- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of ... and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management, important safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and ... time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical Research Associates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… 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 of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting will drive ... creation of demand and revenue forecasts. The Associate Director is a dynamic member of the Global Oncology...forecasts of inline brands and assets / indications in clinical development.- Support commercial assessment of Early-Stage assets for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies ... Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...Clinical Team Leader to ensure a high performing Clinical Sub-team and to drive the development and delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assessments of scientific and therapeutic hypotheses, as well as preclinical and clinical data. preferredAbility to drive projects to deliver timely results and ... follow through on internal and external commitments. preferredStrong communication skills to effectively convey business strategies and capabilities internally and externally, present individual and team recommendations clearly and concisely, and foster… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good ... Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This… more
