Jobs at Daiichi Sankyo
2,115 open positions
Associate Director, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 14, 2024
<p><b>Join a Legacy of Innovation 110 Years and Counting<b> <p> <p>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 worldclass science and technology With more than 100 years of scientific expertise and a presence in more than 20 countries Daiichi Sankyo and its 15000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people Under the Groups 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 <p> <p><b>Summary<b> <p> <p>The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission It will also improve Daiichi Sankyo programming efficiency by developing tools and macros and build up standard on SDTMADaM datasets and TFLs <p> <p><b>Responsibilities<b> <p> <p> Supporting project lead on outsourced projects act as statistical programming subject matter expert SME to support outsourced programming activities and be responsible for the programming technical decision By guiding other internal programmer or by self perform programmatic review of Study Date Tabulation Model SDTM and analysis including Analysis Data Model ADaM datasets as well as TLFs generated by statistical vendor ensure correct and effective vendor programming implementation and expedite the preparation of regulatory submissions Responsibilities include make strategic programming decision and planning review Case Report Form CRF annotation and SDTM dataset identify data inconsistencies and support data review review analysis dataset specifications and ensure correct interpretation of SAP develop independent programs to validate stud level analysis dataset and TLFs generated by vendor ensure analysis dataset in compliance with CDISC and submission requirement review study submission data package and ensure its quality and integrity <p> <p> Provide handson statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies Responsibilities include develop programming submission strategy perform integrated analysis of efficacy and safety generate submission data package create TLFs to support submission QAs perform adhoc and exploratory analysis requested by clinical team and support agency response or potential Advisory Committee Meeting <p> <p> Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality Responsibilities include contribute to CRF and SDTM standard development develop implement and maintain SDTM ADaM dataset and TLF standard develop sample programs to generate and validate SDTM ADaM dataset and TLFs support technical training and ensure effective implementation of SDTM ADaM and TLFs standard in clinical trial data analysis <p> <p> Develop and maintain necessary programming macros or tools to effectively support all programming needs Responsibilities include identify the macros or tools that will facilitate programing efficiency lead the macro or tool development by working with contractors or by self and support the macro or tool implementation and maintenance <p> <p> Evaluate assess and enhance DSI computing environment system Responsibilities include continue assessing DSI new computing environment system for programming and analysis efficiency identify system bugissue and lead the activity to enhance the system develop system training materials and work as the SME to support implementation evaluate request and approve system upgrades and proposedevelop system utilities <p> <p><b>Qualifications<b> Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation <p> <p><b>Education Qualifications from an accredited college or university<b> <p> <p> Bachelors Degree an accredited institution in a science or in a technical field preferred <p> <p> Masters Degree preferred <p> <p><b>Experience Qualifications<b> <p> <p> 10 or More Years proven experience within pharmaceutical industry or CROs supporting statistical analysis of clinical trials programming with Bachelors preferred <p> <p> 7 or More Years proven experience within pharmaceutical industry or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred <p> <p> Previous experience supporting SAS macro andor system utility development preferred <p> <p> Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred <p> <p> Advanced working knowledge of CDISC SDTM and ADaM and extensive experiences of their implementation in clinical trials analysis preferred <p> <p> Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred <p> <p> Knowledge of all phases of drug development including early and late phase clinical development and submission preferred <p> <p> Solid background in applied statistics preferred <p> <p> Solid knowledge of new advanced statistical methods using SAS and R preferred <p> <p> Advanced knowledge in database structures and setup preferred <p> <p>Daiichi Sankyo Inc is an equal opportunityaffirmative 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<p>
Manager, Data Programming & Reporting
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 15, 2024
<p><b>Join a Legacy of Innovation 110 Years and Counting<b> <p> <p>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 worldclass science and technology With more than 100 years of scientific expertise and a presence in more than 20 countries Daiichi Sankyo and its 16000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people Under the Groups 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 <p> <p><b>Job Summary<b> <p> <p>The Manager Data Programming amp Reporting is a member of the Biostatistics and Data Management team and serves as a subject matter expert for Clinical Data Programming Reporting Process and technology Accountable for the quality and delivery of the Data Management programming reporting and visualization standard and exception data listings across studies Scope of work includes oversight and expertise in the design development and validation of programs standard and adhoc reports standard and exception data listings and visualizations to support ongoing data review activities achieve critical study milestones and gain data insights into our clinical studies The position requires good understanding of programming methods and techniques critical thinking and complex problemsolving skills This position will require strong collaboration in working with other members of the Biostatistics and Data Management external CRO partners and other stakeholders <p> <p><b>Responsibilities <b> <p> <ul><li>Serve as a subject matter expert and provide expertise for Database programming Reporting and Technology and optimize the use of JReview ETL SAS tools and others to support business needs<li> <li>Manage the quality of the data management clinical database programming deliverables including edit checks programming complex reports and listings patient profiles subject narratives exception listings dose modification reports and other adhoc reports using JReview amp SAS as part of standard data validation and reporting package for clinical studies<li> <li>Develop andor provide oversight on the programming specifications for the data validation and reporting deliverables