- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Clinical Project & Planning Management is a member of the ... oversight and leadership across clinical programs/trials in areas of project management and planning, including related systems/tools, timelines, study… more
- Merck & Co. (Rahway, NJ)
- …fast-paced job that provides a high degree of technical, mechanical, and project management responsibility. The Equipment Development and Facility Engineering ... (EDFE) Leader position will report to the Director , Engineering and will be a member of the...Cal will be used as the facility/equipment Computerized Maintenance Management System (CMMS).Responsibilities of the MACS EDFE Leader include… more
- Merck & Co. (Rahway, NJ)
- …and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and organizational skillsWilling to travelAble to ... process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and… 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
- Merck & Co. (Rahway, NJ)
- …Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder Relationship ManagementPreferred ... Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global ...Director . The team is part of the Global Clinical Development organization and has oversight over drug development… more
- Merck & Co. (Rahway, NJ)
- …Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder Relationship ManagementPreferred ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.SummaryThis position is responsible for providing project management , drug development expertise to Global Project ... for partnering with the Global Team leader as the Project Management lead on drug development projects....these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… 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
- 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)
- …functions (eg clinical research & development, clinical science, clinical quality assurance, project management ) Preferred requiredStrong leadership, ... clinical trial operations. Experience in training, process improvement and project management a plus. required Experience QualificationsStrong experience and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical operations experience in trial diversity and patient access and/or clinical operations project management preferably with a sponsor company ... and immune disorders. SummaryThis new role is within R&D reporting into Global Clinical Operations (GCO) and the fundamental responsibility is dedicated to GCO. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg clinical research & development, clinical science, clinical quality assurance, project management ) requiredStrong leadership, collaboration, ... clinical trial operations. Experience in training, process improvement, and project management a plus. required Experience QualificationsStrong experience and… 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)
- …and may collaborate with team on CAPAs, including CAPA responses and approvals Project Management :Collaborates with the PSL(s) to proactively plan and prioritize ... to efficiently evaluate safety is desirable.Microsoft Word, Excel, PowerPoint skills, and Project management skillsAble to work independently with minimal direct… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and adverse events related to our developing assets. This role requires project management skills to oversee this complex, cross-functional workstream and ... planning and optimal execution of plans. Other related assignments may include project management , process improvement, tool generation (checklist, process map,… 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 program. This Clinical...trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project … 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)
- …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
