Pharmaceuticals

Associate Director of Clinical Pharmacology

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About the job

  • Boston, US
  • Competitive USD / Year

Invenia Group is partnered with an exciting AI-powered clinical-stage biotech company, headquartered in the US, which is seeking an Associate Director of Clinical Pharmacology to oversee and lead the clinical pharmacology team. This position requires a strong scientific background, exceptional leadership skills, and a thorough understanding of the drug development process.

Essential Job Functions:

  • 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 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.

Sound interesting? Apply to find out more.