- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for...indications required- Proven global line management expertise; experience of performance management and development of Director + level… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to ... Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under current guidelines,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and Delivery ... current in industry best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical Requirements Up to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio...resolve or escalate to appropriate Governance Committee. Analyze CRO performance trends within a clinical study or… more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department At Novo Nordisk, our Finance and Operations team is the engine that elevates holistic commercialization of our products. The Finance and ... Operations team works closely with the business across the...in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who ... input and guidance to other areas within NACD including Operations Director and TA Heads End to...Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …MSA discussions of external vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, Precision Medicine, etc.) ... employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other functional areas such as biostatistics, data management, clinical operations , pharmacovigilance, regulatory affairs, etc. Qualifications: Successful ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Director , QA Operations as part of the Quality team based in Raritan, NJ. ... Role Overview The Director of Quality Operations , CAR-T is...aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Knowledge of cGMP regulations… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... quality is maintained in all aspects of technical work as well as manage performance and ensure adequate training and support of staff. Some travel may be required… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... and stakeholder engagement.Engagement with MarketsDrive efforts to share strategies, plans and performance with a broad set of stakeholders to build alignment across… more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management, and our ... providing guidance to others in the statistical support for clinical drug/vaccine projects.-Interacts with Academic Research Organization (ARO), Contract Research… more
- Merck & Co. (North Wales, PA)
- …trial objectives.Liaises with partners, vendors, and vendor management team.Review and provide clinical operations input into relevant clinical documents ... of direct/indirect reports including assignment of resources, professional development, and performance management Core Skills Strong knowledge of clinical … more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …environment required and4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase ... as other research areas centered around rare diseases and immune disorders. SummaryThe Director of Oncology Imaging Science and Oversight will be a member of the… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... and motivation. Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Merck & Co. (Rahway, NJ)
- …and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to ... plan for the statistical analysis and reporting of clinical drug and vaccine projects.Set direction for the analysis and reporting deliverables.Negotiate and… more
