- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and ... regulatory agency or academia, with exposure to drug development, clinical pharmacology, and/or epidemiology.Oncology expertise requiredClinical safety … more
- Merck & Co. (Upper Gwynedd, PA)
- …medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,...of marketed compounds. In executing these duties, the Senior Director may: Supervise the activities of Clinical … more
- Merck & Co. (Boston, MA)
- …Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of ... 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. (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… 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)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director … 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
- Genmab (NJ)
- …us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best… more
- Merck & Co. (Durham, NC)
- …is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and ... products including Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate… 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
- Genmab (NJ)
- …have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …drug coding conventions (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases, preferredFamiliarity with Good ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Merck & Co. (Rahway, NJ)
- …clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study ... and will interact externally with key opinion leaders. Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and translational work… more
- Merck & Co. (Rahway, NJ)
- …and respiratory medicines. With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including ... execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and… more
- Merck & Co. (Rahway, NJ)
- …Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure).The Senior Director will manage the entire cycle of ... monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and translational… more
- Daiichi Sankyo, Inc. (Denver, CO)
- …and is comprised of nurses working under the general direction of the Regional Director of Clinical Nurse Managers. The OCE is responsible for educating ... plans to meet targeted customer needs.Monitor, collect, and communicate to the Director , Clinical Nurse Manager on customer insights regarding their need… 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
- Merck & Co. (Rahway, NJ)
- …Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the ... scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current...and academic or industrial partners.- In partnership with the Director of Chemicial Engineering R&D and/or the Head of… more
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