- Merck & Co. (North Wales, PA)
- …is to lead the coordination and execution of major change projects across Global Clinical Trial Operations. The role will also assist with Program Management ... are updated and readily available for internal teams and senior leaders. Upon completion of a project, the PMO...degree with at least nine (9) years of pharmaceutical, clinical drug development, project management and/or medical field experience.… more
- Merck & Co. (Rahway, NJ)
- …the guidance of the Clinical Development Finance Associate Director , the Finance Senior Specialist will:Provide financial planning, forecasting ... with stakeholders including the Global Project Manager, Global Trial Manager, Clinical Sub Team, Clinical Trial Team and Outsourced Trial Team for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. ... scope/portfolio.Close collaboration with Asset and Portfolio Management (APM), GCO Clinical Trial Business Operations (CTBO), and GCO...in role such as a Global Project Leader at Sr . Director level or equivalent preferred- Relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Planning and Execution: Provides input on major milestones of trial , clinical trial plan and...CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL… more
- Merck & Co. (Rahway, NJ)
- …in meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs ... Involved in research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration and role consistency. Accountability for quality and performance related managing clinical trial sites (ie data quality, document handling, and ... added plus Expert in ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources… more
- Merck & Co. (North Wales, PA)
- …Job Responsibilities Responsible for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team ... (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management… more
- Merck & Co. (Rahway, NJ)
- …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… more
- Eisai, Inc (Nutley, NJ)
- …plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be...update plans and inform stakeholders of progress. 30%Phase IV clinical studies: Direct and design strategies, planning and implementation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders.SummarySenior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety...for such candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …business, and other functional groups across NN. External relationships can include clinical trial sites and external vendors. Essential Functions Develop and ... quality concerns. Relationships This position reports to the Associate Director of GXP Oversight and/or Head of GXP Support....or resolve, for example across various topics, such as clinical trial management, deviation handling, and product… more
- Merck & Co. (Rahway, NJ)
- …leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in ... Job Description Position Description: Director , Business Development - Enabling Technologies Search and...conjunction with functional and clinical development leadership. Responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …access strategy for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible ... around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both...its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of … more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Eisai, Inc (NJ)
- … provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study findings through presentations and/or publications in peer-reviewed scientific journalsAssess clinical trial and/or other data sources to contextualize ... centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, and analytic support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
- Novo Nordisk Inc. (Chicago, IL)
- …coordination with his/er Field Director . Relationships Position reports to Field Director / Sr Field Director . Serves as organization spokesperson on ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...to make a difference? Open to hiring at the senior level commensurate with experience. The Position Builds relationships… more
