- 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
- 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)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials.- Global Clinical Supply is accountable for the planning, sourcing, labeling, packaging and delivery of … 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
- Merck & Co. (Rahway, NJ)
- …the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance ... Job DescriptionOur company is a global health care leader with a diversified portfolio...medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage… 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... forward momentum, and an inspiring mission to achieve new milestones in global healthcare. The Biologics and Biopharmaceutics team is responsible for the research… 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
- 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)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be ... a part of our Global Regulatory Affairs organization.In this role, you will work...Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as ... About the Department Our East Coast Global Development Hub brings together the best minds...NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating… 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
- 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)
- …new 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 ... internal project team(s) and team leader(s) or US based Global Function leaders as a Finance Business Partner.Provides guidance...and is accountable for the development and control of Clinical Project Budget in support of Phase I-III … 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess...study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within the Global … 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