- Novo Nordisk Inc. (Plainsboro, NJ)
- …Responsible for overseeing and managing various aspects of operational activities within Clinical Development & Operations (CDO). Takes ownership to deliver upon ... and optimization of organizational resource allocation. Relationships Reports into Clinical Development & Operations (CDO) Director/Associate Director. Establish… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical ... if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP and aligned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will ... interface with key stakeholders across Novo Nordisk Inc (NNI) including Clinical Development , Medical, & Regulatory Affairs (CMR), Commercial Strategy &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director- Clinical Research & Development . Internal relationships include working with ... and project strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical &… more
- Merck & Co. (Rahway, NJ)
- …new or marketed Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage ... the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Specifically, the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and ... and Product Development Team (PDT) lead, Oncology Global Clinical Development , has primary responsibility for the planning and directing clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with ... critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study Strategy: Drafts development plan… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and balancing… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... both internal and external to GCS and serve s as the GCS spokesperson at clinical development related meetings (i .e., Clinical Trial Team s ) and product … more
- Aequor (South San Francisco, CA)
- …biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas Accountable for the development ... types of biomarker samples and specifications for collection and lifecycle Extensive clinical development experience of working in teams running clinical… more
- Formation Bio (New York, NY)
- …cross-functional teams to achieve the strategic objectives of the clinical development programs.ResponsibilitiesLeadership and Strategy: Develop and implement ... drivers. Facilitate effective communication and collaboration between internal teams, such as Clinical Development , Clinical Data Management, and Site… more
- Genmab (Plainsboro, NJ)
- …entire spectrum of drug development at Genmab, from Discovery to Late Clinical Development and beyond.The Head of Clinical Pharmacology & Quantitative ... the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology strategies for Genmab's … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH,… more
- Genmab (Plainsboro, NJ)
- …within the field of oncology is preferredMinimum 2 years' experience as Clinical Operations representative in Clinical Development Teams (CDTs) ... and CTAs across trials within a program, ensuring performance and competency development .Collaborate with Global Clinical Trial Managers (GCTMs) on trial… 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 (Plainsboro, NJ)
- …will be responsible for oversight of a program of global studies, covering all clinical development deliverables.The role is hybrid and can be filled either in ... of the Compound Development Team (CDT) representing Development Operations.Provide input into the Clinical and...(CDT) representing Development Operations.Provide input into the Clinical and Compound Development Plans developed by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... industry, regulatory agency or academia, with exposure to drug development , clinical pharmacology, and/or epidemiology required.Must have expertise… more
- Genmab (Plainsboro, NJ)
- …drug supply strategic planning and execution, and maintain information on changing clinical development planIdentify risks for delays for projects/programs and ... compliance during all drug supply planning tasks, activities, and deliverablesGlobal Clinical Drug Supply:Support development and maintenance of SOPs for… more
- Merck & Co. (North Wales, PA)
- …clinical trial objectivesCore Skills:Pharmaceutical, research, medical, and/or clinical drug development knowledge/experienceStrong communication, writing, ... process improvement, data analyticsEducation/Experience:Bachelor's Degree +1 years of pharmaceutical, clinical drug development , project management, and/or medical… more
- Mammotome (Miami, FL)
- …the stereotactic, ultrasound and MRI environments.Assist with Sales Representatives' clinical development through corporate training events.Deliver product ... with diagnostic tools that address the world's biggest health challenges.The Clinical Applications Specialist for Mammotome is responsible for providing customer… more
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