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The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
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Oversee the execution of histopathology strategies and deliver biomarker results to internal and external stakeholders while working collaboratively with Translational Biomarker Leads, Biology, Clinical Science, Biometrics, Bioinformatics, Clinical/Biomarker Operations, and others.
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The IT Director for Tech Ops GxP Systems will play a key leadership and contributor role in supporting and driving all IT GxP programs and initiatives within ArsenalBio. This role will design, develop and manage all cross-functional deliverables and stakeholder commitments required to support and maintain the IT Manufacturing systems including ERP, MES, Inventory, CT orchestration systems and automated CGT equipment vendors.
$194,300 - $238,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage. 5+ years of related experience, including 3 years of relevant industry experience, preferably in data services (data management and biometrics) or a clinical research environment.
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Additionally, the role involves representing the organization in interactions with regulatory agencies, fostering a culture of excellence and continuous improvement within the Global Biometrics and Data Sciences, and serving as a thought leader in the field of real-world evidence.
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This is a unique opportunity for an experienced biostatistician/ stat programmer people leader to join the Scientific Insights & Analytics group (Biometrics & Scientific Communications) in the Surgical Structural Heart Valve business unit to support various global medical and clinical activities.
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Collaborate cross-functionally with other departments, including Clinical, Regulatory, Translational Science, Biometrics, Clinical Operation and Pharmacovigilance. We are looking for an Associate Director in Clinical Pharmacology who will be a key member of our multidisciplinary drug development teams.
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Reporting to the VP of Biometrics, you will support both early and late phase oncology products, interact with regulatory officials on all statistical related matters, oversee development plans, and provide strategies for clinical study design, endpoint selection, sample size calculations, statistical analysis plans (SAP) and more.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Senior Director of Real-World Evidence Biostatistics plays a pivotal role in leading and overseeing the strategic direction and execution of statistical and real-world evidence initiatives within the organization.
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Director, Biostatistics Operations (Scientific Insights & Analytics) - Surgical Structural Heart. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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It is made up of outstanding professionals in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs.
Starting at $250Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Broad and solid understanding of functional areas of drug development, including but not limited to the following: preclinical discovery and mechanisms of action, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management.
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The ideal candidate must be able to lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on innovative biostatistician. Experience in managing a Biostatistics or Biometrics team and overall resource planning.
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As the Associate Director, Clinical Quality Assurance (CQA), you are a key member of the Clinical Quality team maintaining representing Clinical QA in cross functional setting, and advising Cytokinetics Clinical Operations, Biometrics, Drug Safety and Pharmacovigilance teams on GCP matters.
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We are currently looking to strengthen our Business Development team through the recruitment of a Director, Business Development to support our business development activities. This position is primarily remote, non-office based, with the expectation to travel up to 50.
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