• Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …on clinical programs in scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and ... centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management... Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered… more
    HireLifeScience (03/11/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... advanced degree is preferred A minimum of 12 years' progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO and/or… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input… more
    HireLifeScience (03/21/24)
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  • Merck & Co. (North Wales, PA)
    …including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical ... /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer on … more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …& Development. Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs and ... including NNI Evidence Generation Plans and Product Development Plans Clinical study management : Provide regional medical &...expert medical community input Regulatory liaison: Write and/or review clinical sections of clinical trial more
    HireLifeScience (03/15/24)
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  • Merck & Co. (Rahway, NJ)
    … supply packaging and distribution operationsExperience with clinical trial operationsFamiliarity with SAP Operations Management Certification (ie, APICS ... Job DescriptionThe Associate Director , Clinical Supply Operations (CSO) within...CSO workstreams to support the business.Collaborating closely with Global Clinical Trial Operations (GCTO) and Regulatory teams… more
    HireLifeScience (03/15/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external… more
    HireLifeScience (03/07/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …is preferred Requires a minimum of 10 years of progressively responsible clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders… more
    HireLifeScience (03/28/24)
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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 ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical more
    HireLifeScience (03/09/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... ready to make a difference? The Position We are seeking a Senior Director , Global Regulatory Portfolio Lead who will be responsible for developing, implementing, and… more
    HireLifeScience (03/29/24)
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  • Merck & Co. (Rahway, NJ)
    …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
    HireLifeScience (03/26/24)
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  • Novo Nordisk Inc. (Chicago, IL)
    …in a timely fashion. In addition, the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to the field team, and ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...training initiatives for the medical affairs team Serve on Clinical Trial Strategy Team to identify investigators/sites… more
    HireLifeScience (03/20/24)
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  • Merck & Co. (Rahway, NJ)
    …execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring ... clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle. Qualifications: Successful candidates will be able to ... immune disorders. Summary Position manages the end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other… more
    HireLifeScience (03/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …to perform technical and strategic assessment of new and innovative biomarker platforms for clinical trial , and to support for clinical and non- clinical ... as well as with other functions such as Clinical Development, Clinical Operations, Biostatistical and Data Management members to ensure timely deployment… more
    HireLifeScience (03/22/24)
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  • Eisai, Inc (NJ)
    … provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
    HireLifeScience (02/14/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …and applicable ICH guidelines is strongly desired.Experience in drug development, clinical trial methodology. Rare disease experience preferred.Experience in ... New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical...be responsible globally for executing the safety and risk management activities for one or more clinical more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … and Clinical Development. Responsibilities Creates and oversees process for clinical trial sample testing activities and data capture to support CDx ... regulatory submission or associated drug regulatory submissions.Responsible for implementation of clinical trial assays at Diagnostics Partners, reference labs… more
    HireLifeScience (03/02/24)
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  • Merck & Co. (Rahway, NJ)
    …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… more
    HireLifeScience (03/05/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
    HireLifeScience (03/01/24)
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