- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders ... to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and validation , and tools to… more
- Merck & Co. (Rahway, NJ)
- …will play a crucial role in the supporting the development, analytical validation , and testing of histopathology-based assays for clinical implementation and ... Molecular Biomarkers is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... Associate Director writes, reviews, and/or approves GMP documents, including validation protocols and reports, and SOPs, along with providing...Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionContainer Closure Integrity Testing Lead , Associate Principal Scientist, Analytical Research & Development The Analytical Research and Development ... experience overseeing CCIT, as we establish CCIT testing capabilities for our clinical portfolio in various product images (vial, syringe, medical delivery device,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountability in data management practices. The position also involves risk-based validation of IT services and determining audit targets for GxP ... PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art...Set the strategic direction to define best approach for clinical development systems, PV systems and MA systems including… more
- Formation Bio (New York, NY)
- …will also provide analytical development oversight of pre- clinical and clinical -stage large molecule asset acquisitions and lead analytical activities at ... 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… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain Eisai's global (Veeva) eTMF ... overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decision risk, drive action plan development and ultimately improve commercial and clinical planning Design, execute and lead all capability benchmarking ... methodologies to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data… more
- Merck & Co. (South San Francisco, CA)
- …is recruiting a Senior Director, who will serve as the Computational Biology lead for Cardiometabolic Drug Discovery Data Science. We are seeking an experienced ... to generate target/biomarker hypotheses and patient stratification strategies. This role will lead a team of bioinformaticians and data scientists to apply cutting… 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
