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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.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Beneficial to have an understanding of other functions such as Clinical Operations, Biometrics, and Drug Safety. ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Director, IT GxP Systems to work onsite based in our Hayward office.
$194,300 - $238,000 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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. Knowledge of and experience in selling biometrics, regulatory submissions, and regulatory operations will be a distinct advantage.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Interface effectively with other Innovative Medicines R&D functions and other departments, including Clinical Operations and Biometrics in design and conduct of the clinical programs.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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The Development Business Operations Associate II is responsible for the assistance in the clinical outsourcing of global Phase I-IV clinical trials in support of ancillary vendors, which may include clinical pharmacology, RTSM, eCOA, medical imaging and biometrics functions.
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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. You should be familiar with current scientific best practice and regulatory guidance in clinical pharmacology, pharmacometrics, pharmacokinetics and drug metabolism.
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The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
$155,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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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 17 days ago - UpvoteDownvoteShare Job
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Provides advanced technical statistical programming leadership to the Statistical Programming function within Biometrics and be a technical resource for statistical programmers. Advanced SAS programming skills and expertise in the development and implementation of statistical programming SOPs and processes in a clinical environment.
$125,700 - $182,250 a yearFull-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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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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Masters in Statistics or Biostatistics Plus 8+ years of previous related experience in analytical experience with clinical trials /clinical research. Expert understanding of clinical trial design, including Bayesian and adaptive designs, while identifying applications of functional knowledge and methodologies to resolve complex problems.
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Our capabilities include Medical Exams & Travel program management; 24/7 Incident Intervention telehealth triage; Onsite Services & Clinics; Consulting Medical Directors; Clinical Accommodation and Leave Management support; and a full suite of COVID-19 interventions.
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