- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning is responsible for ... but not limited to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory Operations in developing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on ... at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub...addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant to ... art technology systems necessary to complete tasks and allow decision making.Responsibilities- Support Head, Global strategy and operations on projects needing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial Operational Risk & ... ways of working, tools, and meaningful communication pathways with functional partners to support GCO risks. This individual will also lead and manage the GCO CTOR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life ... and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in a global matrix of biomarker and translational scientists and clinical operations . The candidate must have effective project management skills and communicate ... Translational Scientists, Companion Diagnostic Scientists and Clinical Scientists and Operations Leads in the review of clinical protocols, laboratory instructions,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This role ... 2) Identify innovative approaches, industry best practices, tools, and data strategies to support best in class diversity and patient voice planning, 3) Design, lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and resources for the assigned GMA plan activities, in collaboration with Sr Director . Support medical readiness activities for market launches and life cycle ... and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will be responsible for lifecycle ... RM oversight tools, management, and maintenance), and provide day-to-day operational risk support to study teams and their line management to ensure prevention of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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. ... closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure sucessful implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and ... siRANdrug projects consistent with the company goals. Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools ... rare diseases and immune disorders.SummaryThe primary responsibilities of the Associate Director , Omni-Channel Marketing is to develop, plan and implement the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Job Summary:The Associate Director of Digital and Omnichannel Analytics Technology is responsible for leading ... cross-functional teams, including Omnichannel Center of Excellence, marketing, business operations and market access to implement data collection methodologies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mentors and may manage assigned staff, partnering with the Global Labeling Operations & Compliance group and across the cross-functional and cross- regional ... business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Operations and other cross-functional and regional stakeholders. Provides support in review of investigator-initiated studies (IIS) and may serve as ... research areas centered around rare diseases and immune disorders. Job Summary:The Director , Global Medical Affairs (GMA), Gyn Oncology, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational processes and identifying the latest digital tools and technologies to support MCT activities. The Director serves as primary functional partner ... other research areas centered around rare diseases and immune disorders.SummaryThe Director , Medical Content & Training (MCT) Excellence and Innovation is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will also serve as the Clinical Science… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, ... and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, Regulatory Affairs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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. ... closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure successful implementation… more