code test and document deliverables conforming to programming standards data quality and governance and validation policies <li> <li>Partner with internal and external stakeholders to ensure timely delivery of data management programming EDC database external data data management programming of reports and listings including the use of visualization tools<li> <li>Design and develop macros applications and other utilities to expedite JReviewSAS programming activities <li> <li>Develop standard programs templates reports data listings discrepancy reports and patient profiles to facilitate in the ongoing review of clinical data during study conduct and study closeout<li> <li>Build test and scaleup programs for data validation derivation procedures data reports listings and SAS on Demand relational database extracts for operational use identification of data outliers quality inconsistencies and preparation for analysis<li> <li>Provide technical guidance and direct programming tasks for Medical Coding activities<li> <li>Provide Clinical Programming expertise and support for critical and timesensitive study milestones including interim analysis and database lock activities <li> <li>Perform ETL tasks enhancements validation and maintenance of the programs and templates on an ongoing basis<li> <li>Perform QC lead unit testing activities develop validation scripts for user acceptance manage and execute programs and dry runs as needed and resolve programming issues proactively <li> <li>Develop and maintain mapping and program specifications for standard reports listings and visualizations<li> <li>Maintain database programming checklists and trackers to ensure conformance of highquality deliverables with the study data validation and reporting package<li> <li>Establish and implement programming standards and comply with regulatory requirements among project team members and across all studies<li> <li>Participate in the development of and ensure compliance to Standard Operating Procedures SOPs policies and guidelines <li> <ul><p><b>Qualifications<b> What are the minimum requirements for the position <p> <p><b>Education<b> <p> <ul><li>BABS degree required MS or equivalent degree preferable<li> <ul><p><b>Experience<b> <p> <ul><li>Minimum of 5 years database programming experience and data validation programming in the devicepharmaceuticalCRO industry<li> <li>Expertise in Clinical Programming methods and techniques<li> <li>Expertise in using standard reporting and data visualization tools including JReview and SAS tools<li> <li>Knowledge of industry standard clinical technologies including CTMS EDC RAVE InForm<li> <li>Knowledge of CDISC data standards<li> <li>Knowledge and understanding of relational databases<li> <ul><p><b>Competencies<b> <p> <ul><li>Clinical Programming Project Management and Technical Expertise<li> <li>Knowledge of logical data design and data mapping<li> <li>Knowledge of reporting and data visualization tools JReview Spotfire SAS suite and ETL technology<li> <li>Experience with programming development validation execution maintenance documentation and archival of clinical data for regulatory submission is required<li> <li>Proficient in industry standards medical terminology and clinical trial methodologies<li> <ul><p>Daiichi Sankyo Inc is an equal opportunityaffirmative 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<p>
Manager, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Dec 08, 2023
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. preferred - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials. Responsibilities include: contribute to CRF and SDTM standard development, support develop, implement, and maintain Analysis Data Model (ADaM) dataset and TLF standard, develop sample programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis - Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in response to regulatory agencies. preferred - Having knowledge of all phases of drug development, including early and late phase clinical development and submission preferred - Having solid background of applied statistics preferred - Solid knowledge of new advanced statistical methods using SAS preferred - Knowledge in database structures and set-up preferred - The candidate should have successfully provided programming expertise at the Project level for at least two global development projects that have been submitted to regulatory agencies preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Education Qualifications (from an accredited college or university) - Bachelor's Degree from an accredited institution in science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Bachelor's degree preferred - 4 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred - Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming. Responsibilities include: create TLFs to support submission QAs in a quick turnaround, support ad-hoc and exploratory analysis requested by clinical team, provide programming supports in agency response or potential Advisory Committee Meeting - Develop and maintain programming macros to effectively support internal data review and monitoring. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review submission data package and ensure its quality and integrity - Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines met. Responsibilities include: review and agree on vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs transfers for ongoing and complete trials, confirm data use and output quality, proactively ensure the resolution of programming related issues prior to database lock analysis, be accountable and verify completeness of study programming deliverables, maintain all required study programming documentation required for Trial Master File (TMF) - Maintain institutional knowledge across oncology compounds and support building up oncology programming standard on datasets and TFLs to improve efficiency and quality. Responsibilities - By leading internal programming contractor or by self, perform programmatic review of analysis datasets and TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies, Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: work with Biostatistics member to define the requirements of efficacy data review, develop macros and support the internal data review and monitoring on an ongoing basis Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Director, Statistical Programming
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 09, 2024
Daiichi Sankyo Group, a global pharmaceutical company with over 100 years of experience, is seeking a Statistical Programming Manager. The role involves managing outsourced statistical programming, ensuring high-quality deliverables, and leading global harmonization of programming processes. The candidate should have a Master's Degree, extensive experience in the pharmaceutical industry, and proficiency in CDISC. Responsibilities include managing CROs, interacting with global health authorities, and leading strategic initiatives in Biostatistics Data Management.
