- 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
- 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...and to create value for patients and the healthcare system .Responsible for maintaining high level of visibility of operational… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Deliver the development and implementation of Research & Development (R&D) informatics systems and programs to support the business functions of Daiichi Sankyo (DS)… 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
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...with our Company IT leadership to develop a long-term systems and capability strategy and to prioritize DSCS Digital… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... time throughout the annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs. Has direct supervisory responsibility… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support and ... status. In addition, this role will support the FxExc Director in lead innovation and optimization by gathering industry...including experience in one or more key functions (eg, clinical research, clinical operations , data… more
- Merck & Co. (Rahway, NJ)
- …capital and non-capital improvement projects, and interfacing with the automation system assets spanning production, utility systems and associated ... a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering position will report to the Director ,… more
- Merck & Co. (Rahway, NJ)
- …and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives. -Under the guidance of ... the Regional Director , Clinical Quality Management (RCQM), and in...(s), the Sr CCQM Lead establishes and/or - local clinical Quality Management System (CCQMs) aiming to… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... include the-development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify,… more
- Merck & Co. (Rahway, NJ)
- …collaboration (including the CTC Clinical Trial Coordinator, CRAs and-COM Clinical Operations Manager).-Responsible for creating and executing a local risk ... Point of Contact (POC) for assigned protocols and link between Country Operations -and clinical trial team (CTT).Responsible for project management of the… more
- Merck & Co. (Rahway, NJ)
- …overall success of the pilot plant. The Facility Lead position reports to the Director of Operations /Head of SSO Pilot Plant and the successful candidate will ... and lead. Track-record of independent problem-solving. Preferred Experience and Skills: Operations experience in a GMP clinical supply facility (intermediate… more
- Merck & Co. (Rahway, NJ)
- …role of Associate Director . The team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems… more
- Merck & Co. (Rahway, NJ)
- …work to design, install, and qualify new equipment to support GMP clinical production. -Execute and develop appropriate system validation, change control, ... on automation within Biologics Process Research & Development (BPR&D).The Associate Director role-will provide process automation leadership within the BDC Pilot… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …privacy, legal, compliance, IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data ... and their importance / relevance to key constituents, information stewards, system owners, stakeholders, and data users.- Collaborate with an extensive cross… more
- Merck & Co. (Rahway, NJ)
- …execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure.- ... responsibility. The Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the… more
- J&J Family of Companies (Raritan, NJ)
- Director Clinical Operations DPS -.../ participates in the selection and implementation of new systems and tools for clinical operations . ... more information, visit www.depuysynthes.com. We are currently seeking a ** Director - Clinical Operations ** to...new methods, systems / tools in addressing clinical operations needs, and present the business… more
