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The Associate Director, Portfolio Management Insights, Portfolio & Strategic Operations (P&SO), drives portfolio management insights development and delivery to the Global Program Teams (GPTs), Therapeutics Areas (TAs) leaders, Hematology Oncology Cell Therapy (HOCT)/Immunology Cardiovascular Neuroscience (ICN) leadership, crucial for strategic decision-making within the drug development portfolio.
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Knowledge in project management and CMC regulatory requirements. Provide technical and project support for IDEAYA pipeline across all stages of research and development in terms of quality, timeline, and cost.
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Collaborate with internal and external CMC functions including project management, chemical development, analytical development, and supply chain to align priorities and project timelines.
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The selected candidate will manage integrated drug development projects across the full scope of the development paradigm and ensure projects are delivered on time, budget, and with high quality using proven project management decision support tools and strong leadership skills.
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Strong track record in drug product development, CDMO management, and largescale manufacturing. Build relationships and lead outsourced drug product development and manufacturing activities including contracts, timelines, and budgets a to meet overall project timelines.
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We are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects.
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The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company. In addition to project work, the Associate Director is expected to contribute to ongoing business process improvement and talent development in Global Project and Alliance Management (GPAM.
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The individual is expected to identify and participate in establishing and improving project management tools and processes across the drug discovery and development portfolio to support various strategic initiatives.
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This to facilitate operational excellence in all business processes in support of argenx’ drug development projects and PMO’s process improvement projects and tool introductions e.g., through sharing best practice, creation and management of templates, trackers, and business process documents.
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0 years: Masters Degree- Emphasis in synthesis, pharmaceutical development, or natural products chemistry, and project management experience in drug development, pharmaceuticals production, or similar project efforts.
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Knowledge of pharmaceutical industry and Project management experience within Medical Affairs, Clinical Research, Regulatory, CMC, Marketing or other drug development related function.
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Should have good working knowledge of all areas of development - including CMC, non-clinical, clinical, project management and regulatory functions. Combined with either/or experience above a minimum of 5 year of experience in project management, leading multi-disciplinary project teams through the various phases of product development is preferred.
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Expertise in the application of project management software (e.g. MS Project) and in the use of the project/portfolio management systems required. Is expected to critically evaluate opportunities involving commercial/licensing/partnership/intellectual property activities related to the project(s); should be able to provide complete development strategies and budgets as needed.
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10 years of experience in the pharmaceutical industry including 5 years in a relevant drug development project management role. The Director, Global Drug Development Project Manager will deliver goals across the global development and Project Management organization to accomplish annual business plan goals.
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Provide strategic direction and leadership in rare disease drug development project management, aligning projects with organizational goals and objectives. Proficiency in project management methodologies, tools, and techniques to plan, execute, and monitor drug development projects from initiation to completion as recognized by the Project Management Institute (PMI.
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project management development jobs Title: drug development
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