Senior Director, Epidemiology Analytics
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 08, 2024
Daiichi Sankyo Group, a global pharmaceutical company with over 100 years of experience, is seeking a statistician to lead epidemiology data analysis activities. The role involves designing and implementing statistical analysis plans, reporting research studies, providing consultation on data analysis, and managing relationships with internal and external stakeholders. The position requires advanced SAS programming skills, 10+ years of statistics experience, and 4+ years in the pharmaceutical industry. Experience in drug safety data analysis, oncology data analysis, and managing direct reports is preferred. The role involves contributing to the scientific literature, presenting at professional meetings, and mentoring junior staff.
Manager, Data Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 16, 2024
<p><b>Join a Legacy of Innovation 110 Years and Counting<b> <p> <p>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 worldclass science and technology With more than 100 years of scientific expertise and a presence in more than 20 countries Daiichi Sankyo and its 15000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people Under the Groups 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 <p> <p>Summary <p> <p>Position manages endtoend delivery of data management services for assigned projectsstudies collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions This position also partners with internal and external stakeholders to optimize Data Management technology processes and standards <p> <p>This position has a working knowledge of Electronic Data Capturerelated applications and industry standards and moderate technical skills in working with data received from CROs and other third party vendors This position has strong verbalwritten skills analytical organizational and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures Additionally this position possesses a working knowledge of clinical operations and relevant regulatory requirements This position has experience working on Phase IIV studies within the medical device andor pharmaceutical industry within one or more therapeutic areas Finally this position has moderate skills in continuous improvement project management change management and risk management <p> <p>Responsibilities <p> <ul><li>Leadership Direction and Strategy <ul><li>Establishes Data Management strategy at the project andor study level for a smaller number of projectsstudies Proactively identifies and manages risks at the project andor study level for a smaller number of projectsstudies<li> <ul><li> <ul><ul><li>Project Management <ul><li>Plans and directs the conduct of Data Management activities for assigned projectsstudies through outsourcing eg study startup study conduct study closeout and reporting<li> <li>Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol externalinternal standards Good Clinical Practices GCPs applicable regulatory guidelines Policies SOPs and other relevant guidelines<li> <li>Ensures Data Management deliverables meetexceed projectstudy team expectations regarding quality time and cost and that Data Management documentation is filedarchived according to applicable Daiichi Sankyo and regulatory requirements<li> <ul><li> <ul><ul><li>Functional Expertise <ul><li>Reviewsapproves clinical study related documents eg Protocols Data Management Plan Clinical Study Reports<li> <li>Leads and drives the data review process in collaboration with the study team to ensure data quality<li> <li>Participates in audits and inspections<li> <ul><li> <ul><ul><li>Operational Efficiency Continuous Improvement <ul><li>Provides comprehensive data management expertise to projectstudy teams to optimize studyspecific clinical trial processes<li> <li>May participate in process improvement initiatives<li> <ul><li> <ul><p><b>Qualifications<b> Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation <p> <p>Education Qualifications from an accredited college or university <p> <ul><li>Masters Degree in life sciences or related field or equivalent experience preferred<li> <li>Bachelors Degree in life sciences or related field or equivalent experience required<li> <ul><p>Experience Qualifications <p> <ul><li>4+ years of data management andor related industry work experience in a medical device pharmaceutical company or similar environment eg CRO required<li> <ul><p>Daiichi Sankyo Inc is an equal opportunityaffirmative 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<p>
Director, Strategic Initiatives & Global Project Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 12, 2024
<p>Join a Legacy of Innovation 110 Years and Counting <p> <p>Company is committed to diversity and inclusion We are an equal opportunity employer including veterans and people with disabilities <p> <p><b>Summary <b>The Director GPMampL drives development and execution of programs projects and strategic initiatives for Daiichi Sankyo global RampD function The Director will be able to independently define and execute on our strategic initiatives work across the organization and with senior leaders to ensure input and collaboration to meet the everchanging global needs for Daiichi Sankyo Will lead project and change management for complex crossfunctional initiatives for global teams and workstreams ensuring comprehensive understanding of business and stakeholder needs planning and optimal execution and adoption within the business Includes regular communications and presentations with senior leaders and executive forum presentations Assignments include strategy enablement leveraging multiple skill sets such as project management process improvement change management and analytics In addition this position will lead and support