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A minimum of 10 years of related pharmaceutical or biotechnology industry experience in clinical pharmacology, population PK, PK-PD modeling, DMPK, and/or pharmacometrics and a proven track record advancing programs through the drug development process, from discovery through IND to registration, informing data driven decisions on dose and schedule, making tough judgement calls where needed.
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Proclinical Staffing is seeking a Director Scientific Communications to join a global biopharmaceutical company. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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Contributes to the design of early and late-stage clinical trials (FIH to Submission) including: Non-compartmental analysis for human PK, PD, BM and safety data (including ADA) to guide decision making during dose escalation and dose-response clinical studies Clinical pharmacology and biopharmaceutical aspects for designing key elements trials.
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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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PhD in pharmacology, pharmacokinetics, pharmacometrics, PharmD, or other professional doctorate in pharmaceutical sciences or a related scientific discipline with minimum 2 years of post-doctoral experience and/or relevant industry experience.
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The Program Leader will lead a cross-functional team across clinical operations, regulatory affairs, clinical pharmacology, biomarkers, CMC, non-clinical, and medical to deliver against the program strategy.
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Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.
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This role will partner with the Biopharmaceutical Sciences CGT team on a variety of strategic, operational, and organizational matters across three pillars: CMC Project Leadership, Project Management and leadership team (LT) operations.
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Senior Analyst Bio: The Senior Analyst has over a decade of professional experience with a focus on biopharmaceutical, including biotechnology equity research analyst at Jefferies, strategy consultant at a leading consulting firm, investment profession at private equity and venture capital funds, and marketing/sales management at a major medical device company.
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Scope of ResponsibilityWill serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives.
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PhD or PharmD with relevant expertise in clinical pharmacology or pharmaceutical science is required. Develop and oversee implementation of clinical pharmacology studies from protocol development to final study reporting, in collaboration with cross-functional study team members, including Clinical Operations, Biometrics and Regulatory Affairs, as well as CRO partners.
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Dragonfly Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing therapies that use its novel multispecific antibody technology to harness the body's immune system to bring breakthrough treatments to patients.
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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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The professional registered nurse is knowledgeable of current trends in healthcare including but not limited to advances in technology, pharmacology, treatment care modalities, quality and patient safety.
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Ph. D. in statistics (or closely related field e.g. medical statistics, biometrics, medical informatics, biopharmaceutical statistics) with 2 years biopharmaceutical industry experience as a biostatistician or a Master's degree in a relevant statistics field and 4 years industry experience (as a biostatistician) in Biotech, Pharma, Regulatory agencies, or Clinical Research Organizations (title commensurate with experience.
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pharmacology biopharmaceutical jobs in Boston, MA
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