- 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)
- …trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry… more
- Insmed Incorporated (San Diego, CA)
- …Millennials™ lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project ... be limited to, the following: Provide management across multiple studies and clinical operations aspects of gene therapy programs.Responsible for the development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Director , Global Clinical Operations (GCO) Clinical Trial ... oversight standard practices across GCO and work with Global Clinical Operations , as needed, to understand business priorities.Develop and establish more… 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 ... and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management,...biotechnology experience in one or more key functions (eg clinical operations , clinical research, … more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member of ... the Clinical Business Operations team within Development Operations and provides oversight and leadership across clinical programs/trials in areas of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. ... of 7 years of experience required Experience Qualifications.7 or More Years 7 years clinical operations experience in trial diversity and patient access and/or … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk (CTOR), will ... plus. required Experience QualificationsStrong experience and expertise in end-to-end clinical operations functional understanding and execution, including… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...your employment may pose an undue burden to business operations , in which case you may not be offered… 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
- Insmed Incorporated (Bridgewater, NJ)
- …to, the following: Provides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operations personnel on clinical ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …limited to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will also serve as the ... in one or several programs.Partner and collaborate with RD leaders in Clinical Operations , Biostatistics and Data Management, Regulatory Affairs, and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OED; considers relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes ... Collaboration: Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner closely with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... medical topics, and supports PV Operations ' medical review function. This position supports a senior...board eligibility preferred Experience Qualifications1 or More Years of clinical experience preferred Daiichi Sankyo, Inc. is an equal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director will work closely with cross-functional project teams, including Clinical Development, Clinical Operations , Biometrics, and Regulatory Affairs ... clinical development and regulatory requirements of a clinical program. The Director will provide high...Writing team. Essential Functions Provides strategic input to support clinical operations and regulatory submissions across a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Finance and Operations dept. brings insights and intelligence to inform decision making & drives digitalization and business solutions to ... attain NNI goals. Finance and Operations works closely across the organization to guide enterprise-wide...to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Identity key milestones at Study, Country, and Site Level to gauge clinical trial performance. Build and Maintain Metrics Catalog, Dashboards Catalog along with ... / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption...Minimum 7 years' experience in life sciences, pharma with Clinical Trials Operational Data, Clinical Operational Metrics… more
- Merck & Co. (North Wales, PA)
- …and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... to 50% travel required with some overnight.Role Summary The Regional Medical Scientific Director - GI Oncology is a credentialed (ie, PhD, PharmD, DNP, MD)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in the West, in ... adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities:Study… more
- Merck & Co. (Rahway, NJ)
- …The Equipment Development and Facility Engineering (EDFE) Leader position will report to the Director , Engineering and will be a member of the EF Team at the Rahway ... the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team member supporting… more
