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A thorough understanding of the drug development process from pre-IND through registration and post-registration and a broad understanding of functional areas of drug development, including (preclinical, regulatory, pharmacology, translational medicine, pharmacovigilance, data sciences (data management, biostatistics, programming), and clinical operations is require.
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Lead and shape future clinical development strategy and clinical development plans, working closely with Development and Discovery Program Leads and counterparts in Regulatory, Clinical Development, Clinical Operations, Biostatistics, Clinical Pharmacology, Medical Affairs, Commercial, Non-clinical and Discovery Research for assigned studies.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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We are seeking a hardworking, enthusiastic Associate Scientist / Senior Associate Scientist to support the in vivo Pharmacology group to help build the best-in-class regulatory T cell therapies for autoimmune diseases.
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You will be responsible for: Collaborates with Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials. Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts Contributes to or prepares statistical analysis plans and Data Presentation Plans Collaborates with Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on design of eCRFs Provides statistical guidance on conduct of ongoing trials Collaborates with Statistical Programmers on summary and analysis of trial data.
Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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PhD or PharmD in pharmaceutical sciences, biomedical engineering, clinical pharmacology, or mathematical/statistical sciences with 5 + years of experience with clinical pharmacokinetic and pharmacokinetic- pharmacodynamic data analysis.
$160,000 - $210,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Collaborate with project team members (Project Management, Discovery Biology, Chemistry, Chemistry Manufacturing and Control, Regulatory), and groups within Translational Sciences (Bioanalytical, Toxicology, Translational Pharmacology, and Clinical Pharmacometrics) to generate relevant DMPK data to enable knowledge and data integration to inform and guide target validation, biomarker selection, and candidate advancement.
$129,500 - $191,500 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Medication Safety, Regulatory Affairs, and Quality Assurance. This individual should demonstrate basic knowledge of pharmacology and therapeutics, and understand pharmacy systems of drug distribution and formulary management.
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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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Knowledge of medical terminology, anatomy, physiology, and pharmacology. Must have experience in regulatory issues related to Medicare and other third party payers as is relates to hospital coding and billing.
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Job DescriptionPosition Description:Principal Scientist Translational Pharmacology, NeuroscienceTranslational Medicine at our Research & Development Division is responsible for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modelling colleagues across the organization to translate the benchtop science of preclinical discovery into compounds ready for assessment in large clinical populations.
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This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project management, patient engagement, health economics, legal, finance, medical affairs and commercial.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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We are looking for a Senior Group Director in the Clinical Pharmacology (CP) Group. Anticipates and assess internal and/or external business, scientific and/or regulatory challenges; and is able to recommend sound solutions.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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The Nuvalent pipeline is currently focused on development of precision medicines for oncology targets; therefore, the physician will work closely with scientists in discovery research and translational medicine, as well as non-clinical safety, DMPK/clinical pharmacology, biostatistics, clinical operations, data management, pharmacovigilance, and regulatory affairs.
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Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology. The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development.
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5 years of acute/Inpatient care nursing or 5 years of inpatient coding or CDI experienceOne of the following: CDIS, CDIP, CDEI, CCDSAdditional Requirements:Knowledge of clinical documentation requirements related to regulatory and reimbursement rules and regulations.
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