- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Job DescriptionDirector, Clinical Research ScientistServe as a key role in contributing to the scientific and ... expertise in a therapeutic area leading one or more clinical trials for one or more compounds in various...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Formation Bio (New York, NY)
- …house clinical trial execution strategy and outsourcing to a Contract Research Organization (CRO) when needed. Support the selection, contracting, and ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...performance of Contract Research Organizations (CROs) and other external vendors when… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, ... and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a...in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Programming Manager, Clinical Programming is responsible for ensuring integrity, consistency and adherence to Study ... This role reports to the Director, Team Lead of Clinical Programming.Responsibilities/tasks - including but not limited to:Implements and...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Job Summary: Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate ... Manager within Clinical Operations, in adherence to the protocol, Good ...a medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience preferredTime spent directly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SAs) or Senior SAs who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), appropriate ... guidelines. The SA Manager will ensure the SAs provide clinical administrative support to the study teams and support...to the study teams and support interactions with the Contract Research Organizations (CROs) and other vendors conducting the… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Genmab (NJ)
- …us!The Role:The Senior Statistical Manager acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners in… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Genmab (NJ)
- …us!The Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Merck & Co. (Flagstaff, AZ)
- Job DescriptionThe-Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education and ... operational and financial needs such as reimbursement information and contract adherence in an effort to help the provider...engage customers in quarterly business reviews regarding their vaccine contract to educate customers on the best ways to… more
- Genmab (NJ)
- …functions including Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology,Translational Research, Medical Writing, Project management, and ... database standards. Supports specification and pooling of data across clinical trials within the same project. Supports submissions by...in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems/capabilities with the R&D functional area, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug ... as the lead for the operational aspects of the Clinical Trials Management System. Provides leadership and manages CTMS...will be responsible for people management of employees and contract staff and for providing direction of daily activities… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... strategies. Experience with safety data collection and interpretation originating from clinical trials and other sources. Strategic Oversight Provides effective and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... Product Manufacturing, Program Management, CMC Regulatory, Manufacturing Operations, and Contract Manufacturing Organizations. This role is based in Boulder, CO.… more
- Merck & Co. (Rahway, NJ)
- …processing. -Technical ScopeParticipates in teams focusing on late stage clinical process development, characterization, and technology transfer and validation with ... reviews, authoring regulatory BLA sections and/or working with external contract organization for development and or manufacturing.Working knowledge of statistical… more
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