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As a pivotal leader in the Market Access & Pricing and HEOR team, the Sr. Director, MA&P, for Rare Diseases will drive the strategic development and hands-on execution of access, reimbursement, and commercialization efforts for Moderna's innovative Rare Disease portfolio.
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Establish and execute on a strategic roadmap for biostatistics, statistical programming and data management for Dyne as we prepare for commercialization. Proficiency in statistical programming languages (e.g., SAS, R) and clinical data management systems (e.g., Medidata Rave, Oracle Clinical) is essential.
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CMC team leadership experience managing cell therapy programs through product life cycle from pre IND through clinical and commercialization stages - propensity to thrive in fast-paced, multifaceted, matrixed team environment, ability to comprehend the big picture and also strategically drive execution details for CMC deliverables.
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Strong life sciences corporate strategy and/or transaction execution experience, including: new opportunity prioritization; partnering and M&A strategy; business development and transaction support; M&A and/or licensing execution; private placement execution; asset forecasting and valuation; portfolio management; or commercialization strategy.
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Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals Oligonucleotide regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages.
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This position supports and manages product development activities and projects from concept through commercialization, including, but not limited to trend monitoring, concept development, raw materials sourcing, benchtop development, raw materials sourcing, benchtop development, designing and managing trials and start-ups, writing technical reports and documenting procedures.
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The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under INDs/CTAs and transition to appropriate GMP validation to move expeditiously in Phase 3 trials with material suitable for commercialization to support market access for Voyager's gene therapy products.
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May direct staff to perform internal due diligence of commercialization pathways and potential licensees. PhD with minimum of 5 years directly relevant business development, licensing, IP management, technology commercialization or deal making experience, or.
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An in-depth technical knowledge in all commercialization aspects (commercial, market access and medical) and most preferably strong knowledge of the disease areas of interest. IgAN Global Commercialization Strategy Development: Formulate and implement global commercialization disease strategies, launch plans, and tactical plans for IgAN across all assets in development.
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Lead immunoassay development projects, from concept through to commercialization in a quality compliant environment. We are looking for an experienced and highly motivated Senior Scientist to join our Reagent Research & Development team, in roles focused on driving expansion of our Single Molecule Array (Simoa) assay portfolio though development and continuous improvement of immunoassay reagent kits.
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Develops commercialization plans for major assets in an IP portfolio; including documenting the process by which a new product or service may be introduced into the market, taking into account the developmental needs of the technology, production requirements, financial projections, market analysis and other factors required to achieve commercial success.
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Co-Develop with the business and Implement Sourcing Strategies, Create and execute sourcing strategies to support the development and commercialization of cell and gene therapy products. Minimum of 7-10 years of experience in strategic sourcing, procurement, or supply chain management, with a focus on CDMO for Cell and Gene therapy or biologic in the pharmaceutical or biotechnology industry.
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They will be motivated by the opportunity to bring a rare disease commercialization mindset and to build their markets which will lay the foundation for the success of Pyrukynd and Agios’ pipeline of transformative rare genetic disease treatments.
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The Systems Engineering team guides in the identification, development, commercialization and improvement of drug delivery technologies to provide optimal patient experience in administration of Amgen's therapeutic products.
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Develop and/or improve formulas and recipes using analytical data coming from Differential Scanning Calorimetry (DSC), Dynamic Hybrid Rheology (DHR), tempering curve analysis (Temper Index, slope, crystallization), and similar technologies.
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commercialization job Title: engineer Company: Genesis Research in Woburn, MA
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