- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Genmab (NJ)
- …(including clinical trial implementation, and oversight of all aspects of clinical development) working closely with the Medical Director and other ... of the clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers… more
- Merck & Co. (Rahway, NJ)
- …operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have ... Job DescriptionThe Global Clinical Supply organization is accountable for managing the...ensures proper allocation of drug product as needed across studies within assigned program(s).-Responsible for identifying significant supply risks… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...implement, and maintain detailed, integrated trial timelines from the study outline through CSRDevelop initial recruitment projections and strategyApprove… more
- Merck & Co. (Rahway, NJ)
- …the way we approach serious diseases. --The Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance ... Director will manage the entire cycle of clinical development, including study design, placement, monitoring,...of Clinical Scientists in the execution of clinical studies . --Work closely with a cross-functional… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionTitle: Associate Principal Scientist/ Associate Director , Outcomes ResearchRole SummaryUnder the guidance of a senior leader, an Associate ... and programsIn collaboration with internal teams and external partners, designs studies , authors study protocols, develops measurement questionnaires, case… 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
- Merck & Co. (Rahway, NJ)
- …and others.To prepare outcomes research protocols, statistical analysis plans, and clinical study reports.To ensure findings are communicated effectively at ... objectives To inform and contribute to the value evidence plan and associated studies which demonstrate clinical , economic, and patient-centered value. The work… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and ... researchIdentifies barriers to patient enrollment and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations… more
