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Director of Toxicology leads nonclinical safety within Preclinical Development and is responsible for coordinating nonclinical safety to adequately support BlueRock programs from research through development stages.
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Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively inform the conduct of safety surveillance Ability to thrive in a fast-paced environment while providing appropriate attention to detail.
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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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They have the comprehensive responsibility for designing and executing the early clinical drug development phase together with a project team from researcher, biomarkers, biostatistics, modelling & simulation, toxicology, technical experts and the clinical trial teams.
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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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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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Expert knowledge of environmental science, industrial hygiene, exposure assessment, toxicology, epidemiology, human health risk assessment, and related subject matter. Expert knowledge of environmental science, industrial hygiene, exposure assessment, toxicology, epidemiology, human health risk assessment, and related subject matter.
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Support DMPK needs for clinical stage programs through close collaboration with Clinical Pharmacology and Toxicology. Work closely with DMPK CROs to design, coordinate, monitor and manage external ADME and PK studies.
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Strong understanding of all aspects of compound optimization including synthetic chemistry, structure-based drug design, ligand-based drug design, pharmacokinetics, pharmacology, and toxicology.
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By clicking the Apply button, I understand that my employment application process with Takeda will commence and that. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to 100% remote work allowed from any location in the U.S.
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Based employees are also eligible to receive, per calendar year, up to. state or local minimum wage requirements for the job location. in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and.
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Possesses a thorough knowledge and understanding of clinical development in various therapeutic areas, the impact of pharmacologic agents on humans, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans.
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Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK.
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Coordinate efforts and collaborate with internal stakeholders (i.e., regulatory, translational, biostatistics, pharmacology/toxicology) to allow efficient execution of clinical studies. Broad and solid understanding of functional areas of drug development, including but not limited to the following: preclinical discovery and mechanisms of action, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management.
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The candidate will have the opportunity to lead multi-disciplinary drug discovery and preclinical teams as targets progress and will be expected to work seamlessly with colleagues across discovery research, chemistry, preclinical pharmacology, toxicology and analytical development.
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toxicology job in Lexington, MA
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