- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... Degree preferredExperience Qualifications7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or… more
- Merck & Co. (Rahway, NJ)
- …Vaccines AR&D, Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply , CMC Regulatory, Quality, and Commercial-facing ... Analytical Validation team to serve as an Analytical Program- Lead . The lead must take charge in...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… more
- Merck & Co. (Rahway, NJ)
- …Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research ... availability of Clinical Supplies and Development Batches to meet Clinical Development Program requirements. This will require project /initiative leadership,… more
- Merck & Co. (Rahway, NJ)
- …relevant experience. Required Experience and Skills: Experience working in a GMP clinical or manufacturing supply facility.Experience with small molecule drug ... in a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report to the Associate… more
- Merck & Co. (Rahway, NJ)
- …connectivity between the functions supporting the pipeline (ie- quality, regulatory, clinical development; chemistry, manufacturing, and control (CMC); supply ... include authoring technical reports and regulatory documents, presenting technical data, and project management. You will serve as a senior scientific leader and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …business processes and effective reporting systems to support reliable commercial and clinical supply . It also involves leading communication and collaboration ... principles, processes, technologies, and talent management.Key Responsibilities Develop and lead an effective manufacturing and supply organization, supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or ... new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader; Responsible before the IST for the creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities:Study Strategy: Clinical study leader (CSL) or ... new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project Team (OPT) leader; Responsible before the IST for the creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of ... with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... 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. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...are likely to benefit from our therapeutics.Contributes to CDx project teams for the diagnostic, under the direction of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and people skillsDemonstrated leadership qualities with the ability to act as project lead in the development and implementation of projects, processes ... responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting technological and data innovation, insights… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Team. In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the ... Global Project Team to drive scientific decision-making both from non- clinical and clinical translational aspects, through close collaboration with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manage a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to ... Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... be responsible for end-to-end process for CDx Implementation in clinical studies. They will ensure that sample testing and...of Dx devices under design control process. They will lead identification and selection of Dx assays and partners… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 the end-to-end lifecycle of biosamples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but not limited to near… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... interactions with cross-functional team members and leads complex discussions at the project team level as well as at governance meetings. This position… more
