- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated ... regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.Oncology expertise requiredClinical safety … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with minimal direction from group head and provide statistical scientific leadership for clinical trial safety data. Lead the statistical support for safety ... Safety analysis methodology and standardization, develop and support statistical safety analysis methodology and standardization across the clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacovigilance Procedures (GVP) required4 or More Years Knowledge of FDA regulations, clinical and safety databases; preferred4 or More Years Familiarity with ... Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance Must have ... GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials. Ability to provide interpretation and guidance for internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases, preferredFamiliarity with Good ... PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; preferredExtensive… more
- Eisai, Inc (Pittsburgh, PA)
- …decision-makers through understanding of issues and opportunities in territory. Deliver clinical , efficacy, and safety messaging and information about product ... Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with… more
- Daiichi Sankyo, Inc. (Denver, CO)
- …research areas centered around rare diseases and immune disorders. Summary: The Oncology Clinical Educator role provides disease state, REMS, and product safety ... work within a specified region to enhance disease, REMS, and product safety knowledge, coordinate and provide staff training, and enhance proper administration. The… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
- Merck & Co. (Upper Gwynedd, PA)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... --The Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior Director has… more
- Merck & Co. (Rahway, NJ)
- …and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and respiratory… more
- Merck & Co. (Boston, MA)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company's… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance ... compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical… more
- Merck & Co. (North Wales, PA)
- …of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
- Merck & Co. (North Wales, PA)
- …of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.-The position is ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Formation Bio (New York, NY)
- …role, you'll pioneer the development of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Merck & Co. (North Wales, PA)
- …and maintain statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.Act as a ... statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.Develop and execute statistical analysis and reporting… more
- Merck & Co. (Rahway, NJ)
- …experience in CDISC SDTM and ADaM standards.Must possess programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic data (raw ... Engineering or related field plus 3 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied… more
- Merck & Co. (Rahway, NJ)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the… more
- Merck & Co. (Rahway, NJ)
- …The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation ... connection and collaboration within and across teams and functions.-The NGB GMP clinical manufacturing building will be a new entirely single-use facility, and this… more
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