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As a part of the global project team, the successful applicant will contribute to the development of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the strategy for clinical endpoints and develop serology, mucosal/ cell mediated immunogenicity, efficacy-supporting diagnostics, and next generation sequencing endpoints for a late stage program.
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Establish and lead the strategic gene therapy AAV vector engineering roadmap and provide exemplary scientific leadership for the company's AAV research programs to support the overall corporate strategy.
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Provide statistical leadership and technical support for Pfizer projects involving health economics and outcomes research (HEOR). Provide a strong presence for Pfizer with HTA, regulatory and professional organizations to influence knowledge generation and content of regulatory guidelines to support the adaption of health economics and patient-reported and other clinical outcome assessments.
$161,600 - $269,400 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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ESSENTIAL JOB FUNCTIONS: The Associate Director/Director Biostatistics is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results; and regulatory submissions to the FDA and other regulatory agencies.
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Serves as the Primary Liaison with CICL Faculty Directors, Technical Director, Program Manager, Quality Assurance Project Manager, IT/Systems Director, and Administrative Director for center-wide issues concerning staffing, resource projections, database-related performance, and other issues that affect the day-to-day quality and efficiency of the CICL.
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A key area for this role is strategic program management in support of utility-scale development activities, including technical resource management, interdisciplinary coordination and communication, process development, and change management.
$161,320 - $183,880 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Provide technical review of supplier batch records for development/tech transfer and related GMP documentation (e.g., raw material and product specifications, equipment specifications, validation protocols/reports.
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Technical Support: Provide or assist in technical support for facilities maintenance, working with vendors to identify and correct various mechanical, electrical, and plumbing (MEP) issues.
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Reporting to the SVP, Technical Operations, the Senior Director, Drug Development & Commercialization is accountable for helping to set the strategic direction and operational execution plans for activities that are critical to the advancement of Viridian’s pipeline drug candidates, from pre-clinical to early- and late-stage clinical to commercialization preparation and support.
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Provide direct support to Biopharma partners by communicating technical capabilities in face-to-face meetings, conference calls, and other forms of communication. Schedule and lead meetings and/or events with the purpose of driving technical decisions and cross-functional alignment, fostering team ownership and commitment to technical development plans from Feasibility to Launch stage.
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Ultragenyx is looking for a Associate Director, Project Management, Technical Projectswith a passion for rare and ultra-rare diseases, who will manage cross-functional teams to drive initiatives across manufacturing, operational, and quality-related projects related to our Gene Therapy manufacturing platform.
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Job Purpose National Grid is seeking a Product Director in our Gas IT organization to evolve our asset management technical solutions. The Product Director will play a critical role in helping us meet these targets:Guide and support delivery of our asset management solution commitments, ensuring deployed products and services meet target value outcomes and end user needsLead articulation of a clear multi-year technology capability vision and roadmap backed by quantifiable insights to deliver high value asset management outcomes This role will report to and be supported by the head of the Gas IT portfolio.
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Provide training and technical assistance for staff to support the development of financial literacy and management and skills within the team. Along with the Executive Director, staff the Finance Committee of the Board of Directors; schedule meetings and support the preparation of reports and agendas.
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5+ years in or around selling enterprise SaaS software (sales, account management, presales, partnerships, support, product marketing) Work on every detail required to get a client over the line (be it chasing a lawyer for the contract or arranging a technical lunch & learn.
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Actively lead or support marketing and technical expert (SME) outreach efforts to penetrate target accounts and position Lonza as a market leader in biologics drug product services. Adept at building strong internal network and navigating a complex matrix organization to optimize influence for ensuring appropriate support levels for territory opportunities.
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technical support jobs Title: director in Waltham, MA
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