- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director /Senior Director , Clinical Quality Assurance. This is a hybrid ... commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership and… more
- Insmed Incorporated (San Diego, CA)
- …including monitoring of clinical studies , review & interpretation of clinical trial data, authoring clinical study and regulatory communications and ... for all issues identified which may affect the quality and integrity of clinical studies .Medical monitoring, coding, and data cleaning in collaboration with … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH...specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management...updates; Responsible for valid clinical interpretation of study results as Clinical Study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Development in Project Teams, possibly as Global Clinical Lead. Responsibilities: Study Strategy: Clinical study leader (CSL) or major scientific/medical ... studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management...updates; Responsible for valid clinical interpretation of study results as Clinical Study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in and ... PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies , literature, regulatory guidelines, and physiological/pharmacological...as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical… 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… more
- Merck & Co. (Rahway, NJ)
- …post-licensure). The Director will manage the entire cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory ... study of marketed compounds.In executing these duties, the Director may:Supervise the activities of Clinical Scientists...of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group… more
- Merck & Co. (Rahway, NJ)
- …post-licensure). The 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external ... of high-quality clinical trial protocols, review of clinical data and Clinical Study ...Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead… more
- Lee Health (Fort Myers, FL)
- …$50.50 - $68.19 / hour Summary HealthPark Medical Center is seeking an experienced clinical leader to fill their Nurse Director of Woman's Care Services. This ... incentives will be offered to the qualified candidate. The Director manages one or more defined areas of organized...He/she serves on the Nursing Leadership Council to provide clinical perspectives to issues, as well as, serves as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant working experience in externally sponsored research, including IIS and collaborative studies required4 or More Years in a clinical management setting ... areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs'… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external stakeholders- Provides ... with the CDL- Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external stakeholdersProvides ... collaboration with the CDLContributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures… 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 ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and ... contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines. Clinical regulatory documents include, but are not limited to, clinical study reports, investigator brochures, regulatory briefing documents, and ... contribute to strategic planning and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …indications.Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document ... other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the… more
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