- 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
- 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
- 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)
- …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
- 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)
- …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)
- …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)
- …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
- Eisai, Inc (Nutley, NJ)
- …to the AD portfolio and continued support as a key partner to Clinical Development, Real World Evidence and Commercial Operations .The incumbent will provide ... If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's Disease, in the… more
- Eisai, Inc (Nutley, NJ)
- …unlawful actions.Oversee system data retention standards and verify system operations .Manage Eisai's information governance program, including JSOX ... Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the...System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), Certified Information Systems Auditor… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations . Essential Functions Work with ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... Requirements: A postgraduate degree such as Masters, MBA, PhD in Operations Research, Mathematics, Economics, Engineering, Biostatistics, MD, PharmD or a similar… 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)
- …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
- 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
- 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
- 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
