- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SUMMARYDevelop the strategic ... direction for Global Research QA including activities under GLP,GCLP. Translational ...to deliver on GLP/GCLP commitments that are pivotal to early phase submissions.Collaborate with Global QMS to build a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position serves as ... the Clinical Safety Scientist Lead for a large, late-stage program or multiple early -stage programs, in order to proactively perform safety surveillance and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees one ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Merck & Co. (Rahway, NJ)
- … & Development within DSCS: -organization is responsible for process development and early clinical supply manufacture of drug substance across all modalitiesIn ... Description: Director , Analytical R&D and Process R&D, Development Sciences & Clinical Supply Finance The Director will oversee a team of five… more
- Merck & Co. (Rahway, NJ)
- …(Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed oncology medicines. ... pre- clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.Developing of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary The ... of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late-Stage Development Portfolio. The individual will play a key role… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our ... pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of… more
- Merck & Co. (Rahway, NJ)
- …Affairs (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and ... leadership experience after completing postgraduate training in cardiovascular medicineSignificant research experience as lead clinical investigator, specifically… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Key Functions Reports to… more
- Merck & Co. (Rahway, NJ)
- …in Small Molecule Global Science, Engineering, & Commercialization (SM GSEC) The Director , DCT Leadership position in the Manufacturing Division is a dedicated ... Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing.- Deep understanding of connectivity… more
- Novo Nordisk Inc. (New York, NY)
- …new areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, Development, innovation hubs across NN, other ... development of direct-to-patient materials, tools and programs. Reports directly to Regional Director - Rare Blood and interacts with other Rare Blood Community… more
- Organon & Co. (Jersey City, NJ)
- …(TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting ... + Good working knowledge of regulatory guidances and requirements pertaining to early clinical development including clinical pharmacology guidelines and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP ... as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …biomarker development, precision medicine, and disease biology research . The Medical Science Early -Stage group of Early Clinical Development serves as a ... of the Medical Science Early -Stage, the Director , MSES will lead clinical and scientific...pivotal bridge between Discovery/ Early Development Research and the later phase Clinical Development… more
- Bristol Myers Squibb (Summit, NJ)
- …The CP&P team interacts with discovery and translational scientists, project leadership, early and late clinical development teams and commercial colleagues to ... clinical pharmacology and Pharmacometrics experience + For Sr. Research Investigator, with Ph.D. approximately 2+ years experience with demonstrated progression… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …2017 and RADICAVA(R) (edaravone) oral suspension in 2022. The company handles research , clinical development, sales, marketing, medical affairs, supply chain,and ... on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs ( Early Development) provides strategic global regulatory… more
- Sanofi Group (Bridgewater, NJ)
- ** Early Pipeline Respiratory Medical Director ** **About Sanofi** At Sanofi, we are committed to the growth of our people, connected in purpose by career, life, ... impact on millions of patients around the world. **Job Responsibilities:** + The Early Pipeline Respiratory Medical Director reports to the Global Medical Head… more
- Sanofi Group (Bridgewater, NJ)
- …dermatologic, respiratory, and gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports ... Team:** At Global Medical Immunology, we support Sanofi's commitment to scientific research by developing first-in-class treatments and a pipeline of new medicines… more
- Pfizer (New York, NY)
- …Provides input to the operational strategy and feasibility of clinical research studies, in conjunction with the Development Director , Operations Manager, ... Medicine RU (IMRU) will be the thought leader driving clinical research for the expanding area of...will be responsible for creating the overarching strategy for early clinical development programs with a focus… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of action and drug landscape to propose, design, and implement clinical research and development studies for early and/or late stage assets; able to ... team and may contribute to candidate development projects through early and/or late phase development. The Director ...process, Good Clinical Practice, complex study design, clinical research methodology & medical writing skills.… more
