- Merck & Co. (Rahway, NJ)
- …the development, analytical validation, and testing of histopathology-based assays for clinical implementation and advancing digital pathology within our ... knowledge of the drug development process and translational medicine.Experience in clinical biomarker development or managing the implementation of biomarker… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies. Responsible for ... incorporated into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical Operations:Ensure high quality delivery of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros or tools to ... knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred- Advanced understanding of statistical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs to generate standard ADaM dataset and TLFs, support training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide ... knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred- Advanced understanding of statistical… more
- Aequor (Newbury Park, CA)
- …- remote role, 40hrs a week. Job Details: Manage the development and implementation of clinical and commercial raw material specifications and other ... specification related documents. Have an understanding and knowledge of raw materials used in the manufacturing of biologics and small molecules (Media, Chemicals, Excipients, Single-Use Components, Filters, Resins, Primary Containers). Interface… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of ... clinical trial execution within a pharmaceutical or biotechnology company....processes in an industry setting.Proven track record of successful implementation of innovative strategies.Experience in managing and directing related… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Programming Manager, Clinical Programming is responsible for ensuring integrity, consistency and adherence to Study ... and systems. This role reports to the Director, Team Lead of Clinical Programming.Responsibilities/tasks - including but not limited to:Implements and assists on… more
- Taiho Oncology (FL)
- …of clinical research. The Sr. Manager, Medical Field integrates clinical /scientific expertise and knowledge to ensure successful implementation of the ... Product/Therapeutic Area Support to External Stakeholders: Act as the primary clinical /scientific resource to HCPs in a specified geography for information… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced ... and risk managementResponsibilities: Leadership, Direction, and Strategy:In collaboration with Clinical Development and Clinical Operations as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and ... validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the end-to-end delivery of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This position… 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 ... the Upstream and Downstream Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical studies, including the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …before and after CDx testing, for less complex projects.At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into ... clinical testing (before testing) and once data is ready...to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both… more
- Merck & Co. (Upper Gwynedd, PA)
- …resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses, ... reimbursement. The incumbent is expected to work cross-functionally with clinical development, medical affairs, biostatistics, market access, commercial and country… more
- Merck & Co. (Rahway, NJ)
- …the US Leader for Medical Modernization (MM) will oversee the development and implementation of new content, tools and scientific engagement capabilities for the V&I ... construct for digital communications to US SL/KDMs and oversee the E2E implementation of these digital communications. -The US lead will help transform scientific… more
- Aequor (South San Francisco, CA)
- …presentation of past work for 45min. The Computational Biology group in the Clinical Biomarkers & Diagnostics (CBD) department at is seeking a highly motivated Sr ... modeling and prediction pipelines using multi-modal biomarker data from clinical trials. Responsibilities Maintain and develop in-house endpoint association and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …team. Direct education for healthcare professionals treating oncology patients on clinical data, adverse event management, and mechanism of action for commercial ... Affairs strategies and tactics.Assist in the oversight of Legend Biotech sponsored clinical trial sites to include, but not limited to, site identification, patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection Supports Regulatory affairs in providing ... this position are to assist in the development and implementation of companion diagnostics (CDx) strategy in support of... of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Teams, Field Reimbursement Managers, Field Sales Forces, Marketing, Oncology Clinical Nurse Educators, Oncology Market Alliances and other appropriate stakeholders. ... gaining cross function inputs and lead the projects' execution, tactical implementation , and sustainment leading to improved observable measures. This individual is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US market needs and critical success criteria are addressed ie clinical development programs, data generation needs, international guidelines, required efforts by ... Evolution o Establish product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies to… more
