- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...biotechnology experience in one or more key functions (eg clinical operations , clinical research, … 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
- 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
- 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
- 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)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, ... Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations , Medical Affairs and labelling.-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research 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...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. ... 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… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for...relevant experience is required with a BSc required.Experience in clinical operations methods and processes in industry… 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… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be a key ... to understand training needs and translate into actionable and enriching associate learning curricula and fostering connections among commercial associates. This… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing,… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations , non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... processes (ie automation, technology, process optimization). Relationships Reports to Director or above within CMR Training & Knowledge Management. Collaborates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improvements and seeks agreement through consensus management. Relationships Reports to an Associate Director / Director within the NNI Procurement ... Research, Data & Analytics, Logistics & Distribution, Patient Support Solutions, Clinical Operations Pharmaceutical industry experience helpful, but not required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at...a pharmaceutical, biotechnology, or CRO required. Training & Development, Operations and/or Learning and Development experience preferred A minimum… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a ... clinical studies and experience multiple facets of Clinical Operations in a dynamic, supportive, collaborative...and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …include ensuring compliance with international trade regulations and optimizing supply chain operations . The Associate Director , CSCL Customs & Trade ... S ummary** This position will play a crucial role in managing the import and export operations for Clinical Supply Chain Logistics (CSCL). Responsibilities… more
