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15+ years of pharmaceutical/biotech drug development experience with 5+ years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs/small molecules.
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10+ years of pharmaceutical/biotech drug development experience with 5 + years of experience in global CMC regulatory affairs with working experience and content knowledge in CMC development of NCEs / small molecules.
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Knowledge of the drug development process, Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP), including worldwide PV regulations and their application to safety science activities (aggregate PV reports, risk management plans, signal detection, clinical trials and clinical development.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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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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Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
$265,000 - $300,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Clinical research and/or drug-development experience in hematology/oncology required, 5 years or greater preferred. The Director will work in a multifunctional, matrix organization, working closely with colleagues within the medical affairs group (including field medical, medical operations, medical & product training, medical information, HEOR, publication management and bioanalytics), as well as those in research & development, commercial, access & reimbursement, and patient advocacy.
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Founded in 2015, the company has built a portfolio of 20+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.
RemoteExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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The Director, Project Management is responsible for managing cross-functional drug development projects, in either preclinical or clinical development stages. Minimum of ten years of relevant work experience in the biotechnology and/or pharmaceutical industry; of which a minimum of three years working in a project management role, preferably working with multi-disciplinary drug development teams.
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The Director, Clinical Operations (TMF, CTMS) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions.
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Abdera Therapeutics Inc. Is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development.
$250,000 - $315,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ph. D. degree in a relevant scientific discipline with over 10+ years' experience in the pharmaceutical/biotech industry alongside a strong track record of scientific innovation in assay development, screening, and compound mechanism of action studies.
$235,000 - $281,000 a yearExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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We are looking for an innovative, dynamic, entrepreneurial, strategic leader with a wide array of technical expertise including data science, epidemiology, drug development, AI and machine learning as well as an in depth understanding of the pharmaceutical industry, regulatory strategy and evidence generation.
$255,425 - $330,550 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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For all of Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II). and drug substance pilot plant. Well versed in FDA and ICH guidelines relating to registration, quality and compliance concerning drug substance.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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This position requires a comprehensive knowledge of SAS and CDISC standards, project and resource management, regulatory filing experience, and a broad understanding of the pharmaceutical drug development process.
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Strong understanding of the drug development process for early through late-stage programs. Experience on a cross-functional drug development team preferred. 5+ years in product planning preferred, with relevant professional experience in new product planning, market planning, corporate development and/or healthcare strategy consulting considered.
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drug development director jobs in Redwood City, CA
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