- 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 ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …informed decision-making with management Demonstrated track record of portfolio and project management , with the ability to work across all functions with ... management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence and… more
- 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 ... encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and...ideally including time in role such as a Global Project Leader at Sr. Director level or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3...team members, and to a limited extent with senior management , and outside vendors; works independently for all phases… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed ... Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and scientific input to Marketing/Market Access departments as needed Project management liaison: Assist in developing clinical program time lines, budgets, ... drug development phases, statistical research methodology experience) Leadership skills; project management skills; effective communication and presentation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position requires skills in working in a fast-paced environment, continuous improvement, project management , change and risk management . Responsibilities - ... builds and maintains positive relationships with internal/external stakeholders/vendors/partners. - Project Management : Is accountable for quality of delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies. Partner with Project Management , Clinical Operations and other ... process. Coordination with all functional areas impacted including Legal, Procurement, Project Management and Commercial or Corporate Finance, Operations.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at a project level, and interacts with regional and global project team members, senior management , and outside vendors.ResponsibilitiesResponsible for all ... studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical … more
- Insmed Incorporated (Bridgewater, NJ)
- …is a plusWorking knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …effectively interfaces within a matrixed environment and with varying professional levels Leads Clinical Ancillary Management project teams to ensure ... designing and implementing innovation/improvement initiatives, including the required change management Project Management experience including demonstrated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other ... well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of… more
- Insmed Incorporated (Bridgewater, NJ)
- … teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact… more
- Eisai, Inc (Nutley, NJ)
- …ensure adequate training and support of staff. Some travel may be required for project management and/or business development.The incumbent is expected to be a ... in neurodegenerative disorders such as Alzheimer's disease, in a fast-paced environment. Project and budget management experience.Knowledge and experience of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by ability to interpret SAPs/shells to generate ADaM and TLFs. preferred- Strong project management experience and ability to manage and execute multiple ... collaboration with other functional areas such as biostatistics, data management , clinical operations, pharmacovigilance, regulatory affairs, etc.… more
- Eisai, Inc (Exton, PA)
- …manufacturing of monoclonal antibody based therapies required.Prior contract manufacturing project management experience is highly preferred. Prior experience ... through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on the success… more
- Merck & Co. (North Wales, PA)
- …communication skills (written and oral) in addition to results-oriented project management skills Preferred experience and skills: Deep clinical expertise in ... Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of… more
- Novo Nordisk Inc. (Chicago, IL)
- …to provide deeper customer knowledge and knowledge of the region to enhance territory management of field teams Lead project teams to manage and support various ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
