- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated project/product risk management ... a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Merck & Co. (Rahway, NJ)
- …support and influence clinical and commercial combination product development and launches.Principal Responsibilities: Lead and set direction for the ... with applicable regulatory, quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device… more
- Merck & Co. (Rahway, NJ)
- …clinical drug development , GCP and ICH guidelines, and the clinical regulatory environmentDemonstrated ability to influence senior level stakeholders and ... clinical organization within Translational Medicine (TMed) is responsible for early clinical development of novel therapeutics, working in close collaboration… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of ... a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director, Global Clinical Operations on plans for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead ).-Where ... with different levels of study governance, as required-Oversee the development of the clinical study plan including...The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the… more
- Merck & Co. (Rahway, NJ)
- …organizations (as a lead GCS Planning program representative) such as clinical development , regulatory, quality and other supply chain areas to negotiate ... external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the Program CSPM designs… more
- Merck & Co. (Rahway, NJ)
- …assurance, analytical laboratories, manufacturing, production support area, clinical development .-Strong leadership skills with the ability to lead teams ... shift.-Required Skills: Accountability, Accountability, Adaptability, Audits Compliance, Biochemistry, Chemistry, Clinical Development , Communication, Data Analysis, Detail-Oriented, Deviation… more
- Merck & Co. (Rahway, NJ)
- …and provides biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, ... disease area. Primary activities :Serves as statistical representative and lead in the cross-functional teams for the strategic planning... project as neededLead biostatistics in early or late clinical development planning to ensure that study… more
- Formation Bio (New York, NY)
- …an experienced and forward-thinking Senior Director of Toxicology to join our Development team. In this role, you will lead our toxicology efforts, ... will be a key member of the Formation Bio Development team.About the Role Build and lead ...and oversee the execution of toxicology studies to support clinical development and regulatory submissions Contribute toxicology… more
- Merck & Co. (Rahway, NJ)
- …our Company communications teams. Key Responsibilities Product Strategy & Roadmap Lead and manage IT applications supporting corporate communications, serving as the ... priorities as new insights and data emerge. Discovery & User Research Lead ongoing discovery activities (user research, interviews, surveys, usability testing) in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... Cycle Management. Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA strategy and medical objectives for the assigned… more
- Merck & Co. (Rahway, NJ)
- …and OT/IT systems that enable formulation, filling, and support activities for clinical and development sterile products. This position supports start-up ... Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality...& Experimentation) center, with a primary focus on sterile clinical manufacturing within Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionFrom its roots as a clinical development company, Formation Bio is harnessing the power of deep ... learning and artificial intelligence to break clinical development paradigms and transform how drugs...Why Join Us? Impact: Shape IP strategy as our senior legal leader for a portfolio of clinical… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or… more
- Terumo Medical Corporation (Somerset, NJ)
- …**_Advancing healthcare with heart_** **Job Details/Responsibilities** 1. Strategic Planning and Execution: Lead the development and implementation of short- and ... Senior VP, Sales & Marketing - TIS Date:...practices and Design Control when participating in new product development and clinical activities. Fully adhere to… more
- Formation Bio (New York, NY)
- …scalable curation workflows. Data Modeling, Ontology-Driven Harmonization & Unstructured Integration Lead development of robust SQL/dbt models that unify complex ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners,...the roleWe are looking for a driven and organized senior accountant who is excited to join a fast-paced… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... affairs projects within a specific compound or indication.Responsibilities- Support GMA the development of the Global Medical Affairs strategy and execution of the… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging Discovery Research through Late-Stage Clinical Development . The Therapeutic Area (TA) Lead will provide strategic oversight ... direction of clinical programs involving translational research and early clinical development for the Neuroscience Therapeutic Area. They are expected… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross functionally with multiple functions and groups throughout the US organization, Clinical Development , Research & Early Development , other affiliates, ... Prioritizes phasing of objectives based on engagement objectives and sales forecasts. Lead the development and execution of annual and long-term brand… more
