- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that includes veterans and people with disabilities.Summary Reporting to the Disease Area Strategy Team (DAST) Lead for GYN Cancer, this position is integral to R&D ... DAST Lead to build and execute a disease area strategy across the ADC portfolio plus emerging pipeline assets...critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to end in collaboration with GCLs, Physician Scientists and the study team ( data management , clinical operation and other functions) to implement clinical ... programs. Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management , Regulatory Affairs, and other RD functions to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... the effective strategy , design, execution, and interpretation of Oncology clinical trials....and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.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....and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …excellence in managing multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy , US Oncology Medical Affairs ... medical education strategies for independent grants, respectively. Provides input into publication strategy , data gap analysis, and tactical planning as part of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as ... to drive the vision and implementation of Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...or indication.ResponsibilitiesLeads the development of the Global Medical Affairs strategy and execution of the Global Medical Affairs plan… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related projects). Collaborate with Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Merck & Co. (Rahway, NJ)
- …Executive Director / Director /Associate Director , Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), the incumbent is responsible for PV ... and support processes that facilitate achievement of GCS&PV objectives.The Associate Director may also have people management responsibilities related to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... regulatory strategy ; Drafts protocol profiles and sections of key submission...the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CDISC ADaM data set specifications, reviewer's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads ... implementation of vision and strategy , and identifies technology needs for the function to...leadership for strategic and process improvement initiatives within Biostatistics Data Management . Works with colleagues at DST… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and ... regulatory strategy ; Drafts protocol profiles and sections of key submission...the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as an ad hoc member ... in support of business objectives.ResponsibilitiesPreparation of new and updated Core Data Sheets, EU and US Documentation: As the project lead, Independently… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of CROs and provides oversight of CRO/sponsor partnership. Sets the vision and strategy for the function. Accountable for the management , performance, and ... portfolio or specific therapeutic areas from Phase 1 through life cycle management . Provides oversight of statistical activities performed by direct reports or staff… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Strategy , Global Forecasting & Insights and Global Project Management . Successful execution will involve working cross-functionally to gather relevant ... and develop comprehensive opportunity assessments consistent with our corporate business development strategy . This position may lead a small team and will report to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy : Provides the strategic direction to Biostats Data Mgmt ... & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan;...patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy in collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, ... Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology, ... Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project… more
- Merck & Co. (Rahway, NJ)
- …companion animal species. About the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all ... from senior management to tactical execution- to understand customer master data management needs. With an increased focus on Commercial, Sales, and… more
