- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety, will lead the development and ... the safety leadership and serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources for the… more
- Merck & Co. (Rahway, NJ)
- …that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes.- dCMC intends ... for site, filing, and launch readiness Improved access to product and process data Streamlined transfer of process and product knowledge with reduced error rates A… more
- Christus Health (Irving, TX)
- Description Summary: The Application System Analyst Senior serves as a liaison between system end-users (customers), operational leaders, additional support ... assigned applications in a timely and high-quality manner. The Systems Analyst Senior will provide application support and optimization. They work closely with the… more
- Pfizer (South San Francisco, CA)
- …supports preparations for Health Authority meetings, participates as appropriate . Set the clinical data review strategy and leads the team in the collection ... in governance meetings and submissions, partners with/supports the Development lead /Medical Director regarding study and disease area strategy. Author...of quality data and review of emerging clinical data and trends; reviews and queries… more
- Formation Bio (New York, NY)
- …harmonized data product creation. Lead integration of unstructured data sources ( clinical notes, publications, documents, scientific text) using NER, ... passionate about modeling, harmonizing, and unifying complex biomedical and healthcare data into high-quality, stakeholder-ready assets. You'll lead efforts to… more
- Insmed Incorporated (NJ)
- …of products in development. You'll also:Be responsible for appropriate review of all safety data from various sources (eg pre- clinical , clinical trial ... from large volumes of scientific information.Experience presenting drug safety topics, clinical and safety data to regulatory authorities, health authorities,… more
- Eisai, Inc (Philadelphia, PA)
- …knowledge and participate in scientific exchanges and interactions with identified KOLs.Present clinical , scientific and economic data on Eisai's products and ... and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data .Demonstrate full knowledge of and… more
- Merck & Co. (North Wales, PA)
- …projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, Data Management, and other Scientists ... and ascertains needs for potential program development of novel statistical methodology.Analyzes data and interprets results from clinical trials to meet… more
- Aequor (Thousand Oaks, CA)
- …scientist to join the GCR - Process Excellence (GCR-PEX) team. This senior role balances advanced laboratory execution (cell culture, reagent generation and ... This engagement requires conformance with site policies, safety, quality, and data -integrity requirements. The successful candidate must model 's mission and the… more
- Eisai, Inc (Nutley, NJ)
- …issues arising from commercial and medical review committee submissions. Advise on cross-border data transfers (eg, clinical data ) and collaborate with ... profile, we want to hear from you. The Associate Senior Counsel, Privacy, is a strategic, business-minded, and hands-on...and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the US and Canada… more
- Formation Bio (New York, NY)
- …and IP portfolio, where you will work closely with our business development, legal, clinical , CMC, and data /engineering teams to on-board products with strong IP ... strategies that maximize asset value from in-licensing through exit Lead IP due diligence for pharmaceutical and biologic acquisitions,...Why Join Us? Impact: Shape IP strategy as our senior legal leader for a portfolio of clinical… more
- Genmab (NJ)
- …Role The Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead , primarily up until proof ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Senior Director, HEOR is a strategic leader responsible for the development and execution ... value of Insmed's gene therapy product(s) for intended indication(s). The Senior Director proactively engages and collaborates with stakeholders across the company… more
- Insmed Incorporated (NJ)
- …to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents ... can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in...1-2 indications within one compound, in collaboration with the Senior Director, Clinical Operations. Ensures consistent and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryMedical Affairs Diagnostic lead , under leadership of the Executive Director of Research and Strategy, ... in Global Medical Affairs committees as requested and processes as US Medical Affairs Lead , to gain strategic and planning alignment across the matrix team the core… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reports on documentation compliance, audit results, and improvement initiatives to senior management Lead continuous improvement initiatives related to GxP ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …Skills: Accountability, Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, ... Company's biologics pipeline. We work closely with colleagues in Discovery, Pre- clinical , and Early Development to rapidly develop processes for diverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports are properly trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of ... a coordinated and aligned strategy.Responsibilities:Operational Strategy and Oversight:Align with the Senior Director, Global Clinical Operations on plans for… more
- Pfizer (Cambridge, MA)
- … study results Support execution for all FIH programs through proof-of concept Set the clinical data review strategy, ensure quality data and conduct review ... (GDL)and members of the development team to establish, lead , coordinate, and execute the early oncology clinical...of emerging clinical data and trends; review and query data ;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead ).-Where ... complete study team list is maintained.-In partnership with the lead physician, Clinical Scientist and all study... and regulatory environment across participating regions, provide quality data and ensure timely study delivery- Lead the… more
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