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Playing a critical role as the drug product technical lead and CMC project lead, this position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy.
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Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
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As a Project Management Director, you will lead the development of Green Hydrogen projects in the North America from feasibility to start of construction. Provide leadership and ensure top performance in all areas of the project (engineering, Health Safety Environmental (HSE), permitting, regulatory compliance, procurement, construction management, project control, contracting.
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Forms cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control and Manufacturing Operations by providing SMEs to these functions and project teams.
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Our continued success is achieved through our omnichannel fluency and curated digital suite of capabilities, including Account Services, Creative, Digital and Brand Strategy, Digital Production and Project Management, 3D Animation, Digital Development, and Video.
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Collaborate with the Project Management and CMC teams and related functions, including discovery, non-clinical development, Formulation, Analytical Development, QA, and CMC Regulatory Affairs.
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Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship Management.
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Knowledge of drug development, pharmacokinetics and pharmacology principles required. The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions.
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The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents.
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A Ph. D. or equivalent degree with a minimum 3 years of experience) OR (a PharmD or equivalent degree with at least 5 years of experience) OR (an MS or equivalent degree with at least 7 years of experience), where "experience" means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
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Framing critical drug development questions for optimizing model-informed development. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and state-of-the-art modeling approaches across multiple therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management.
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Educational background in pharmacometrics, biopharmaceutics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
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This Associate Director will work with scientists within QP2 by applying one or more of the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact.
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To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. Proficiency in performing MBMA, CTS in standard pharmacometric software (e.g. R, NONMEM, Monolix, Matlab, etc.) If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.
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project management drug development jobs Title: drug development
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