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O Coordinate delivery and completion of nonclinical research activities, including preclinical studies, pharmacology, pharmacokinetics, toxicology, bioanalytical, and CMC. o Work with internal stakeholders to identify, evaluate, and select appropriate vendors and CROs for clinical trial services, including packaging, labeling, pharmacokinetics (PK), bioanalysis, and other specialized services.
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Lead a team of scientists and research associates to design and execute preclinical studies aimed at evaluating the pharmacokinetics, pharmacodynamics, efficacy, and safety of LNP-formulated drug candidates.
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Review preclinical study reports, in conjunction with Pharmacokinetics/DMPK and prepare regulatory submission documentation. Solid understanding of drug metabolism, bioanalysis, pharmacokinetics, preclinical pharmacology, PK/PD modeling and clinical study designs.
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Solid understanding of drug development, clinical research, study design, pharmacokinetics, and medical terminology. In addition to its wholly owned clinical assets, Dragonfly has a deep pipeline of wholly owned preclinical candidates discovered using its proprietary platform, as well as productive collaborations with Merck, AbbVie, Gilead and Bristol Myers Squibb in a broad range of disease areas.
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Strong background in quantitative and qualitative research methodologies related to systems biology, pharmacokinetics, and PK/PD. The qualified candidate will apply knowledge and technical expertise to characterize systems biology, pharmacokinetics, and pharmacodynamics-related aspects facilitating research efforts across a diverse portfolio of diseases and therapeutic approaches.
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Moderna’s Bioanalytics group is seeking an Associate Director with strong hands-on experience in ligand-binding assays, including pharmacokinetics (PK), pharmacodynamics (PD), and anti-drug antibody (ADA) assessments, to quantify mRNAs, proteins, and antibodies against therapeutic proteins.
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Working knowledge of skills in PCR methods, LCMS, Flow cytometry are highly desirable. Expertise in Ligand Binding Assay Methods (ELISA, MSD, Gyrolabs, Simoa etc.) Exclusive preferred pricing on Peloton fitness equipment.
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Ph. D./M.S. in clinical pharmacology, pharmacokinetics and metabolism, pharmacometrics, chemical/biomedical engineering, computational biology/chemistry or a related field with 0-5 years' pharmaceutical industry /academic experience.
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Evaluates pharmacokinetics (drug effects) and assesses drug or nutrient interactions. The hospital is also the primary teaching affiliate of the nationally ranked Boston University School of Medicine (BUSM) and a founding partner of Boston HealthNet – an integrated health care delivery systems that includes many community health centers.
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MSc or PhD in Drug Metabolism, Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or related disciplines. Planning, stewardship, analysis, and integration of all in In Vitro and In Vivo ADME, PK, and PK/PD efforts in support of discovery and preclinical development programs.
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Qualifications & Experience: MS or PhD in pharmacokinetics, chemistry, biochemistry, or a related scientific discipline required. Minimum of 3 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical Minimum of 2 years of management experience, including staff management and development Expertise in Bioanalysis and in the design, conduct, and interpretation of in vivo PK studies is Experience with noncompartmental analysis (Phoenix WinNonlin) is required.
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Support in vitro and in vivo validation of brain shuttles, using protein and cell binding assays, and in vivo brain and blood pharmacokinetics and pharmacodynamic (PK/PD) studies in mouse models.
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