• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key… more
    HireLifeScience (03/11/24)
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  • Merck & Co. (North Wales, PA)
    …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical more
    HireLifeScience (03/21/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, and strategies Other essentials: Must ... in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working… more
    HireLifeScience (03/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … and stakeholder management and on-going maintenance of global program .Responsibilities:Accountable for building and establishing the clinical data review ... data review standards across early and late-stage asset trials in partnership with Clinical Development and Data Management . The Head of Data Review Excellence… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people ... implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy… more
    HireLifeScience (03/09/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to best support each program . This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are ... as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations… more
    HireLifeScience (03/01/24)
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  • Insmed Incorporated (San Diego, CA)
    …Workplaces for Millennials™ lists.OverviewThis Role is responsible for the overall leadership, management , and oversight of phase I-IV clinical trials from ... include, but not necessarily be limited to, the following: Provide leadership and management of clinical operations teamProvide leadership and management of… more
    HireLifeScience (03/12/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …highly strategic view is required. This opportunity will require a focus on all the clinical aspects of the upcoming HS program . Strong leadership skills are a ... amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Reports to Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop, design, and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...strategic learning expertise, learning performance consulting, and high-level learning program design for necessary cultural, leadership, management ,… more
    HireLifeScience (03/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external ... well as management of adverse events based upon approved Safety Management Team (SMT) materials.Supports overall program safety reporting (eg, Periodic… more
    HireLifeScience (03/07/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder Management : Build strong internal and external ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position Drive study management activities and manage cross-functional study team, external service… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
    HireLifeScience (03/28/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …research areas centered around rare diseases and immune disorders. Summary The Director of Clinical Bioanalysis has the responsibility of providing strategic ... bioanalytical leadership for all phases of clinical development for small molecule and biological therapeutic programs...oversight, for development and validation (as well as lifecycle management ) of PK, PD and immunogenicity assays to support… more
    HireLifeScience (01/08/24)
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  • Catalent (Harman, WV)
    …SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management , CAPA tracking, change control, risk management ,...substance and/or final drug product to support Phase I/II clinical trialsWork with clients during initial and subsequent manufacturing… more
    HireLifeScience (03/27/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
    HireLifeScience (03/27/24)
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  • Novo Nordisk Inc. (Chicago, IL)
    …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
    HireLifeScience (03/20/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …level for a larger number of projects/studies with greater complexity.Ensures data management deliverables for all studies within the project/ program level meets ... Data Management expertise to promote best practices across the Clinical Trial lifecycle. Qualifications: Successful candidates will be able to meet the… more
    HireLifeScience (03/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... partnering with the Global Team leader as the Project Management lead on drug development projects. This position can...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director more
    HireLifeScience (03/01/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as well as with other functions such as Clinical Development, Clinical Operations, Biostatistical and Data Management members to ensure timely deployment ... Leads to ensure the timely execution of biomarker tests on samples from clinical trials and to perform technical and strategic assessment of new and innovative… more
    HireLifeScience (03/22/24)
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