(Associate) Director of Clinical Pharmacology

3 weeks ago


Boston, United States Invenia Group Full time

Invenia Group is partnered with an exciting AI powered clinical stage biotech company, headquartered in the US, who are 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.


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