- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) Group Lead will be responsible for overseeing ... mid-term, long-term). These will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global Clinical Operations,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will ... collaborate with global, cross- functional team-members including clinical directors and study managers to lead/support clinical trial scientific-activities.Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level or senior director level, depending on the scope and size of the asset program . This Clinical Science (CS) lead will be responsible for leading and ... managing one or more clinical scientists, oversee a program of ...science lead will also participate in the creation and management of new clinical science group from… more
- Merck & Co. (North Wales, PA)
- …within the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical ... experience in clinical biomarker assay execution and demonstrated success in project management . As a key contributor to the clinical biomarker strategy, you… more
- Eisai, Inc (Nutley, NJ)
- …and/or consultants. Contributes to management of key portfolio and program management managed service providers including financial management ... environment and developing procedures for successful implementation.Americas IT Portfolio / Program / Project Management Office Services and Operations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... the site feasibility assessment from a physician's perspectiveMay provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materialsSupports overall program safety… more
- Merck & Co. (North Wales, PA)
- …support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data Management , and our ... of clinical trials to the project team, our company's Management , regulatory agencies, or individual investigators.Provides responses to queries relating to… more
- Merck & Co. (Rahway, NJ)
- … clinical trial projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines approach and ... medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and...pose an undue burden to business operations, in which case you may not be offered employment, or your… more
- Merck & Co. (North Wales, PA)
- …deliverables for R&D projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines approach ... be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Merck & Co. (North Wales, PA)
- …for Research &Development projects (data, analyses, tables, graphics, listings)Strong project management skills; leadership at a program level; determines ... when opportunities arise. Primary Activities :Programmatically synthesize preclinical / clinical data into analysis ready structures from varied data sourcesCreate… more
- Merck & Co. (Rahway, NJ)
- …availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. Work collaboratively with various partner groups ... continuity.The FLEx sterile area supports the formulation and filling of clinical , stability, and developmental supplies for biologics and vaccines, including… more
- Merck & Co. (Rahway, NJ)
- …(EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and Development ... improve outcomes for patients.The EDSA leads a large investigator-initiated studies program in partnership with late-stage development teams in Medical Affairs while… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... provides a high degree of technical, project, and people management responsibility. - This SSO Facility Lead role within...members to ensure the quality and safe delivery of clinical supplies, the scientific rigor of the processes, and… more
- Merck & Co. (Rahway, NJ)
- …in the role of-Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical...supporting the QP2-I/O Function Lead on oncology development teams.Data management and analysis.On the job, working with senior scientists… more
- Merck & Co. (Rahway, NJ)
- …process development, qualification, and validation; and, design control and risk management techniques to positively support and influence clinical and ... ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key company functions.Represent Device… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external ... site feasibility assessment from a physician's perspective- May provide clinical input into the eCRF ( Case Report...management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program … more
- Merck & Co. (Rahway, NJ)
- …of work that includes direct project support of the current our Company clinical pipeline and prospective technology development that enhances our ability to deliver ... on the pipeline of the future. This management includes oversight of laboratory-based process development and characterization, scale-up and activities to support… more
- Merck & Co. (Rahway, NJ)
- …IT program , including evolution of the product model, workforce/resource management and demand management .Manage team of 4 Finance professionalsManages ... in our Research & Development Division IT spanning the LROP including Discovery, Clinical and Regulatory.This role also supports the SVP of the Chief Technology… more
- Merck & Co. (Rahway, NJ)
- …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 ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
