Completes all assigned training. Serves as a disease state expert and provides a high level of product expertise and customer service for all accounts. Communicates on a regular basis with District Manager, internal and co-promote peers and discuss issues and opportunities. Builds relationships with Daiichi Sankyo customer base and key opinion leaders. Communicates products approved indications, features and benefits in both individual and group settings. Meet all administrative expectations and standards, including budgets, reporting, and communication. Maintains a current key customer target list, submits regular updates to the customer database and plans calls to meet goals. Reviews territorial reports with District Manager and learns how to use reports and databases as instruments to achieve assigned goals. Submits completed reports on-time and communicates matters that are relevant to the marketplace to the District Manager. Maintains all equipment and territorial records in the prescribed manner. Utilizes sales force automation system and other equipment to enhance impact of sales call and territory management. Adhere to compliance and operating principles and expectations. 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 Experience Qualifications: 4 or More Years of sales/marketing experience in the pharmaceutical or medical industry required 4 or More Years of oncology therapeutic experience strongly preferred 1 or More Years additional therapeutic experience in diverse roles - training, marketing, market access preferred Oncology product launch experience preferred Copromotion experience a plus Strong verbal and written communications skills Proficiency in MS Word, Excel, PowerPoint and Outlook Additional Qualifications: Must be able to travel approximately 40% to 60% Must have a valid driver's license with a driving record that meets company Compensation and seniority level/title based on experience and qualifications 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. Salary Range: USD$146,400 - USD$219,600 Download Our Benefits Summary PDF Read Less
  • Senior Analyst, Disbursements  

    - Basking Ridge
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary This position is part of a team responsible for providing a quality end-to-end experience of the disbursements processes. This position is responsible for the accurate and timely processing of accounts payable invoices and interfaces according to DSI policies. Coordination with purchasing, tax consultants, master data management team, payment specialist, employee requisitioner's, requestors and approvers are required on a daily basis. This position requires the ability to apply independent judgment and critical thinking skills to address difficult issues while meeting deadlines. Receives and addresses escalated or complex questions and issues and escalates further where necessary and as appropriate to bring to timely resolution. Uses independent judgment to resolve escalated issues. Job Description Responsibilities Manage Accounts Payable process including invoices and providing support for all related activities Execution of vendor invoice processing through ERP and AP Automation systems according to company policies Uses discretionary powers to prioritize disbursement activities to optimize cash discount potential Ensure all invoices are simulated against SAP prior to routing for workflow approvals Ensure all foreign vendor invoices are routed to tax department prior to the requestors via automated workflow within Workflow application Support the payment processing by ensuring accuracy of banking information when processing invoices and working jointly with payment specialist and Master Data Management team in resolving issues. Possesses strong knowledge of department policies and procedures as they pertain to the job function Communicates effectively with vendors on payment status requests, general inquiries and account discrepancies in a timely and professional fashion. Works jointly with the payment specialist with the unclaimed property/escheatment process. Includes filing of due diligence letters. Issuing payments to the states. Support various audits by providing invoice and payment support. Provides customer service for shared AP mailboxes within Zendesk. Ensure all inquiries are resolved with our SLA guidelines. Develops and provide training on repetitive problems. Maintain files and documentation in accordance with company policy and accepted accounting practices Assists in system upgrades and related testing Monitor vendor accounts to ensure payments are up to date Assists with month end closing processes including providing monthly AP accruals to finance. Process Patient Reimbursement requests Provide backup processing for DSPD PO/Non-PO invoices Process weekly UPS and PRO Unlimited Interfaces Provide backup support for PGC request processing Resolve invoice processing issues and discrepancies Invoices received without Purchase Order - Vendor follow-up Invoices received with insufficient Purchase Order funding - Requestor follow-up Invoices received with terminated approvers - purchasing coordinator follow-up Invoices received with sales/use tax discrepancies - Tax consultant and purchasing coordinator follow-up Invoices received