- Eisai, Inc (Nutley, NJ)
- …May provide training on GCP and current regulations for those undertaking clinical studies .Job SummaryThe Associate Director , GCP Quality Assurance ... conduct Clinical Investigator Site Audits, Vendor Audits, GCP Document Audits ( Clinical Study Reports and Trial Master Files), internal Process Audits and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management, and provide safety leadership including but not limited to clinical studies , post-marketing surveillance, signal detection and management, important ... research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product...the Global Product Team or specific sub-teams such as clinical study team and submission team, providing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or across several studies and resolve or ... clin pharm patient studies , and Phases 1-3 clinical trials at the study and program...multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , … more
- Cepheid (Miami, FL)
- …and Europe. This role also provides clinical compliance support for pre-market clinical studies .This position is part of the Clinical Affairs ... a patient waiting.Learn about the Danaher Business System which makes everything possible.The Director , Clinical Quality and Compliance reporting to the Sr … more
- Merck & Co. (Rahway, NJ)
- …The Senior Director will manage the entire cycle of late-stage clinical development and studies , including development strategy, study design, ... safety and efficacy as well as new drug applications, clinical study reports, or publicationParticipation in internal...of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external stakeholdersProvides ... rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development,...CDLContributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables,… more
- Merck & Co. (Rahway, NJ)
- …operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...ensures proper allocation of drug product as needed across studies within assigned program(s).-Responsible for identifying significant supply risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the… more
- Merck & Co. (Boston, MA)
- …decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publicationsParticipating in internal and joint ... may supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate ... and external stakeholders. Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management) may also be required.… more
- Merck & Co. (Upper Gwynedd, PA)
- …The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, ... and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Genmab (NJ)
- …and consistency across programs and systems. This role reports to the Director , Team Lead of Clinical Programming.Responsibilities/tasks - including but not ... fit? Then we would love to have you join us!The Programming Manager, Clinical Programming is responsible for ensuring integrity, consistency and adherence to … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reporting requirements that adhere to programming standards and specifications across clinical studies . This position involves managing direct reports and/or ... and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings,...ensure complete, high-quality data is available for use by clinical study teams in a timely manner.… more
- Merck & Co. (Upper Gwynedd, PA)
- …and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case ... SummaryUnder the guidance of a senior leader, a Principal Scientist/ Director , has primary responsibility for developing value evidence strategies, and… more
- Merck & Co. (North Wales, PA)
- …and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case ... the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... rare diseases and immune disorders. Job Summary: Position leads complex studies in study design, statistical analysis and interpretation of results with some… more
- Eisai, Inc (Nutley, NJ)
- …manager teams on strategic designs of studies ; develops, reviews and/or approves study documents such as clinical study protocols, statistical analysis ... we want to hear from you.This position serves a critical role within the clinical development in that he/she will be responsible for designing clinical trial,… more
- Eisai, Inc (Exton, PA)
- …supply of DS/ADI for pre- clinical and phase I to phase III clinical studies , including the development of long-range planning and weekly production ... If this is your profile, we want to hear from you.The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building… more
- Merck & Co. (Rahway, NJ)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and… more
- Genmab (NJ)
- …strong knowledge about the feasibility and allocation process of a program and/or study .Must understand the Clinical Trial matrixed process from research through ... and development of data-driven early indication and program assessments, study -level feasibility assessments, robust country and site identification, support of… more
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