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Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.
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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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Work with key cross-functional stakeholders to manage the content of all documents including, but not limited to: Clinical Development, Drug Safety, Pharmacovigilance, Regulatory, Clinical Operations, Data Management, Biometrics, Clinical Pharmacology, CMC/Manufacturing, Legal, Investor Relations, and Corporate Strategy.
$240,000 - $275,000 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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They will offer expertise in analyzing pharmacokinetics, absorption, distribution, elimination profiles, dose selection rationale, drug/food interaction potential, and QT prolongation potential.
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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.
$185,000 - $226,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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We seek outstanding candidates with teaching experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs, clinical and medical affairs, quality management, project management, finance, business operations, research and development, biometrics, health economics and outcomes research or manufacturing.
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Experience with advanced knowledge of psychometrics, econometrics, and biometrics such as validation of health measurement scales, longitudinal data analysis, missing data methods, multiple comparisons techniques, cost-effectiveness analysis, generalized linear models, meta-analysis, real-world data analysis, and conjoint analysis.
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Medical expert responsible for the development of clinical research strategies and independent direction of Phase 1-3 clinical studies while working with cross-functional project teams (clinical project managers, research, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC), creation and execution of clinical development plans, and the development of strategies that will ultimately lead to approvals of Neurocrine's products.
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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.
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This position works very closely with external vendors, HCPs, as well as multiple Iovance teams: Commercial, Medical Affairs, Regulatory, Safety, Clinical, Biometrics, Quality, Legal, Quality, Supply Chain & Logistics and Manufacturing.
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Experience in Rare Disease Drug Development and familiarity with gene and/or cell therapy preferred. Reporting to the VP of Biometrics, the Director/Sr. Director, Clinical Data Management is responsible for all clinical data management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data.
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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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Understands the life sciences industry (e.g., CROs, pharma/biotech, medical device), scientific & clinical data/terminology, and the drug development process. This position is primarily remote, non-office based, with the expectation to travel up to 50.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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We are seeking a stellar biostatistician to join our rapidly growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. PhD in Biostatistics or a related field with a minimum of 5 years of relevant experience in pharmaceutical or biotechnology drug development.
$130,000 - $180,000ExpandApply NowActive JobUpdated Today
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