- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations ... 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...years of relevant experience. required Experience Qualifications Experience in clinical operations methods and processes in industry… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Director , Global Clinical Trial Operations (GCTO) Project Management Office (REMOTE) The core responsibility of this ... are updated and readily available for internal teams and senior leaders. Upon completion of a project, the PMO...pharmaceutical industry with the majority of time spent in clinical operations .- Proven ability to analyze, integrate,… 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 ... (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Vice President, Medical & Science. Work with the VP Medical/Scientific Development, Clinical Operations , Non- Clinical Research, Medical Writing, Program ... and international regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations , Non- Clinical Research, Medical Writing,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) ... Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will also serve as the Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... About the Department The Finance and Operations dept. brings insights and intelligence to inform...to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director will work closely with cross-functional project teams, including Clinical Development, Clinical Operations , Biometrics, and Regulatory Affairs ... Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director...Writing team. Essential Functions Provides strategic input to support clinical operations and regulatory submissions across a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …PV Operations ' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… 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)
- … Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... budgets and resources for the assigned GMA plan activities, in collaboration with Sr Director .Support medical readiness activities for market launches and life… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), ... for the assigned GMA plan activities, in collaboration with Sr Director .- Leads medical readiness activities 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)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and ... between studies in one or several programs.- Partner and collaborate with Clinical Operations , Biostatistics and Data Management, Regulatory Affairs and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations , Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's ... communicates internal compliance metrics within Daiichi Sankyo.Member of Global Clinical Trial Disclosure Function and Operations Committee.Act as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, US East Coast ... Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs, Data Management, Biostatistics, Non- clinical ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in support of these objectives. This position will report to the Sr . Director , Management Office & Business Excellence in CSPV.ResponsibilitiesProject ... the Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and ... milestones in launch planningMedical leadership input for cross functional partners including clinical , operations , HEOR and commercial to ensure that there is… more
- Insmed Incorporated (Bridgewater, NJ)
- …programs and projects.Proactively identify areas of opportunity across the training teamWork with Director and Sr . Director to assess and analyze the ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development, will be a key member of the… more
