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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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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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Global Discovery and Development Sciences (GDDS) Boston, part of the US R&D hub, is building a new siRNA Nonclinical Development department with cross-functional scientific expertise, including toxicology, safety pharmacology, PKPD, ADME, outsourcing management, and non-clinical project management.
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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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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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As a leading rare disease biopharmaceutical company, Ultragenyx uses multiple technology modalities including small molecule, biologic, mRNA and AAV gene therapy to make its products. As a leading rare disease biopharmaceutical company, Ultragenyx uses multiple technology modalities including small molecule, biologic, mRNA and AAV gene therapy to make its products.
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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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Analytical Chemistry, Clinical Supply, Biotech, Pharmaceutical Supply Chain, Biologics, Formulation Development, Drug Delivery, Clinical Packaging, Dose Form Manufacturing, Gene Therapy, Vaccine Production, Pharmaceutical, Drug Development, Cell Therapy, Biopharmaceutical, and Innovation.
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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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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 Waltham, MA
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