- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... of a single or multiple clinical trials from strategy outline through to CSR by...outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical … more
- Merck & Co. (Rahway, NJ)
- …by leveraging digital, data, and analytics to measure our organizational impact.The Associate Director , Global Oncology Commercial Pipeline Analytics, HHDDA ... Job DescriptionAssociate Director , Global Oncology Commercial Pipeline Analytics,...global marketing, operations, finance & enterprise strategy, and clinical & discovery to inform executive decision making and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Insmed Incorporated (New York, NY)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug ... - The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...& Development pipeline and realize its full potential. The Associate Director is expected to provide project… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and ... Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be...global regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead...These business functions include but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, facilitate… more
- Merck & Co. (Rahway, NJ)
- …risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead ... to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key of our company's functions.Lead… more
- Genmab (Plainsboro, NJ)
- …and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert...Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Merck & Co. (Rahway, NJ)
- …and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global ...skills Preferred Experience and Skills: At least 5 years global or US medical affairs or clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Merck & Co. (Rahway, NJ)
- …Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and ... /PDT lead may:-Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.-Supervise the activities of entire … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... impact analysis, supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and… more