divisional and departmental level objectives for Asset amp Portfolio Management Will also provide innovative thinking to ensure solutions are successfully adopted within the organization The Director will provide oversight and guidance to 23 direct reports in addition to other crossfunctional team members Ensure interactions and timely collaboration across RampD key stakeholders and supporting functions Proactively identify and facilitate risks mitigations resolution and escalation of issues tracking and communicating status to stakeholders and group leadership Strong communications skills required with the ability to engage with senior leaders through various communication mechanisms and presentations The successful candidate has a solid understanding of the drug development process and is skilled in the use of project management tools Experience working on global crossfunctional teams as well as an understanding of facilitating highfunctioning teams <p> <p>Responsibilities <p> <p><b>Strategy <b> <p> <ul><li>Understand organizational strategy independently define manage and lead the implementation of the strategic objectives<li> <li>Provide thoughtleadership and innovative ways to support strategic execution for the organization<li> <li>Ability to influence and align with high level stakeholders to ensure business alignment and the change is successfully embedded within the business<li> <ul><p><b>Project Management<b> <p> <ul><li>Ability to work independently across multiple stakeholder groups identify and manage decisions and escalations to senior leadership<li> <li>Collaborate with global crossfunctional project teams to define project scope deliverables responsibilities and timelines<li> <li>Prioritize work effort and lead multiple project teams to drive completion of deliverables<li> <li>Communicate with senior leaders and conduct Executive presentations<li> <ul><p><b>Change Management<b> <p> <ul><li>Lead the approach and requirements for change management and communications for the implementation of the initiatives owned by the SIG team within APM<li> <li>Identify the needs and define the content required to support change management communications and training needs eg stakeholder analysis training requirements stakeholder communications to ensure successful implementation within the business<li> <li>Collaborate with change leaders across the organization to ensure harmonization with the approach addressing crossfunctional business impacts dependencies and interdependencies<li> <ul><p><b>Process Improvement<b> <p> <ul><li>Ability to identify and lead process improvement efforts across the organization<li> <li>Provide strategic input and facilitate workshops to define current state future state and process gaps<li> <ul><p><b>Analytics<b> <p> <ul><li>Define needs and lead the delivery of senior level management reports and dashboards<li> <li>Understand survey tools and metrics and how to deploy across the initiatives to monitor performance of improvements<li> <ul><p><b>People Management and Leadership<b> <p> <ul><li>Direct oversight of gt2 direct reports<li> <li>Attract hire retain coach develop and promote talent individuals to exceed expectations in delivering on company business objectives<li> <li>Coach and support individual development of team<li> <li>Provide feedback coaching support and recognition to direct reports including objective setting midyear assessment yearend review<li> <li>Foster a positive work environment where different work styles and approaches that still meet individual and team objectives are sought out and encouraged<li> <ul><p><b>Qualifications <b>Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation <p> <p><b>Education Qualifications <b>from an accredited college or university <p> <p> Bachelors Degree Bachelors degree in science engineering or business required <p> <p> Masters Degree Advanced degree in science or business preferred preferred Experience Qualifications <p> <p> 10 or More Years 1012+ years relevant project and change management process improvement business analysis or consulting experience required <p> <p> Prior work experience as a top tier management consultant project and change manager or similar role in pharmaceutical drug development desirable Project Management Change Management or Process improvement qualification certification or diploma is highly desired preferred <p> <p> Scientific background desirable preferred <p> <p> Knowledge of pharmaceutical industrydrug development preferred preferred <p> <p>Daiichi Sankyo Inc is an equal opportunityaffirmative 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<p>
Manager, Data Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Dec 10, 2023
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. Functional Expertise: Reviews/approves clinical study related documents (e.g., Protocols, Data Management Plan, Clinical Study Reports). Experience Qualifications 4 or more years data management and/or related industry work experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO) preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements. Responsibilities Leadership, Direction, and Strategy: Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies Project Management: Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting). May participate in process improvement initiatives. Operational Efficiency / Continuous Improvement: Provides comprehensive data management expertise to project/study teams to optimize study-specific clinical trial processes. Education Qualifications (from an accredited college or university) Master's Degree in life sciences or related field (or equivalent experience) preferred Bachelor's Degree in life sciences or related field required RN in life sciences or related field (or equivalent experience) will be considered.
