- Merck & Co. (Rahway, NJ)
- …for:-Evaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Merck & Co. (Rahway, NJ)
- …expectations and shape, present and defend regulatory documents and submissions.Represent QP2 on discovery, early clinical development and late clinical ... on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for cardiac, respiratory,… more
- Merck & Co. (Rahway, NJ)
- …ForEvaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug ... all phases of clinical development (pre- clinical to post-licensure). The Senior Director will... Director will manage the entire cycle of clinical development , including study design, placement, monitoring,… more
- Merck & Co. (Rahway, NJ)
- …drugs in our company's pipeline, with a deep understanding of product development from early stage through commercialization.Actively partnering with other ... development .Defining and implementing end-to-end analytical control strategies for clinical supplies under good manufacturing practices (including method … more
- Merck & Co. (Rahway, NJ)
- …responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new ... potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy.Responsibilities- Accountable for developing the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development plan and contributes to overall development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sciences, Global Clinical Operations, Biostats and Data Management and Clinical Development . Responsibilities Designs and leads clinical trial ... as other research areas centered around rare diseases and immune disorders. Director , Diagnostic Sciences Global Companion Diagnostics Job Summary The Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a ... CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. May act as...launch. May act as CDx representative to GPT for early -stage programs.Contributes to CDx Partner evaluation and selection activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance oversight is in place and all regulations being adhered to.Ensure that Clinical Development activities (ie , protocols) are aligned with GLP/GCLP, ... of resources needed to deliver on GLP/GCLP commitments that are pivotal to early phase submissions.Collaborate with Global QMS to build a phase appropriate quality… more
- Bristol Myers Squibb (Summit, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Early Clinical Development function is part of a global scientific ... + Provides oversight and medical accountability for multiple trials across early development clinical lifecycle + Manages site interactions in partnership… more
- Pfizer (New York, NY)
- …scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues. + The Early Stage Clinical ... study delivery timelines. + The Early Stage Clinical Scientist will lead the development of...drug development especially in Early Development ; familiarity with related disciplines (biostatistics, regulatory, pre- clinical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … Director , Medical Science MSES, will be primarily responsible for creating plans for early clinical development and implementing Early Development ... of the Medical Science Early -Stage, the Director , MSES will lead clinical and scientific...research. The Medical Science Early -Stage group of Early Clinical Development serves as… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Director , Medical Science - Early Stage will be responsible for clinical development projects, successful outcome, clinical program oversight, and ... (edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, supply...As a senior member of Medical Science, the Senior Director , Medical Science - Early Stage will… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs ( Early Development ) provides strategic global ... RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, supply chain,and business… more
- Sanofi Group (Bridgewater, NJ)
- …Support in the design and execution of observational, phase 3b and phase IV clinical studies, including informing clinical development plans and study ... ** Early Pipeline Respiratory Medical Director ** **About...immunology, and respiratory experience required + Experience in pipeline, clinical development and/or medical affairs on a… more
- Sanofi Group (Bridgewater, NJ)
- …Support in the design and execution of observational, phase 3b and phase IV clinical studies, including informing clinical development plans and study ... + Significant immunology, and gastroenterology experience required + Experience in pipeline, clinical development and/or medical affairs on a global or regional… more
- Merck (Rahway, NJ)
- …+ Evaluating pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications; ... Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Director Clinical Development Date: Sep 29, 2024... early clinical and pre- clinical development in this regard. The Director will be a ... This role can be based in Parsippany, NJ or West Chester, PA Director , Clinical Development is responsible for the development , execution and… more
