- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies in late stage developmentLead and manage the multiple late development and/or transitioned asset Clinical Science Asset Leads ... be the Clinical Science Group Lead in late phase development in the Global ...Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical ...to be shared with KEEs; Frequent involvement in Business Development activities for late stage compounds; Involvement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 in ... Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch- Leads CDx Partner evaluation and selection,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in data science / business intelligence / statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or ... end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for the future, ... will work closely with cross-functional project teams, including Clinical Development , Clinical Operations, Biometrics,... development and regulatory requirements of a clinical program. The Director will provide high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study: provide input on the development of study protocol (design, ... least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research,...More Years Experience in oncology Therapeutic Area and/or in late phase projects is preferred Travel Ability to travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- Knowledge of all phases of drug development , including early and late phase clinical development and submission preferred- Solid background in ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for the future, ... part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail… more
- Insmed Incorporated (Bridgewater, NJ)
- …in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD degree, board ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role in working with… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development organization will ... support assigned clinical pharmacology projects in the clinical development programs for an expanding portfolio...and design clinical pharmacology studies and provide clinical pharmacology support to late phase … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for the future, ... About the Department Our East Coast Global Development Hub brings together the best minds in...internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for the future, ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a...program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical Writer is… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development , the role focuses on LC-MS/MS of small ... , nonclinical and biomarkers studies. This translational role resides within the Clinical Development organization, works closely with colleagues in other… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …with Biostatistics [ clinical and medical affairs], data science, regulatory, clinical development , medical writing, and other vital functions and represent ... marketed medicines and novel product candidates, from early- to late -stage development , in neuroscience and oncology. We...studies, and planning the operational aspects of all new clinical studies. The Director will support Integrated… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …with Biostatistics [ clinical and medical affairs], data science, regulatory, clinical development , medical writing, and other vital functions and represent ... marketed medicines and novel product candidates, from early- to late -stage development , in neuroscience and oncology. We...studies, and planning the operational aspects of all new clinical studies. The Director will support Integrated… more
- J&J Family of Companies (Raritan, NJ)
- …Family of Companies, is recruiting for a Director /Senior Director , Clinical Rseearch Physician for ** Late Development Oncology** . The preferred ... Medical Director / Sr. Medical Director , Clinical Development -...with the clinical project scientist team and Clinical Leader in Late Development ,… more