Director, Informatics
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 09, 2024
The job posting is for a Research & Development informatics systems and programs manager at Daiichi Sankyo. The role involves developing and implementing R&D informatics systems, providing strategic business partnership, and overseeing informatics projects.
Associate Director, Strategic Initiatives & Global Project Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 12, 2024
<p>Join a Legacy of Innovation 110 Years and Counting <p> <p>Company is committed to diversity and inclusion We are an equal opportunity employer including veterans and people with disabilities <p> <p><b>Summary<b> <p> <p>The Associate Director GPMampL drives development and execution of programs projects and strategic initiatives for Daiichi Sankyo global RampD function Ability to lead independently and support project and change management for complex crossfunctional initiatives for global teams and workstreams ensuring comprehensive understanding of business and stakeholder needs planning and optimal execution and adoption within the business Assignments include strategy enablement such as capabilities and processes leveraging multiple skill sets in project management process improvement change management and analytics This position will also lead and support divisional and departmental level objectives for Asset amp Portfolio Management The Associate Director may provide oversight and guidance to 12 team members supporting the initiatives Ensure interactions and timely collaboration across RampD key stakeholders and supporting functions Proactively identify and facilitate risks mitigations resolution and escalation of issues tracking and communicating status to stakeholders and group leadership Strong communications skills required with the ability to engage with senior leaders through various communication mechanisms and presentations The successful candidate has a solid understanding of the drug development process and is skilled in the use of project management tools Experience working on global crossfunctional teams as well as an understanding of facilitating highfunctioning teams <p> <p><b>Responsibilities<b> <p> <p><b>Project Management<b> <p> <ul><li>Collaborate with global crossfunctional project teams to define project scope deliverables responsibilities and timelines<li> <li>Prioritize work effort and lead project teams to drive completion of deliverables<li> <li>Ability to work independently across multiple stakeholder groups identify and manage decisions and escalations to senior leadership<li> <li>Develop and manage status reports project plans actions risks meeting agendas and minutes<li> <li>Create draft deliverables and Executive presentations in collaboration with business SMEs communicate with present to senior leaders<li> <ul><p><b> Process Improvement<b> <p> <ul><li>Ability to define and document processes critically analyze and define areas for improvement<li> <li>Facilitate workshops to define current state future state and process gaps<li> <li>Lead and develop new processes ways of working and support the implementation within the business<li> <ul><p><b> Change Management<b> <p> <ul><li>Identify the needs and define the content required to support change management communications and training needs eg stakeholder analysis training requirements stakeholder communications to ensure successful implementation within the business<li> <li>Collaborate with change leaders across the organization to ensure harmonization with the approach addressing crossfunctional business impacts dependencies and interdependencies<li> <ul><p><b>Strategy<b> <p> <ul><li>Understand organizational strategy and how to enable the implementation of the strategic objectives<li> <li>Research and assess innovative ways to support strategic execution for the organization<li> <ul><p><b>Analytics<b> <p> <ul><li>Define drive and develop models in Excel or Business Intelligence tools for project needs<li> <li>Define drive and develop management reports and dashboards<li> <li>Understand survey tools and metrics and how to deploy across the initiatives to monitor performance of improvements<li> <ul><p><b>Qualifications<b> Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation <p> <p>Education Qualifications from an accredited college or university <p> <p> Bachelors Degree in science engineering or business required <p> <p> Masters Degree Advanced degree in science or business preferred preferred Experience Qualifications <p> <p> 7 or More Years 710+ years relevant project management process improvement business analysis or consulting experience required <p> <p> Prior work experience as a top tier management consultant project manager or similar role in pharmaceutical drug development desirable Project Management process improvement change management qualification certification or diploma is highly desired Knowledge of pharmaceutical industry drug development preferred Scientific background desirable preferred <p> <p>Daiichi Sankyo Inc is an equal opportunityaffirmative 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<p>
Sr. Director, Global Project Management
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 06, 2024
Daiichi Sankyo Group, a global pharmaceutical company with over 100 years of experience, is dedicated to creating innovative therapies for diverse medical needs. The company is primarily focused on oncology, rare diseases, and immune disorders. The Sr Director GPM&L is responsible for managing high complexity drug development projects, leading a team of project managers, and contributing to portfolio management. The role requires a minimum of 12 years of experience in drug development project management, leadership, and people management. A certified Project Management Professional (PMP) is preferred.
