- Merck (Honolulu, HI)
- …and oversight for programs identified as critical to the success of Global Clinical Trial Operations (GCTO), Global Clinical Development (GCD) objectives ... program. The incumbent should also provide operational leadership and guidance to Global Clinical Trial Operations (GCTO), Global Clinical Development (GCD),… more
- Merck (Honolulu, HI)
- …The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed ... Risk Assessment and Categorization Tools and Quality Plans in partnership with the Clinical Trial Team (CTT). + Collectively and periodically (eg quarterly)… more
- Merck (Honolulu, HI)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Takeda Pharmaceuticals (Honolulu, HI)
- …of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, ... at a study level. + Develop strong analytical competencies including the use of clinical data sets to facilitate trial planning, forecasting, and modeling. + Act… more
- Takeda Pharmaceuticals (Honolulu, HI)
- …of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, ... research setting at a sponsor or CRO. + 6+ years of experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization with evidence… more
- J&J Family of Companies (Honolulu, HI)
- …experience in quality, regulatory, post market surveillance, post market quality, adverse event reporting, clinical trial design, or clinical trial . * ... this position is Raritan, NJ or Irvine, CA however remote options within the United States will be considered...promotion. Specifically, the Manager will lead the execution of Clinical Evaluations and Summaries of Safety and Clinical… more
- J&J Family of Companies (Honolulu, HI)
- …at least 8 years of applicable biomarker, translational research, program management, clinical trial and/or research experience is required **Required Years of ... located in Spring House, PA; Boston, MA; Raritan, NJ; Brisbane, CA or Remote (considered on a case-by-case basis). At the Janssen Pharmaceutical Companies of Johnson… more