- 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
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late -stage development , the Senior Clinical Director will manage the entire ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...clinical trials in immunology therapeutic areas. Experience in late stage IBD trials and regulatory filing is preferred.Minimum… 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
- Merck & Co. (North Wales, PA)
- …across the globe. Working with the Asset Development Team (ADT's), early- & late -stage clinical development teams, the Biomarker (BMx) leads will develop ... development for our Company's Oncology programs. Working with early- and/or late -stage clinical development teams, he/she will have the opportunity to… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD degree, board certified/eligible and/or… 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
- 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
- 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
- Eisai, Inc (Exton, PA)
- …pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on ... and oncology, with a strong emphasis on research and development . Our history includes the development of...scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for… 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
- 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
- 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
- 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, ... 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
- Catalent (CA)
- …Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an Account Director , Pharmaceutical Softgel and Late -Stage Oral Solids. This position ... geography or a portfolio of accounts. As an Account Director , you will join our dynamic Business Development...of all sizes to advance new medicines from early development to clinical trials and to the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …studies in late stage development . Lead and manage the multiple late development and/or transitioned asset Clinical Science Asset Leads including ... 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 program. This Clinical… more
- Amgen (Washington, DC)
- …. In this vital role, the Medical Sciences Director will contribute to late phase clinical development of oncology. They will collaborate on teams ... a career you can be proud of. **Medical Sciences Director - Late Development ** **Live**...drug development . Through their role, the Medical Director provides subject matter expertise in clinical … more
