- Daiichi Sankyo, Inc. (Philadelphia, PA)
- …executes geographical based strategic and tactical plans to meet targeted customer needs. Monitor , collect, and communicate to the Director, Clinical Nurse ... research areas centered around rare diseases and immune disorders. Summary: The Oncology Clinical Educator role provides disease state, REMS, and product safety … more
- Insmed Incorporated (San Diego, CA)
- … Clinical Development, you will support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor (s) for assigned protocols and/or ... clinical development and operations, regulatory, medical affairs, drug safety , and quality assurance teams, as well as overall...query resolution for the protocol and work with other clinical scientist(s), medical monitors, and drug safety … more
- Eisai, Inc (Nutley, NJ)
- …of the study from protocol concept to final report including interpretation of clinical data.Serves as Medical Monitor (where applicable) to review and ... monitor study data.Implements strategies to identify, monitor and resolve clinical program/trial issues.Interprets study data and develops integrated… more
- Formation Bio (New York, NY)
- … studies. As part of this responsibility you will provide strategic input to and monitor the execution of clinical studies as a project physician.Your ability to ... and clinical development plans Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... & Technical Operations or the Director, GxP Compliance, Patient Safety , & Vendor Oversight. This job will interact with...timely updates and compliance with internal and external requirements Monitor and track the lifecycle of GxP documents to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues internally, raising such for DS action per exception/defined criteria for escalation- Monitor clinical trial performance and quality metrics and share with ... Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the...Analytics, Reporting and Solutions (MARS) team to drive and monitor progress. The SDL fosters an environment where the… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- ….Participate in the development of target product profiles and preclinical safety packages to support clinical development and commercial strategy.Collaborate ... seeking Sr. Director of Toxicology as part of the Clinical Development team based in Philadelphia, PA or Somerset,...Director of Toxicology to lead and oversee all nonclinical safety assessment activities for our cell and gene therapy… more
- Eisai, Inc (Cincinnati, OH)
- …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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …components. Monitor inventory levels and implement best practices for safety stock and demand variability.Lead and perform future forecasting analysis that ... team, various Technical Operations and Quality functions to support both clinical and commercial manufacturing operations, in accordance with cGMP requirements, and… more
- The Cigna Group (St. Louis, MO)
- …and effects analyses (FMEA) to proactively identify and mitigate risks. + Establish and monitor clinical safety KPIs, including adverse event rates, sentinel ... implement continuous improvement methodologies like Six Sigma or Lean Healthcare. + ** Clinical Safety Oversight:** + Lead the development and implementation of… more
