- Vitalief (New Brunswick, NJ)
- Overview Vitalief is a pioneering, "best of breed" Research and Clinical Trial Solutions Consulting Company. We are seeking a problem-solving oriented, ... member of our exceptional Client Services Delivery team. The Director will work closely with senior management and our...while balancing costs and quality. + Responsible for enhancing clinical trial execution and enrollment through building… more
- Bristol Myers Squibb (Princeton, NJ)
- …teams to support clinical development and ensure the integrity and quality of clinical data and clinical trial subject safety. This leader will sit ... the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and proceses/systems, including for-cause and… more
- Sanofi Group (Bridgewater, NJ)
- ** Clinical Research Director ** **About the Job**...Reporting to the Global Project Head, the CRD leads clinical trial strategy and execution of assigned ... + Reviews the study specific committee charters. Leads study specific committees with operational support. + Leads the clinical interpretation of study results,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out) In order to be considered for ... The Senior Medical Director , Clinical Sciences, Hematology provides ...life may include the following responsibilities: + Manages all operational aspects and drives execution of the section of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …execution: As CSL for Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and contingency planning, Analyzes, updates ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data(eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …7 or More Years managing initiatives required **Competencies** + End-to-end clinical trial experience directing/overseeing data management services and ... as DM SME in internal audits and/or regulatory on-site inspections + Knowledge of clinical trial operations, clinical trial data flow, pharmacovigilance,… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …**How you will** **contribute:** + Oversee and direct the work of the Clinical trial disclosure programming team (within the Programming Center of Excellence) ... therapies to patients worldwide. Join Takeda as an Associate Director , Programming in Cambridge, MA, where you will oversee...Standard code, AI and ML applications). + Collaborate with Clinical Trial Transparency Teams to implement data… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Research (CESR) projects. Candidates should have a comprehensive understanding of clinical trial management, with firsthand experience managing collaborative ... around rare diseases and immune disorders. **Summary:** The Associate Director will lead the execution and lifecycle management of...to ensure timely follow-up and resolution of issues. + Clinical Trial Management: Oversee clinical … more
- Taiho Oncology (Princeton, NJ)
- …+ Present GCP updates to study teams weekly. + Review of critical clinical trial documentation and documents submitted to regulatory agencies, ability to ... and best practices; lead GCP advisory role. + Lead and conduct audits at Clinical Trial Sites and Contract Research Organizations. + Provide interpretation of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Data Management and Clinical Development. **Responsibilities** + Designs and leads clinical trial sample testing activities and data capture to support CDx ... submission or associated drug regulatory submissions + Responsible for implementation of clinical trial assays at Diagnostics Partners, reference labs and… more
- Bristol Myers Squibb (Princeton, NJ)
- …in late stage drug development and activities required for and related to clinical trial initiation, maintenance and completion + Strong verbal and written ... Read more: careers.bms.com/working-with-us . **Summary/Scope** Reporting to Senior Scientific Director Translational Medicine (TM), the TM Associate Director … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …strong relationships partnerships with IVD partners and testing laboratories + Oversee operational aspects of CDx clinical trial implementation, manage ... We are seeking a Director to join our Precision Medicine team. The...expert in oncology and able to effectively communicate with clinical study teams on program direction + Able to… more
- Bristol Myers Squibb (Princeton, NJ)
- …stage drug development + Experience in activities required for and related to clinical trial initiation, maintenance and completion + Experience in interacting ... Join us and make a difference. **Summary/Scope** Reporting to Senior Scientific Director Translational Medicine, the TM Sr. Principal Scientist will be part of… more
- Bristol Myers Squibb (Princeton, NJ)
- …GBDS Lead is a core member of the development team. Along with the clinical and regulatory leads, the GBDS Lead is responsible to provide scientific and strategic ... leadership and has a shared responsibility for developing the clinical /regulatory strategy. Among other things, the GBDS Lead provides strategic input into the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …or related field with 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related ... The Director of Statistical Programming Medical Affairs provides leadership...groups or individuals, crafting solutions to address business and operational challenges + We need you to regularly meet… more
- Bristol Myers Squibb (Princeton, NJ)
- …Lead and influence the collaboration with cross company expertise in drug development, clinical trial design, data science, cybersecurity, data privacy and other ... within the therapeutic area. **Position Responsibilities:** + The Senior Director , Digital Health Commercialization Lead, has the responsibility for identifying,… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Statistical Methodology works closely with Head of Statistical methodology ... functional team members to drive development of statistical methods for emerging trial design and analysis problems. This individual will also mentor junior stats… more
- Taiho Oncology (Princeton, NJ)
- …Biostatistics, PV, PK, Biomarkers and Medical Writing etc.), to deliver high quality clinical trial results. + Use scientific expertise to support the creation ... conferences and leverages the knowledge for designing and summarizing clinical studies. + Keeps Sr. Medical Director ...provides ongoing risk assessments for the study conduct and operational risks. + Performs other duties as required. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …CLIA, data management, risk management, and regulatory issues. + Demonstrated clinical trial experience in healthcare/medical/laboratory settings or equivalent. ... will s upport the strategic and tactical planning as well as operational management of biospecimens, which contribute to asset development. Our functional teams… more