- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Senior Director of Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities ... within clinical development. This role is accountable for designing and...objectives.Leverages extensive knowledge of strategic sourcing best practices to guide and lead teams toward achieving business goals.Oversees Outsourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead) is fully informed of the overall portfolio status ... This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include building and… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP)… more
- UCHealth (Peyton, CO)
- …standards are included in evidence based care models for each unit Clinical Educators support and guide individualized specialty education and training ... UCHealth Welcomes new knowledge in a fast paced, innovative clinical environment Contributes to secure safety and quality at...for competency validation throughout clinical orientation. We improve lives. In big ways through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Analysis App BuildObjective: Build POC for interactive dashboards to automate exploratory clinical data review and analyticsKey Tasks: Create R Shiny components for ... Kaplan-Meier curves). Optimize app performance and interactivity for large clinical datasets.Deliverables: POC for functional exploratory analysis Shiny dashboard… more
- ALPCO (CA)
- …research and medical diagnostic industries. Customer segments include routine clinical laboratories, biotech and pharmaceutical R&D groups, CROs, and academic ... The Field Applications Specialist will serve as a trusted advisor to clinical , academic, and pharmaceutical customers, functioning as both a technical problem-solver… more
- Merck & Co. (North Wales, PA)
- …quantitative skills with experience conducting statistical analyses in a clinical research settingProficiency in statistical programming (SAS and/or R)Proven ability ... testing, and implementation of a comprehensive data analytics framework to guide the process of managing, analyzing, reporting, and interpreting real-world biomarker… more
- BioAgilytix (San Diego, CA)
- …Manager II will lead scientific and operational activities in support of preclinical, clinical , and product release studies for our San Diego lab. This role requires ... protein binding, CYP inhibition/induction, CYP phenotyping, and metabolite profiling/ID. You'll guide a team of scientists through assay development, validation, and… more
- UCHealth (Littleton, CO)
- …standards are included in evidence based care models for each unit Clinical Educators support and guide individualized specialty education and training ... UCHealth Welcomes new knowledge in a fast paced, innovative clinical environment Contributes to secure safety and quality at...for competency validation throughout clinical orientation. We improve lives. In big ways through… more
- Merck & Co. (North Wales, PA)
- …for world-wide regulatory application submissions of drug and vaccine clinical development projects.Be accountable for submission data standards planning activities, ... keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.Responsible for continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within Global Oncology Medical Affairs, Regional Medical Affairs, Precision Medicine, Clinical Development, RWE/HEOR, Discovery and Business Development as well as ... decisions- Influence and inform cross-functional strategies across Precision Medicine, Clinical Development, Commercial and Market Access strategies to enable… more
- Insmed Incorporated (NJ)
- …are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.) Guide project team members on CSV projects ensuring team members follow laid out ... systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in Clinical … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will ... with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems at the CAR-T Raritan SiteReview and… 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
- UCHealth (Steamboat Springs, CO)
- …and AACN's practice standards and certifications including RNC-OB, C-EFM, NRP and CCRN guide evidence-based care models Clinical Educators support and guide ... to healthcare and/or UCHealth Welcomes new knowledge in a fast paced, innovative clinical environment Contributes to secure safety and quality at the point of care… more
- UCHealth (Lakewood, CO)
- …unit nurses, hospital supervisors and physicians to facilitate best care outcomes. Clinical educators support and guide individualized specialty education and ... to healthcare and/or UCHealth Welcomes new knowledge in a fast paced, innovative clinical environment Contributes to secure safety and quality at the point of care… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functionally with multiple functions and groups throughout the US organization, Clinical Development, Research & Early Development, other affiliates, and the Global ... Proven knowledge of the pharmaceutical industry, including medical, regulatory, and clinical processes Experience with product launches and lifecycle management In… more
- Eisai, Inc (Atlanta, GA)
- …sales goals, and coaching Sales Representatives on critical selling skills, clinical expertise and business acumen. Responsibilities: Develop and implement sales ... regional and corporate sales goals in a compliant manner. Oversee and guide all sales activity in district and coordinate collaboration of prescriber-level selling… more
- Insmed Incorporated (NJ)
- …are complete for project team members (CSV SOP, Test Execution, Gdoc. Etc.) Guide project team members on CSV projects ensuring team members follow laid out ... FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.Strong technical writing skills for authoring, reviewing and… more
- Insmed Incorporated (NJ)
- …with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across Insmed's ... containment, recovery, and post-event reviews with a focus on continuous improvement. Guide the adoption of AI-driven threat analytics, secure DevOps practices, and… more