with banking information and terms differences from vendor master. Master data management and purchasing team follow-up Review and Monitor weekly the Set Aside queue in Esker where actions are logged and followed up on Review and Monitor invoices that remain in approval queue for more than two weeks and reminder requestors accordingly. Elevate issues that remain beyond invoice due date to direct manager. Responsibilities Continued • Prepare and provide monthly dashboard report to Head of Disbursements Execute monthly report of Zendesk tickets created from the mailbox. Categorizing the resolved and open tickets Make recommendations for preventing issues in the future by analyzing the root causes for the issues and assist in bringing those recommendations to fruition Identify any automation opportunities that can prevent the problems from re-occurring in the future and assist in bringing those recommendations to fruition Prepare and provide monthly dashboard report to Head of Disbursements Execute monthly report of Zendesk tickets created from the mailbox. Categorizing the resolved and open tickets Make recommendations for preventing issues in the future by analyzing the root causes for the issues and assist in bringing those recommendations to fruition Identify any automation opportunities that can prevent the problems from re-occurring in the future and assist in bringing those recommendations to fruition Prepare and provide monthly dashboard report to Associate Director - Disbursements Execute monthly report of Zendesk tickets created from the mailbox. Categorizing the resolved and open tickets Qualifications Education Qualifications Bachelor's Degree •4 Year College Degree preferred or 5 years of business experience in the disbursements functions (i.e. Account Payables, T&E, Corporate Card Support). preferred or Experience Qualifications 4 or More Years •5 years preferred of experience in disbursement related activities (without college degree) •Working knowledge of Microsoft Office Suite and various Enterprise Resource Planning (ERP) systems (SAP desired) •Working knowledge with OCR systems such as Esker preferred •Proven track record of issue resolution •Exposure to pharmaceutical industry and PHARMA guidelines •Experience in business related field with customer service background required Travel Requirements Ability to travel up to 5% of the time. Travel for training on infrequent basis - once per year on average Additional Information 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. Salary Range: USD$83,360.00 - USD$125,040.00 Download Our Benefits Summary PDF Read Less
  • Associate Director, Clinical Science  

    - Basking Ridge
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Oversees a clinical trial. Prepares clinical section of regulatory document. Represents Clinical Science on Project Team and collaborates as team member with other functions, AROs/CROs. Provides scientific direction to Clinical Operations and other functions. This position requires minimal supervision to provide critical study-level support to the CSL/PS/MM/GCL for the successful execution of assigned studies. Job Description Responsibilities Study Strategy: Under supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans. Participates in the development of study design to meet study objectives by owning sections/components. Provides strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan and to Clinical Operations on SDV plan. Develops biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP). With Data Management, co-leads or provides input to the Integrated Data Review Plan process. Study Planning and Execution: Provides input on major milestones of trial, clinical trial plan and contingency planning. Analyzes and updates management on potential risks to study deliverables. Leads study team in authoring of protocol and responsible for ICF creation or provides input on ICF creation. Consults and recruits members for DSMB and/or adjudication committee setup and develops supporting documents and charters. Leads development of protocol deviation management plan and contributes to monitoring protocol compliance to ensure proper identification and categorization of protocol deviations. Reviews inclusion/exclusion criteria and other study design elements for consistency with study strategy. Oversees recruitment and retention; establishes and implements contingency plans for shortfalls. Study outputs: Reviews emerging clinical data regularly and shares data review findings with the study team. Performs quality assessment with Delivery Lead e.g. review Tables/Listings/Graphs before database lock and quality check of data; works with BD&O to ensure SAP update. Leads dose-escalation meetings and other site facing interactions with Clinical Operations. Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements. Draft clinical sections of regulatory documents and responses to IRBs and Health Authorities. External collaboration: Consults with internal experts and external KOLs, Ad Boards for protocol development. Provides input on CRO / ARO Statement of Work and Budget; represents Clinical Science in study team meetings with CRO and ARO Establishes effective communication between CRO / vendors / ARO. Additional non-study related activities: Occasional senior management interactions at FIHC, WDC. Initiates contact w/KOL and prepares material for KOL interactions to support study-based needs. Supports due diligence activities related to in-licensing and acquisitions. Qualifications Education Qualifications Bachelor's Degree life sciences or related field required Master's Degree, PharmD, PhD preferred Postgraduate training in TA or related specialty, or equivalent preferred Experience Qualifications 4+ years with PharmD, PhD and relevant clinical experience or 7+ years with Bachelor's degree and relevant clinical experience Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred Travel Requirements In-house office position that may require travel (global). Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$162,400.00 - USD$243,600.00 Download Our Benefits Summary PDF Read Less
  • Senior Director, Clinical Development  

    - Basking Ridge
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides medical and scientific expertise to cross-functional DSI colleagues Job Description Responsibilities Medical Monitoring Provides medical input on study and country feasibility, including site feasibility assessments Contributes to eCRF design, UAT, and CRF Completion Guidelines as needed Conducts ongoing clinical data review and assesses protocol deviations Addresses medical queries from sites/IRBs, including eligibility, safety, dose modifications, and adverse event management Serves as study medical expert and oversees CRO Medical Monitor activities, including data review and medical guidance (e.g., AE coding) Responsibilities Continued Clinical Development Expertise & Strategy Leads development and execution of the Clinical Development Plan (CDP), ensuring alignment with protocols and Target Product Profile (TPP) Provides medical/scientific leadership for study design, protocol development, and key study-level documents (e.g., CSR, IB, regulatory responses) Interprets and presents clinical data to internal and external stakeholders; supports regulatory and safety reporting (e.g., DSUR, PSUR) Delivers scientific training and leads key study meetings (e.g., IM, SIV) on compound, disease, and safety management Maintains deep therapeutic area expertise and contributes to strategic insights on disease landscape, competition, and product positioning (TPP/EPP) Leads engagement with governance bodies (e.g., DMC, Steering Committee), including charter development, presentations, and ongoing oversight Oversees external partnerships (e.g., CROs, AROs, cooperative groups) and contributes to labeling and product lifecycle management Health Authority Interactions & Publications May contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections May support the GCL, if applicable, in planning and executing the overall publication and clinical communication strategy (overall or at the individual trial level), providing input to key external presentations. Contributes to and serves as the medical point of expertise in key Health Authority interactions and Ad board meetings Qualifications Education Qualifications MD required Postgraduate training in TA or related specialty required Experience Qualifications 7 or more years relevant clinical experience required Travel Requirements Ability to travel up to 20% of the time. Domestic and International travel will be 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. Salary Range: USD$280,350.00 - USD$467,250.00 Download Our Benefits Summary PDF Read Less
  • At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI). This includes overseeing the whole clinical supply to support total performance of clinical development in not only oncology but also specialty medicine therapeutic area. This position manages CSO functions in DST, DSI, and DSE and has direct reporting lines from those functions. This position serves as a strategic CSO lead for all global development projects in cooperation with clinicals in R&D, Oncology Business Unit (OBU), Quality & Safety Management, Supply Chain, and other relevant global functions. The position is also responsible for comparator management, especially for oncology projects at the global level. The remit includes to be responsible for establishment, governance and oversight of all clinical supply vendors including, but not limited to, Interactive Response Technology (IRT), labeling, distribution, storage, transfer and destruction. This position supports the Head of Supply Chain Mgmt (SCM) to represent its function at the Technology Unit Steering Committee (TUSC), GPAD, and other decision-making bodies in Daiichi Sankyo Group for making the best decision. This position also helps the Head of Project Lead to be a member of Supply Chain Committee with AstraZeneca (AZ) & Merck Sharp & Dohme (MSD) collaborations. Additionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. The individual in this position requires an advanced level of executive leadership and demonstrates the capability of managing complex relationships among the wide-range stakeholders in the US, Japan, and the EU including both therapeutic areas (Oncology and Specialty Medicine) in R&D and Global Medical Affairs. The position needs to collaborate very closely with various executives in DSI and other legal entitites