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Vertex San Diego Drug Metabolism and Pharmacokinetics (DMPK) team is seeking a highly motivated, experienced scientist and leader Senior Director level to help advance discovery and development of transformational therapies for serious unmet medical needs.
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We are seeking an experienced translational modeler eager to accelerate drug discovery & development by facilitating rigorous decision making with modeling & simulation, from target identification to first-in-human studies and beyond.
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A demonstrable track record of leading, understanding and hands-on experience of drug metabolism and pharmacokinetics, both in vitro and in vivo studies, human PK prediction, DDI prediction and mechanistic understanding to support late-stage programs.
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CTM, Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF. Participate in team meetings and collaborate with other functional groups within the company (e.g., Clinical Development, Pharmacokinetics, Quantitative Sciences, Regulatory, QA, Finance, Legal, etc.
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Clinical pharmacokinetics, clinical pharmacology, clinical trials, clinical drug development, scientific leadership, associate director, drug discovery, pharmacodynamics, bioanalysis.
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Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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Establish and continuously optimize overall BSM processes across PrM. Support development of a strategy, including QCP, TS and CDx, and process to construct and execute plan document such as Pharmacokinetics (PK), Anti-Drug Antibody (ADA) and biomarker analysis plans, which aid in the construction of clinical development plans, clinical protocols, and in the submission of certain regulatory documents.
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Provide oversight to the development of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include population pharmacokinetics, pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling, model-based meta-analysis, and decision analysis.
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A PhD with at least 5 years of experience in biopharmaceutics, drug absorption/pharmacokinetics, PBPK modeling, in-silico platforms, and/or drug delivery for small molecules and/or biologics.
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Sponsor-InvestigatorsIn collaboration with the CDMA TA personnel and the Director, Scientific Communications, assists Sponsor-investigators by providing responses to requests for medical/scientific information, in accordance with process defined methods, necessary for the investigator's development of their proposal.
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Independently designing and synthesizing drug-like molecules utilizing medicinal chemistry knowledge and an understanding of ADME, pharmacokinetics, optimal physicochemical properties, and AI/ML predictive tools.
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Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical and biologics services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
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Our aim is to find the right dose of the right drug for the right patient, embodying the model-informed drug discovery and development (MIDD) paradigm. Consider joining Team Lilly in Indianapolis to contribute to Lilly's drug discovery and development efforts.
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12+ years of experience in the biopharma industry in non-clinical development (toxicology, pharmacology, pharmacokinetics, bioanalytical sciences, or related discipline) Strong understanding of science and drug development, with specific expertise in nonclinical study design, preclinical CROs, data management systems, nonclinical study procedures, and statistical analysis methods.
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FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immuno-oncology product candidates for the treatment of solid tumors. Develop and implement new clinical pharmacology tools and technologies to drive efficient drug development.
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