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    Clinical Pharmacology, Associate Director - Boston, United States - Mason Harding

    Mason Harding
    Mason Harding Boston, United States

    3 weeks ago

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    Description

    Clinical Pharmacology, Associate Director - AI Drug Discovery

    Boston, MA - hybrid

    Mason Harding is proud to be supporting a biotech trailblazer within the field of next-gen artificial intelligence (AI) platforms to accelerate drug discovery and development; significantly cutting down cost and increasing clinical success rates.

    Were now recruiting an experienced Clinical Pharmacologist at Associate Director level in Boston, who reporting directly into the Chief Medical Officer, will take the lead on developing clinical development strategies throughput the early phases of drug development

    Key responsibilities include:

    • Lead and oversee the development of clinical pharmacology strategies at different stages of drug development.
    • Design and contribute to the development of clinical trial protocols, specifically focusing on the clinical pharmacology aspects.
    • Prepare and review the clinical pharmacology sections of IND application documents, including relevant reports.
    • Analyze and interpret safety, efficacy, and pharmacokinetic data from a clinical pharmacology perspective.
    • Develop and utilize quantitative pharmacology tools to support PK/PD analysis and interpretation.
    • Ensure compliance with NMPA/FDA/EMA regulations and guidelines in the design and execution of clinical pharmacology studies.
    • Collaborate with cross-functional teams to provide clinical pharmacology expertise and support to clinical trial design.
    • Provide professional responses to inquiries related to clinical pharmacology from regulatory authorities such as CDE.
    • Manage and coordinate activities with external vendors, including pre-clinical teams and testing CROs.

    Qualifications:

    • Master's or Ph.D. degree in Clinical Pharmacology or related field.
    • Minimum of 5-8 years of experience in clinical pharmacology within the pharmaceutical or biotech industry.
    • Strong knowledge of pharmacokinetics and pharmacodynamics, with experience in drug development processes and regulatory interactions.
    • Proficient in designing and leading clinical pharmacology studies, including PK-related designs for innovative drugs.
    • Familiarity with quantitative pharmacology and bioanalysis techniques.
    • Excellent communication, leadership, and collaboration skills.
    • Strong understanding of NMPA/FDA/EMA regulations and guidelines related to drug metabolism, pharmacokinetics, and clinical trial design.

    Apply with your updated resume today if you have the desired experience

    Keywords: clinical pharmacokinetics, clinical pharmacology, clinical trials, clinical drug development, scientific leadership, associate director, drug discovery, pharmacodynamics, bioanalysis

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