- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project ... (MS or PhD). PMP is desirable. Minimum of 12+ years' experience in clinical project management ; deploying project management methods; influencing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams ... with team to resolve. Leverages their network to influence across the organization.Manages project status in the project management information systems 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)
- …leading implementation of data standards practices within vendor relationships. - Project Management :Accountable for developing and promoting the strategy and ... employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail ... Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly… 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 ... Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …treatment and adverse events related to our developing assetsThis role requires project management skills to oversee this complex, cross-functional workstream ... planning and optimal execution of plansOther related assignments may include project management , process improvement, tool generation (checklist, process map,… 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.OverviewTheDirector, Clinical Development will play an important role in working with the… 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)
- …inquiriesPreparation of abstracts and manuscripts for publicationClosely partner with Research, Clinical teams, Bioanalytics, Regulatory, Project Management , ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Clinical Science Strategy.In conjunction with Global RD Finance, Global Project Management , HR, manage the workforce planning for Global Clinical ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project … 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)
- …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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and scientific communication, technology and platforms and strong operational and project management capabilities are essential for success. Relationships ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...medical, medical information, sci. communications etc.) Demonstrated experience in project leadership, project management and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management , CMC and Regulatory ... Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research, Medical Writing, Program Management , CMC and Regulatory… more
- Merck & Co. (Rahway, NJ)
- …evaluation and shaping scientific strategy both at the platform and program level. Project management and/or scientific over-sight of work outsourced to ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...effective prioritization to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …goals, including change management and implementation planning, for GOCD non- project related initiatives. The Associate Director , GOCD Functional Excellence ... required Experience Qualifications7 or More Years 7-10 years of relevant project management , process improvement, tools development, business analyses or… more
- Merck & Co. (Rahway, NJ)
- …in a fast-paced job that provides a high degree of technical and project management responsibility. The Associate Director - Process/Facility Engineering ... position will report to the Director , Engineering and will be a member of the...molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey.… more