Senior Scientist/Associate Director RACMC
Company: Daiichi Sankyo
Location: Other US Location
Posted Mar 06, 2024
<p><b>Join a Legacy of Innovation 110 Years and Counting<b> <p> <p>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 worldclass science and technology With more than 100 years of scientific expertise and a presence in more than 20 countries Daiichi Sankyo and its 16000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people Under the Groups 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 <p> <p><b>Summary<b> <p> <p>The Associate Director RACMC Portfolio Products will be responsible for regulatory CMC Chemistry Manufacturing and Controls activities of the portfolio small molecule and biological drug products consistent with the company goals specifically for the lifecycle management of NDAsBLAs This individual will be responsible for working on crossfunctional teams developing and executing postapproval Regulatory CMC strategies reviewing CMC information and data authoring CMC submissions and interacting with Health Authorities to meet the aggressive timelines for the assigned projects The individual will also contribute to regulatory process optimizations on relevant topics <p> <p><b>Responsibilities<b> <p> <p> Supports CMC regulatory compliance activities for portfolio biologics to meet US International Conference on Harmonization ICH and other applicable regulations This includes preparation review and approval of CMC documentation for BLA Supplements PAS CBE0 CBE30 Annual reports Lot Distribution Reports Biological Product Deviation Reports and Drug Listings Ensures that CMC documentation is complete well organized scientifically sound of a high quality aligned with the current regulations and presented in a manner that facilitates Health Authority reviews <p> <p> Supports company`s GMP Change Management Program Evaluates CMC changes for portfolio biologics and determines filing strategies provides expertise as regulatory CMC representative to project teams and supports change implementation Coordinates with regionalglobal RACMC Quality Assurance Pharmaceutical Technology and other functional areas to secure approval of CMC changes and assess regulatory implications <p> <p> Participates in meetings with FDA Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes Coordinates preparation authors and finalizes meeting materials to include meeting requests briefing books and meeting minutes <p> <p> Works with cross functional teams and various departments to include Marketing Medical Affairs Regulatory Affairs Supply Chain Technical Operations Pharmaceutical Technology and others where applicable Identifies areas for process procedure improvements and works on improvement implementation Provides training on evolving regulations <p> <p><b>Qualifications<b> Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation <p> <p><b>Education Qualifications from an accredited college or university<b> <p> <p> Bachelors Degree Life science required and <p> <p> Masters Degree Life science preferred and <p> <p> PhD Life science preferred <p> <p><b>Experience Qualifications<b> <p> <p> 7 or More Years 8+ years in pharmaceuticalbiopharmaceutical industry experience with a focus on small molecules and monoclonal antibodiesmonoclonal antibody drug conjugates Hands on experience in authoring CTD Modules 2 and 3 documents for small molecules and biologics A proven record of supplemental NDABLA submissions and NDABLA Annual Reports The candidate should be detailoriented selfmotivated and be comfortable with broad responsibilities in an entrepreneurial fastpaced environment required and <p> <p> 6+ years of direct regulatory experience working with NDAsBLAs preferred <p> <p> 4+ years of prior employment with FDA preferred <p> <p><b>Travel<b> <p> <p>Ability to travel up to 10 Domestic or international travel <p> <p>Daiichi Sankyo Inc is an equal opportunityaffirmative 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<p>