- Insmed Incorporated (San Diego, CA)
- …leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on ... risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.Must be able to foster a collaborative environment, adapt to other… more
- Formation Bio (New York, NY)
- …while ensuring these capabilities evolve into robust, production-ready systems .Responsibilities Lead the Platform Science arm of Data Science, building ... Bio, you will lead one of two critical arms of our Data Science function, focusing on building predictive capabilities that drive our drug acquisition and… more
- Formation Bio (New York, NY)
- …mentorship, and platform thinking. You'll lead the design of scalable systems that transform both structured and unstructured data into trusted, usable ... efforts to ingest and transform unstructured and structured research, biomedical and clinical data into high-quality, actionable assets that power discovery and… more
- Merck & Co. (Rahway, NJ)
- …BI&A, will: Execute solutions to business needs by designing and implementing new data management systems Employ innovation and technology solutions to manage ... Strategy and Strategic Roadmap, supporting the organization's transition toward future-ready systems and modern data architectures. Primary Activities Design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety reviews (ie, ILD). Collaborate with Clinical Development and Clinical Sciences for effective data surveillance Qualifications: Successful candidates ... Develop and drive R programming, package, and R shiny app development. Lead the R programming implementations. Represent programming in DS external collaborations on… more
- Eisai, Inc (Louisville, KY)
- …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. (Chicago, IL)
- …Clinical Medicine, Cross-Functional Teamwork, Dermatology, External Engagement, Good Clinical Practice (GCP), Healthcare Delivery Systems , Healthcare ... with applicable policiesMaintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the… more
- Merck & Co. (Rahway, NJ)
- …and/or regulatory inspections. Independently performs audits of batch documentation, data , information, procedures, equipment and systems , and/or facilities ... review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release, and maintenance in support of… more
- Merck & Co. (San Francisco, CA)
- …validation/PPQ, commercial manufacturing, and process and plant modeling.General understanding of data sources and IT systems (eg, Signals, Analytical Instrument ... DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Project Manager will streamline… 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
- Eisai, Inc (Nutley, NJ)
- …to prepare medical affairs personnel to enter strategic and compliant discussions regarding medical/ clinical data on Eisai products. The AD assumes a leadership ... initiatives including treatment landscape training (disease state and Eisai product data , pre- clinical data , experiential training, "special topics"… more
- Merck & Co. (Rahway, NJ)
- …& medical affairs plans for their assigned Therapy Areas (TA). They build and lead a team of TA dedicated global and regional directors and associate directors. The ... the countries, that guides TA scientific exchange (input and output) and real-world data generation of all Research & Development (R&D) V&I staff globally in… more
- Eisai, Inc (Boston, MA)
- …due to Alzheimer's disease (AD) or mild AD. The Area Business Leader (ABL) will lead a team of Neurology Account Specialists (NAS) that are part of a diverse team ... exceed sales objectives. This will be accomplished by conveying complex clinical information to customers and key stakeholders regarding FDA-approved indications of… more
- Eisai, Inc (Indianapolis, IN)
- …hear from you. The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ... (S-suite, C-suite, KOLs, Pathway and PandT committee members). Each ABL will lead account responsibility for a defined number of potential strategic accounts and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… 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 ... Operations groups to support the supply of DS/ADI for pre- clinical and phase I to phase III clinical...III and PV at CMOs at the company's discretion.5. Lead and assist in troubleshooting upstream and downstream process,… more
- Merck & Co. (Rahway, NJ)
- …Biological Engineering, Biomedical Engineering, Bioprocessing, Chemical Engineering, Chromatography, Clinical Process, Data Analysis, Decision Making, ... Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Lundbeck (Fort Wayne, IN)
- …transform lives. It's a very exciting time to join our team as we lead the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager, ... you lead the promotion of our infusion product, driving demand...our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the… more
- Eisai, Inc (Nutley, NJ)
- …hear from you. The Regional Thought Leader Liaison (RTLL), Alzheimer's Disease will lead and execute regional and local engagement with existing and emerging Key ... podium presentations, 1:1 interactions, etc.Remain on the cutting edge of data readouts (consistent with FDA-approved labeling), medical congress meeting outputs and… more
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