- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for...role such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant therapeutic experience and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Clinical Operations (GCO) Functional Excellence (FxExc), ... status. In addition, this role will support the FxExc Director in leading innovation and optimization by gathering industry...metrics and trend analysis to key stakeholders in Global Clinical Operations and GDO Leadership, as appropriate.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The global head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations , Data Management, Scientific Operations etc) and ... position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning, regulatory guidance, and in-licensing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …More Years relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry setting required.Experience ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. SummaryThe Site Contracts and Budgets Management (SCBM) group, in Global Clinical Operations (GCO), develops strategy and provides oversight to all ... & Strategy position provides leadership in strategy and process development for Global Clinical Operations (GCO) to ensure the implementation of best practices… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support ... as other research areas centered around rare diseases and immune disorders.SummaryThe Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up, model the way and enable the team to act.Provides medical leadership toGMA clinical operations teams as part of evidence generation forums and study teams ... areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders. Provides ... 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)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of… more
- Insmed Incorporated (Bridgewater, NJ)
- …limited to, the following:Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... a multidisciplinary pharma/diagnostic development team.- Knowledge of the IVD and/or clinical development process is a plus.- Knowledge of molecular diagnostics… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... for the development and control of functional budget in support of global operations of RD unit. Partner with global function leaders to ensure budgets are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in related discipline, or equivalent work experience required.8+ years' experience in clinical operations CRA capacity required.5+ years' experience in proven ... and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required.Demonstrated ability in influencing others in… more
