- Merck & Co. (Rahway, NJ)
- …design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: ... expert opinion on scientific questions relevant to his/her areas of responsibility. The Senior Director is responsible for maintaining a strong scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... of external vendors within technical scope. Will also be responsible for the internalization and oversight of the RBQM...Indicators, and grouped variables for signal detection. Articulate to Study Team for appropriate site and study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …FIH, clin pharm patient studies , and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from ... Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for..., Clinical Operations on plans for successful implementation of studies . Responsible for management of compounds at… more
- Merck & Co. (Rahway, NJ)
- …external opportunities.Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projectsThe Executive Director ... and will interact externally with key opinion leaders.-Specifically, the Executive Director may be responsible for:Evaluating pre-clinical and translational work… more
- Merck & Co. (Rahway, NJ)
- …Affairs and Clinical Safety (GRACS) and external to GRACS.Key functions:Reports to Senior Principal Scientist ( Senior Director ) and/or Distinguished ... Director / Principal Scientist, Regulatory Affairs Liaison , is responsible for the development and implementation of worldwide regulatory strategy for… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global regulatory ... to ensure effective achievement of regulatory/business objectives. The Executive Director will direct the development and submission of investigational drug… more
- Merck & Co. (Rahway, NJ)
- …and ensures proper allocation of drug product as needed across studies within assigned program(s).- Responsible for identifying significant supply risks ... plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have demonstrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and driving the methodology, approach, and best practices… more
- Merck (Rahway, NJ)
- …design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director May Be Responsible For:** + ... drugs + Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as...scientific questions relevant to his/her areas of responsibility. **The Senior Director is responsible for… more
- Actalent (Basking Ridge, NJ)
- Job Title: Senior Clinical Study Manager The Senior Clinical Study Manager is responsible for ensuring the successful execution and delivery of ... clinical studies . Responsibilities + Lead the development of clinical study plans, identifying critical path activities and interdependencies. + Create and… more
