- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary As Translational Strategy Leader, you will define and lead cross- project translational strategy and guide research across immunology related projects in ... as well as external research, (2) determine the implications for cross- project strategy, and (3) coordinate pre-clinical/clinical research plans to progress the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plus Must understand the entire development process through engineering program and project management, conceptual design , detailed design , prototyping, ... Position Summary:The Project Engineer (Finishing/Filling) is responsible for ensuring new...appropriately within the team and expected designed timelines. The Project Engineer will ensure timelines are met, budgets are… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish and manage relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & ... relationships positively with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement/innovation projects for NACD… more
- Tris Pharma (Monmouth Junction, NJ)
- …talent across the organization and by applying overall and specific project management and organizational leadership expertise to the clinical development portfolio. ... timelines, cost of services, etc.; Provides operational and scientific strategy, design and execution for multiple programs across various therapeutic areas… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design , data analysis and interpretation of results ... and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for, and executive oversight of, Clinical Operations matters relating to the project portfolio anchored within the East Coast Hub, including trial planning, study ... / protocol design and development, execution within budget and timelines, quality...and joint responsibility across projects, eg, via working groups, cross- project collaboration and HQTM Council initiatives Lead by example;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct ... aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical pharmacology objectives with… more
- Merck & Co. (Rahway, NJ)
- …and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) ... health.- In this role, the individual will be responsible for leading CMC project teams and the formulation development of new chemical entities through a matrix… more
- Insmed Incorporated (Bridgewater, NJ)
- …Research groups. The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they relate ... for pharmacokinetic and biomarkers studies.Accountable for the scientific guidance and design of the bioanalytical translational and clinical strategies and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design . In addition, he/she will develop a QSP strategy to ... to address prioritization across the portfolio within Oncology/Immuno-OncologyCollaborate with multidisciplinary project teams to develop and apply QSP models to aid… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of this position are to create the model-based drug development plan, design , conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support ... Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory...and participates in KOL and regulatory interactions at a project level, and interacts with regional and global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regional entities are reflected into strategy and plans.- The GTL ensures global project team's responsibility for the identification and design of a sound, ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Merck & Co. (Rahway, NJ)
- …and scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) ... drive resultsCan independently execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management… more
- Merck & Co. (North Wales, PA)
- …of quantitative leadership in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The ... reports to effectively communicate results of safety evaluations to the project teamsMentor and guide junior staff in functional activities.Skills Education and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with technology suppliers and third-party contractors. Provide guidance to the capital project engineering function through design and installation of automation ... is directly responsible for leading the Engineering team in the successful design , construction, and commissioning of facility systems, as well as all process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including ... components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo products. This position contributes to or independently leads the design , preparation and analysis of epidemiologic studies, including real-word evidence ... independently carries out various functions (eg, literature reviews, study design , preparation of data for statistical analysis to obtain...input from upper management that impacts more than one project team at a time. This position will also… more
- Catalent (Philadelphia, PA)
- …Assurance Document Control manages the communication between the operations/production, project management, shipping and quality assurance groups to ascertain ... packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with...system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position Use medical and clinical expertise in design , implementation and monitoring of clinical studies (from Phase 1 to 4) in a ... medical & scientific input to regional evidence generation plan-ning and project strategic documents, including NNI Evidence Generation Plans and Product Development… more
- Merck & Co. (Rahway, NJ)
- …pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, ... guidelines in the application of predictive model-based approaches in the design of development plans and study designAbility to influence regulatory strategies… more
