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Experience of working under own initiative and in planning and prioritizing workloads University or technical college degree or equivalent qualification in relevant sciences such as: Medicine, Pharmacy, Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Health Technology, Toxicology, Physics, Biophysics, Material Science Biomedical Engineering, Mechanical, Electrical or Electronic Engineering, Computer & Software Technology, Human Physiology, Nursing, Quality Management.
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The Senior Scientist functions as a study director to manage the design, execution, analysis, and reporting of pre-clinical discovery research studies across various therapeutic areas. The Senior Scientist is expected to deploy their scientific domain expertise to 1) lead communications with sponsors, 2) interface with business development teams, 3) engage laboratory staff and IACUC, and 4) coordinate with project management and data analysis teammates to manage all aspects of studies from initial pre-clinical study design to final report.
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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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Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.
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Accountable for the design , execute, and critical analysis of nonclinical in vitro and/or in vivo studies conducted in multiple species via collaborative partnerships with study monitors and other partner line program representatives (e.g., toxicology, bioanalytical, operations, etc.
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Understands clinical trial operational complexities from study start up through enrollment, quality assurance, and study readout. Working knowledge of all functional areas of exploratory development, including chemistry/biochemistry, biology, toxicology, CMC, translational medicine, early clinical development, regulatory, etc., and demonstrated ability to successfully and effectively cooperate, collaborate and work across functions.
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Collaborate with other functions, but particularly pharmacology and DMPK/Toxicology to interpret clinical data and establish/refine PK-PD efficacy/safety relationships. Hands on experience with clinical PK/translational/clinical pharmacology studies and an in-depth understanding of study design, data interpretation and how PK studies contribute to the development process.
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Responsible for all areas of preclinical research and development, including generating pharmacology and toxicology data, preclinical trial strategy and design, preparation of the preclinical development plan to support successful INDs, and contribution to regulatory strategy.
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Oversees the QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports and essential clinical study documents.
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Job DescriptionTakeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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Design toxicity studies: coordinate with Preclinical Outsourcing for placement and monitoring of the studies as well as the Bioanalytical and DMPK groups regarding integration of bioanalysis and toxicokinetic aspects into these studies to ensure on-time delivery of key data and study reports.
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About the company:Our client offers preclinical services for drug discovery, focused on the use of nonhuman primates to determine pharmacokinetics, pharmacology and toxicology of small molecules and biologics.
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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master’s degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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Develop and maintain collaborative relationship with colleagues within the department, internal stake holders (i.e., DMPK, toxicology, biology, translational medicine, medical, clinical, biometrics, regulatory, clinical operations, CMC, etc.
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Responsible for conducting toxicology and medical device studies in compliance with GLP/CNAS. As a study pathologist, attend all key activities of preclinical studies regarding pathology, perform macroscopic and microscopic examination, evaluate pathological data and write comprehensive pathology report.
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toxicology study jobs in Cambridge, MA
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