- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... under some supervision to solve complex study problems. Responsibilities Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations, Clinical Development , Biostatistics and Data Management, ... and technical feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP), ... Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& ManagementOversight of Data Request processing by Service ProvidersTraining and development of Service Provider resourcesFacilitates and participates in vendor and ... 8.0.x and 7.0.x Patches.Experience with SQL programming/querying, custom report design/ development from Argus Safety backend database.Strong knowledge of Oracle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including dictionary support documentation. Collaborates cross-functionally with the Medical, Clinical Development , Clinical Scientists, Clinical ... integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study… more
- AbbVie (Branchburg, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , Clinical Development will have ... based in Branchburg, NJ or Irvine, CA. Responsibilities: The Associate Director will be responsible and accountable...Director will be responsible and accountable for the development , implementation, and delivery of the global clinical… more
- Bristol Myers Squibb (Madison, NJ)
- …of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of innovative ... strategies and technologies for clinical trial programming. Associate Director ...Sciences (GBDS), with external vendors and members of cross-functional development teams. Associate Director , Statistical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Ensures trial master file is complete and accurate for assigned stud(ies). + If assigned, Associate Director , Clinical Operations may act as the Study Team ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** Job Description ** Associate Director , Clinical Pharmacology - Oncology** **_*This is ... provides input into product development strategies and/or research or clinical development plans for assigned products / projects. + Typically authors the … more
- Bristol Myers Squibb (Summit, NJ)
- …and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data ... discovery and translational scientists, project leadership, early and late clinical development teams and commercial colleagues to...in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative ... around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving global … more
- IQVIA (Parsippany, NJ)
- …Hub (COOH) team. The Clinical Training Manager or Associate Director will be responsible for the development and implementation of learning programs ... ensure the delivery of business results. **Responsibilities** + Responsible for the development and delivery of aligned training, as well as, foundational and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management ... including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and… more
- Bayer (Whippany, NJ)
- …member of the US Medical Affairs Oncology team, the Associate Medical Director , Prostate Cancer will support the development and execution of high quality ... to make a real difference, there's only one choice.** ** Associate Medical Director , US Medical Affairs Oncology,...Support the Senior Medical Director (s) and Medical Director (s) in the development and execution of… more
