- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Responsibilities Lead the development and implementation of cross- project translational strategies in applicable preclinical/ clinical immunology projects. ... immune disorders. Summary As Translational Strategy Leader, you will define and lead cross- project translational strategy and guide research across immunology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ;...meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase… 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 ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program management, ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...the overall development plan agreed to by the Global Project Team (GPT). Lead site selection and site… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 a ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other… more
- Merck & Co. (Rahway, NJ)
- …Director level reporting to an Associate Vice President in Development Sciences & Clinical Supply . The Distinguished Scientist will provide scientific direction ... and partner with the Development Sciences and Clinical Supply Digital Leadership Team to define the in silico strategy for our organization, comprising Process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance....In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Planning and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...always maintained and accurate. Accountable to the Global Team Lead (GTL) and GPT (Global Project Team)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation, Technical Support, Supply Chain) that supports daily clinical production and ... for performing training activities for Operations team members who support cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …macros and build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …technologies. Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with...packaging processesAct as the Quality partner to support the Supply Chain and Operations department. Act as site subject… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with...activities of the Manager, Training Program and the Training Lead .Cross train with Quality Systems team by supporting activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... Represents Daiichi Sankyo's regulatory group in internal and external development project meetings. Conduct completeness, scientific accuracy, and ease of review of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the ... 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
