- Merck & Co. (Rahway, NJ)
- … supply chain across the full of our company's Research Laboratories portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM)...at clinical development related meetings (i .e., Clinical Trial Team s ) and product… more
- Merck & Co. (Rahway, NJ)
- … supply chain across the full our Research & Development Division portfolio of clinical trial s .- GCS is accountable for the planning, sourcing, labeling, ... teams and the operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program...execution of all operational components of a large-scale global clinical program using strong clinical project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy:...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Strong understanding of market needs and resource allocation Strong expertise in clinical trial methodology and conduct, and GCP principles Superior ... within Novo Nordisk Inc. and Global HQ. Key internal relationships include Project Managers, Clinical Directors, Medical Affairs directors, HEOR Directors,… 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, acquires, or in-licenses drugs from… more
- Genmab (Plainsboro, NJ)
- …play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials . In addition, this position ... is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for CDO &… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... position is a key collaborator with statistics and other project stakeholders in ensuring that project plans...at least 5 years SAS programming experience in a clinical trial environment orMS in Computer Science,… more
- Merck & Co. (Rahway, NJ)
- … clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these ... development strategiesMonitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed Oncology drugs.Analyzing and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of...trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles,… more
- Merck & Co. (North Wales, PA)
- …statistical analysis and high-quality data to support decision making in clinical trials .Support statistical programming activities for late-stage drug/vaccine ... and efficacy analysis datasets, tables, listings, figures), which range from individual clinical trials to worldwide regulatory application submissions and post… more
- Merck & Co. (Rahway, NJ)
- …new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion… more
- Insmed Incorporated (San Diego, CA)
- …Responsible for appropriate review of all safety data from various sources (eg pre- clinical , clinical trial data, post-marketing, literature) throughout the ... and applicable ICH guidelines is strongly desired. Experience in drug development, clinical trial methodology; rare disease experience preferred. Experience in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial design, protocol development, and investigator selection in NN clinical trials For Phase IIIb and IV, drives trial design protocol development ... market oriented medical input and investigator selection in NN clinical trials Drive additional clinical ...workshops, Investigator Spon- sored Studies) Evaluation and decision of clinical trial proposals from Regions & Affiliates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trial design, protocol development, and investigator selection in NN clinical trials For Phase IIIb and IV, drives trial design protocol development ... market oriented medical input and investigator selection in NN clinical trials Drive additional clinical ...workshops, Investigator Spon- sored Studies) Evaluation and decision of clinical trial proposals from Regions & Affiliates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …conferences Communication: Works with the Global Medical Director(s) to transform the clinical trial data into scientific and commercial communication Works with ... recognition , understanding and value of current and future clinical compound(s)/profile(s) through data presentations Medical guidance & materials: Support… 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, acquires, or in-licenses drugs from… more
- Merck & Co. (North Wales, PA)
- …in alignment with Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO)Coordinates with Global Scientific Affairs to ensure ... Clinical Development, and IIS teamsAssists Country Medical Affairs senior leadership with field medical strategic planning and resource managementActively… more