across Daiichi Sankyo Group. This position will drive organizational changes in alignment with Daiichi Sankyo Group's 2030 Vision and ensure high levels of employees' engagement and productivity. Responsibilities Defines and prioritizes goals, activities, and timelines to deliver on objectives. Leads the strategy for Global CSO, which includes alignment with the global, strategic vision and goal setting, global collaboration, and development of the functional capability. Also leads the vision for Global CSO in alignment with TECH Unit 2030 vision and Daiichi Sankyo Group's 2030 Vision. Ensures stable operation of Clinical Trial Materials (CTM) and comparator management to secure robust supply. Saves the cost of expensive comparators by minimalizing obsolescence of unused comparators. Interfaces closely with internal Clinical Supply partners such as Clinical Operations, Clinical Development, Quality, Regulatory Affairs and External Vendors to ensure that CTM is available as required. Collaborates continuously with Project Lead (CMC) to overcome changes in manufacturing plan that impact CTM supply. Develops and manages Global CSO strategies for all DS projects as the Head of Global CSO and accelerate product launches. Manages CSO functions in DSI, DST, and DSE, through direct reporting lines and manages/coordinates all the CSO-related activities including clinical supply delivery with packaging and labeling, inventory and logistics for all projects globally from early to late development. Key goals are met on time to supply CTMs and comparators without delay. As a part of the SCM-Committee, participate in SCM decision-making processes in cooperation with the Head of SCM Unit. Selects, maintains, develops, and motivates all the staffs in Global-CSO/DSI-CSO who can maintain Daiichi Sankyo's quality and compliance mindset while transforming into an organization that can fulfill Daiichi Sankyo Group's 2030 Vision, and demonstrates the short- and long-term growth of the company. Directs DSI-CSO organizational activities, establish priorities, schedule, and track work assignments, provides guidance, and ensures resource availability as a part of global organizations reporting to Head of SCM. Sets and executes the annual Global-CSO/DSI-CSO objectives with ensuring cascade down to each individual of DSI-CSO. Prepares and be accountable for annual Global-CSO/DSI-CSO budget including comparators through adequately manage expense projections and transparent reporting to the Head of SCM . Supports financial planning for clinical trials including budgeting, forecasting and strategic planning for clinical trials with finance staff to maximize productivity, efficiency and overall business performance. Establishes and maintain effective communication and collaboration with executives / senior management across the Global TECH UNIT Unit to meet department / corporate goals and serve as a cross-functional leader with a wide range of stakeholders. Builds strong partnerships with the Project Lead, Global Project Leader (GTL) in R&D, and DSI executives to maximize the value of DS's portfolio. Qualifications Education Qualifications Bachelor's Degree preferably in a scientific or technical disicipline required. A Master's Degree in Chemistry, Life Sciences, Engineering, in Pharmaceutical or related discipline or a PhD preferred Experience Qualifications Minimum of 15 years industry experience of relevant biotechnology or pharmaceutical industry (Clinical Supply Operations). 12+ years of experience in Clinical Supply Operation or a related pharmaceutical development field globally. Highly experienced working in oncology project development and in cold chain management. Experience in effectively managing cross-functional teams in a matrix organization. required Travel Requirements Ability to travel up to 20% of the time. Domestic and International Travel (Japan, Germany, China) 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. Salary Range: USD$255,000.00 - USD$425,000.00 Download Our Benefits Summary PDF Read Less
  • Senior Director, Clinical Safety Scientist  

    - Basking Ridge
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Senior Director, Clinical Safety Science is a key leadership role responsible for shaping and advancing global safety strategy across the product lifecycle-from early development through post-marketing. This position oversees a team of Safety Scientists who partner with Safety Physicians and cross-functional stakeholders to ensure proactive safety surveillance, benefit-risk assessment, and risk mitigation planning for a group of assets. The Senior Director plays a pivotal role in influencing safety governance, driving innovation in safety science, and ensuring regulatory and compliance excellence. