- Eisai, Inc (Nutley, NJ)
- …readiness. This position is responsible for ensuring high quality execution of clinical trials from first in human through commercial marketing authorization ... training on GCP and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director , GCP Quality...of clinical trials . The position will manage cross… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials . Position Summary / Objective Serves as a primary ... medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (North Wales, PA)
- …of TMS is to provide statistical support for the pharmacology components of all clinical trials in our Company's Research Laboratories clinical development ... to late stage clinical development are proof of biology/concept clinical trials , experimental/discovery medicine trials involving novel pharmacodynamic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and standards. This position ensures quality delivery of laboratory data for clinical trials , clinical development, and regulatory submissions. This ... develops and proposes strategies for laboratory data ensuring all clinical trials meets quality requirements and best...expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serving as the primary point of contact.- Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non- clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the ... CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable ... to determine risk factors with and for other technical departments (eg, Clinical , Medical , Safety, Data Management, Statistics). This position requires skills… more
- Eisai, Inc (Exton, PA)
- …the operation of equipment to support preclinical and phase I to III clinical trials . Supervise change-over activities. Be responsible for ensuring routine suite ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...your profile, we want to hear from you.The Associate Director of Biologics Operations Upstream and Downstream is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … and screen failures. Clinical trial protocol development and reviews ( clinical trial protocols and medical device protocols)ICF reviews to ensure ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Genmab (NJ)
- …(eg competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the ... of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the… more
- Eisai, Inc (Nutley, NJ)
- …clinical development in that he/she will be responsible for designing clinical trial , performing data analysis, supporting regulatory interactions, overseeing ... clinical development in that he/she will be responsible for designing clinical trial , performing data analysis, supporting regulatory interactions, overseeing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming preferred- 7 or More Years proven… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials . Recognizing that this development bottleneck may ultimately limit the number ... capabilities to accelerate all aspects of drug development and clinical trials . Formation Bio partners, acquires, or...treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.Proactively identifies and manages risks ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
