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This position will allow a wealth of opportunities for research collaborations within the Department of Pediatrics, with Emory's NCI-designated cancer center (Winship Cancer Institute), as well as with Emory basic science departments, the Rollins School of Public Health, the Centers for Disease Control and Prevention, Morehouse School of Medicine, and Georgia Institute of Technology.
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Founded in 2015, the company has built a portfolio of 30+ 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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And minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility.
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Support the oversight of drug safety/pharmacovigilance service providers to ensure the collection, processing, and reporting of adverse events reports in compliance with global regulatory requirements.
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Build QSP models integrating biological, pharmacological, and physiological data to support drug development at all stages, from preclinical research to clinical trials and beyond, aiding in dose optimization, biomarker identification, safety and efficacy assessment, drug development decision-making, etc.
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Targeting 10 years of experience as lead statistician on clinical trials in the pharmaceutical industry with significant experience in rare disease drug development. Maintain thorough understanding of current regulatory guidelines and requirements relevant to rare disease drug development.
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The Center's research efforts focus on two main areas: 1) discovery and validation of biomarkers for disease prediction and diagnosis, 2) pharmacomics and drug discovery for personalized medicine.
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Mandatory drug testing prior to employment and will be subject to random, unannounced drug and/or alcohol testing during employment." Must be a Certified Juvenile Probation Officer, within six months of hire, and a Licensed Chemical Dependency Counselor (LCDC) preferred.
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The Clinical Trials Unit currently works on several interventional and observational studies with subjects that have subjective complaints of memory loss, Mild Cognitive Impairment (MCI), Early Onset Alzheimer's Disease (EOAD), mild to moderate Alzheimer's Disease (AD), Frontotemporal Dementia (FTD), and semantic variant Primary Progressive Aphasia (svPPA.
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Head, Patient Advocacy | European commercial-stage rare disease biotech. ED, Global Commercial Strategy Franchise Head | Top rare disease Boston pharma. VP, Head of Global Drug Safety & PV | Chinese oncology biotech.
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This Associate Director will work with scientists within QP2 by applying one or more of the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and thereby strengthening our pharmacometric capabilities on a continuous basis in decision making and driving pipeline impact.
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Knowledge of drug development, pharmacokinetics and pharmacology principles required. The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions.
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The Associate Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author strategic documents. (a Ph. D. or equivalent degree with a minimum 3 years of experience) OR (a PharmD or equivalent degree with at least 5 years of experience) OR (an MS or equivalent degree with at least 7 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
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Framing critical drug development questions for optimizing model-informed development. Responsible for developing and executing population pharmacokinetic models, PK/PD models, ER models, MBMA, CTS, disease progression models, and other pharmacometric analyses.
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Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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disease drug jobs Title: fellow Company: Emory University
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