- Genmab (NJ)
- …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… 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)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight ... and authentic is essential to fulfilling our purpose.The Role:An Associate Director , Data Management is operationally responsible...portfolio. The employee will also provide input to Genmab clinical drug development programs to ensure data… more
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late-stage development , the Executive Clinical Director will manage the ... the development of new compounds The Executive Clinical Director may: Oversee the clinical...in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects Assist the Associate… more
- Genmab (Plainsboro, NJ)
- …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...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core...MBA, Ph.D., PharmD) preferred - Experience and knowledge of clinical drug development strongly preferred; including the… 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 provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… 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 ... the relationships with the clinical vendors as well as coordinate and manage outsourcing of new trials. The role will include responsibilities in - and is not… 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 will ... making and increase commercial rigor through all phases of alliance asset development .Reporting to the Director of Global Commercial Pipeline Analytics, the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...with cross-functional teams, including members of the CDSE team, clinical development , medical affairs, regulatory, and commercial,… 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
- Genmab (Plainsboro, NJ)
- …our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and maintenance ... Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be...and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, preferably… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Merck & Co. (Rahway, NJ)
- …control and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ... Working Groups to ensure full integration of the device development activities with the clinical , regulatory, formulation,...of the device development activities with the clinical , regulatory, formulation, commercial and other key of our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Merck & Co. (Rahway, NJ)
- …driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will report ... development with exposure to all stages and aspects of development (pre- clinical , clinical , and commercial)Strong influencing and communication… more
