- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position is a Clinical Science lead position and will lead a group of clinical scientists organized ... size of the asset program. This Clinical Science (CS) lead will be responsible for leading and managing one...Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also contribute to the program study strategy,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in Global Medical Affairs committees as requested. Serves as US Medical Affairs Lead , to gain strategic and planning alignment across the matrix team and the ... related USOMA plan/budget for related MA activities Demonstrated ability to lead and influence others internally and externally. Experience leading matrix medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support Clinical Inspection Readiness (IR) and ... pre-approval Inspection preparation activities for global clinical operations, responsible for representing the GCO-CQM inspection readiness within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex and/or late-stage project or act as main CMC … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to global Development governance. In this key role, the candidate will have to lead a complex, global team in charge of a global clinical program designed to ... representative of asset through the lifecycle from research to post-marketing functions. Lead all GPT meetings, ensure team and cross functional alignment, positive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and ... agreed to by management 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 requiredExtensive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... implementations in partnership with Global DX, and QA-CSV/eCompliance team members to ensure compliant, efficient and timely completion of global DX GxP and Non-GxP CSV projects. Define validation activities, timelines and resource requirements for CSV… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise to drive the success of the asset. The individual will lead global pricing strategy development, access strategy development and partner with stakeholders ... Commercial, Marketing, Medical, & Clinical Development,ResponsibilitiesGlobal Market Access Strategy- Lead the development of pricing, reimbursement and access strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site-Launch activities and associated teams for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical path ... for assigned clinical study (-ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross-functional Clinical Study Oversight Plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan including critical ... and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross functional Clinical Study Oversight… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables are met. The key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an Inclusive Research and Patient ... to support best in class diversity and patient voice planning, 3) Design, lead and implement the GCO delivery framework for diversity and patient voice plans… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of...new products or products in the development phase. Independently lead cross functional teams through all labeling discussions with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will ... Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset Leads who… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration to meet the ever-changing global needs for Daiichi Sankyo. Will lead project and change management for complex, cross-functional initiatives for global ... process improvement, change management and analytics. In addition, this position will lead and support divisional and departmental level objectives for Asset &… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in all aspects of medical review, providing expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and scientific ... Serve as integral member of the Medical Affairs Teams for assigned TA.Proactively lead effective coordination and alignment between medical review and other MIE and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …efficiency and decision making.Responsibilities Project ResponsibilitiesIndependently manage or lead strategy development for high complexity drug development ... maintaining a high performing team.Generate critical path analyses and lead scenario planning with GPT to select best option...junior PMs, Team members and project stakeholders.As a TA lead or Lead on a Business Collaboration,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring ... assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of Forecasting/Business… more