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise. Job Description Responsibilities Strategic Safety Leadership: Provide scientific and strategic leadership for safety surveillance and risk management for a group of assets. Lead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. Team and Talent Development: Lead, mentor, and develop a high-performing team of safety scientists supporting a group of assets. Champion a culture of scientific rigor, continuous learning, and collaboration. Ensure strategic alignment of talent to pipeline priorities, provide performance feedback, and guide professional growth to build future leadership. Innovation and Process Excellence: Maintain strong knowledge of the evolving safety science and regulatory landscape. Drive initiatives to enhance scientific methods, tools, and systems supporting safety surveillance and signal detection. Lead cross-functional and global projects to evolve safety science capabilities. Contribute to strategic planning and operating model design for CSPV. Compliance and Quality Oversight: Ensure all safety deliverables by the scientist team meet internal quality standards and are compliant with GCP/GVP and relevant global regulations. Support audits and inspections, contribute to CAPA development, and foster a culture of quality and accountability. Resource Planning: Partner with CSPV portfolio management and product leads to forecast resource needs for a group of assets and align capacity with business priorities. Leverage metrics to inform decision-making and improve operational efficiency. Qualifications Education Qualifications PharmD or PhD degree in relevant discipline required Experience Qualifications At least 10 years of experience in clinical development, medical affairs or clinical safety/post marketing safety in the pharmaceutical industry required At least 5 years of experience in clinical safety/post marketing safety in the pharmaceutical industry preferred At least 5 years of people management experience required Experience in leading safety scientist teams in clinical studies, regulatory submissions, aggregate reports and post-marketing surveillance and risk management Excellent communication, project management, writing and analytic skills Demonstrated strong organizational leadership skills Extensive knowledge of the latest technical and regulatory development 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. Salary Range: USD$242,700.00 - USD$404,500.00 Download Our Benefits Summary PDF Read Less
  • Senior Director, Clinical Safety MD  

    - Basking Ridge
    At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The Sr. Director, Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership and communication skills to successfully coordinate resources and 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). Job Description Responsibilities Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally. Effectively represent the CSPV on the Global Product Team or other cross-functional teams providing the safety leadership and serving as the primary point of contact. Review and analyze data from clinical trials, post-marketing and other relevant sources for the prompt identification of safety signals. 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. Define and implement strategies and action plans for identifying and managing risks throughout the product life cycle. Effectively coordinate and manage available resources in developing and delivering high-quality safety evaluation related documents/deliverables on time. Coordinate and participate actively in safety-related regulatory interactions (e.g., regulatory meetings, post-approval commitments). Qualifications Education Qualifications MD. Board certification or eligibility required Experience Qualifications 6 or more years of experience in the pharmaceutical industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology 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. Salary Range: USD$280,350.00 - USD$467,250.00 Download Our Benefits Summary PDF Read Less
  • At Daiichi Sankyo, we are united by a single purpose, to improve lives... Read More
    At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Job Summary The candidate for Executive Director, Global Business Development - Transactions will possess a strong business acumen with extensive experience in the life sciences and biopharmaceutical industry particularly in the area of Oncology. Expertise and prior experience in the deal making process in the industry as evidenced by a comprehensive deal sheet indicating prior successful deal leadership to closing across the range of counterparties/collaboration partners typically encountered by the Daiichi Sankyo Transactions team is required. The candidate will lead efforts in partnering/licensing for research, development, and commercialization of therapies with a particular focus in Oncology. The candidate is required to have strong interpersonal skills and work with a multitude of internal/external stakeholders to facilitate highly visible and time-sensitive business development projects. The purpose of this job is to identify, coordinate the assessment of, and help secure pipeline- and portfolio-enhancing, business opportunities (through licensing, acquisition, co-promotion, and other structures.). This role is a primary business development transaction lead for the Oncology Business Unit (OBU)/R&D, and is responsible for overseeing business development opportunities across a range of categories designed to advance the existing pipeline (including strategic collaborations with pharma partners, companion diagnostic deals, combination studies, ARO collaborations, platform licensing, co-development agreements, divestitures and others) as well as to acquire new product opportunities