- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on ... management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their… 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 ... file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic… 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 & ... oversight standard practices across GCO and work with Global Clinical Operations , as needed, to understand business priorities.Develop and establish more streamlined… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part of ... the Technical Operations team based in Raritan, New Jersey. Role Overview...This individual is required to manage a global strategic operations to ensure that available and future capacity can… more
- Merck & Co. (Rahway, NJ)
- …Tax We are seeking an experienced tax professional to join our team as an Associate Director of Tax Operations .The Associate Director of Tax Operations ... will report to the Director of Tax Operations and will work closely with various internal departments,...a variety of tasks and projects related to tax operations and ensure the delivery of high-quality work products… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to collaborate with, and support the head of Global QA strategy and operations . In this position, the incumbent will take on organizational responsibilities relevant ... tasked under the direction of the Global Strategy and Operations Head, to draft presentation for VP of QA,...and allow decision making.Responsibilities- Support Head, Global strategy and operations on projects needing to be coordinated with both… more
- Merck & Co. (Rahway, NJ)
- …overall success of the pilot plant. The Facility Lead position reports to the Director of Operations /Head of SSO Pilot Plant and the successful candidate will ... technical, and operational experience to lead and support facility operations , process development activities, compliance investigations/change management, authoring of… 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 ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is ... leading all planning activities for Daiichi Sankyo major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to… 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 ... of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a Liaison between ... MARS and RD Line Functions for promotion of Metrics and Dashboards strategy.Team Management Manage the Metrics Business Analyst Team Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liasions to ensure sucessful implementation ... of CDx and data collectionSupports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping… 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 ... 10 years' experience in pharmaceutical or biotechnology across clinical trial operations . Experience in training, process improvement, and project management a plus.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...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)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and ... assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.- Participates in meetings with Health… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.SummaryThe primary responsibilities of the Associate Director , Omni-Channel Marketing is to develop, plan and implement the ... inputs to decisions on business strategy given market dynamics. The Associate Director should support smooth execution of all omnichannel platforms, tools and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) and external partnerships ... to achieve the objectives of the global regulated bioanalysis group. The global head will also set the outsourcing strategy for the regulated bioanalytical sciences and will lead regulatory interactions related to bioanalysis and evaluates/sets the strategy… more