to augment our pipeline. This role is responsible for interacting with senior leadership within R&D as well as CEOs, heads of R&D, etc. as well as at companies with whom we are potentially doing a deal. In leading deal teams, this person is responsible for coordinating with commercial, R&D, legal, intellectual property, finance, supply chain, and other relevant functional area colleagues, at all levels, and across geographies, and is required to lead the diligence and assessment process and take lead responsibility for pulling together a recommendation for presentation to senior management. Externally, the job requires initial meetings with potential partners; coordination of capability presentations; coordination of diligence meetings; leading negotiation sessions; and alliance management participation during and following successful completion of business arrangements. This role also requires one to supervise, train and develop other business development professionals within the Global Business Development function. Job Description Responsibilities Execute assigned transactions through proposal/review/negotiation of NBTS and Definitive Agreements, acting as Lead for many opportunities as assigned by the Vice President Global Business Development Work in concert with key Functional Area Leads (esp. R&D Finance, R&D (Global Project Team Leader), Business Development, Legal and others) and Senior Management Global Business Development/Daiichi Sankyo Corporate in Tokyo to secure alignment on key terms and conditions prior to and during active negotiations. Communicate activities frequently across the organization through related internal approval committees Communications should include sharing of key contract related terms and conditions to key internal stakeholders as well as the related strategic, financial, scientific and commercial rationale for each opportunity reflecting internal analyses as well as diligence activities. Respond to Q&A from Corporate Finance, Tokyo Business Development, Oncology Business Global Oncology Marketing, OBU, R&D, Corporate Business Management, Senior Management, and other key stakeholders as indicated. Meet with other pharmaceutical company licensing groups, participate in industry meetings, conduct proactive product searches, and coordinate search efforts to identify new opportunities to enhance the pipeline as well as in line products. Together with colleagues from Search and Evaluation, coordinate with commercial, R&D, finance, supply chain, intellectual property, legal, etc., on both preliminary and full assessments of potential opportunities, and summarize conclusions and recommendations for discussion with and presentation to senior management. Schedule and lead diligence meetings with potential partners. Provide strategic alliance management for deals to monitor compliance, resolve strategic issues and re-negotiate, if necessary Assure functional excellence by training and development of more junior staff and Direct Report(s). Responsibilities Continued Qualifications Education Qualifications MBA A strong finance focus is preferred. preferred or Master's Degree Consider a Master in Engineering Management or a Master's of Finance with relevant experience. preferred PhD preferred MD preferred JD JD is also acceptable if accompanied by proven expertise in leadership of large transactions. Bachelor's Degree required Experience Qualifications Must have 10+ years of experience within the pharmaceutical industry. Previous Big Pharma experience required. required in leading complex negotiations in a variety of Oncology focused transactions (including multiple major or complex transactions) to closing required Proven ability to manage teams and coach team members' career development. Track record of training and mentoring junior staff. preferred Matrix experience preferred. Branded Oncology transactions experience required Proven financial expertise along with a strong track record of independently leading transactions within oncology. A deal sheet will be required. Companion Diagnostic contracting expertise strongly preferred. Expertise in leading contract negotiations and closing complex, oncology deals required. Proven professional transaction experience should include the leadership of, complex Co-development/ Co-commercialization agreements, joint ventures, as well as clinical trial agreements, material transfer agreements, and divestitures, in/out-licensing, acquisitions, academic research agreements and venture capital investments. required Demonstrate ability to work independently and influence other key business stakeholders both internally and externally. required 10+ years of demonstrated proficiency leading complex negotiations in a variety of Oncology focused transactions (including multiple major or complex transactions) to closing. required Deal sheet reflecting breadth of transaction leadership/success required Travel Requirements Ability to travel up to 30% of the time. Frequent overnight travel as required by the deal process; domestic; some global Additional Information 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. Salary Range: USD$255,000.00 - USD$425,000.00 Download Our Benefits Summary PDF Read Less

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