Demo

Director of Pharmacometrics

EPM Scientific - Phaidon International
MA Full Time
POSTED ON 2/24/2025
AVAILABLE BEFORE 5/19/2025

The Director of Pharmacometrics will play a crucial role in optimizing dosing regimens, ensuring regulatory compliance, and contributing to the overall success of therapeutic projects.

Key Responsibilities :

  • Lead and oversee the development and application of pharmacometric models to support drug development and regulatory submissions.
  • Collaborate with clinical pharmacology, biostatistics, and other interdisciplinary teams to inform clinical trial designs and data analysis.
  • Develop and implement model-based strategies to optimize dosing regimens and therapeutic outcomes.
  • Ensure the accuracy and quality of pharmacometric analyses and reports.
  • Mentor and provide scientific guidance to a team of pharmacometricians and other scientific staff.
  • Engage with regulatory agencies and prepare regulatory submission documents related to pharmacometric analyses.
  • Stay abreast of the latest developments in pharmacometrics and incorporate new methodologies and technologies as appropriate.
  • Present findings and strategies to senior management and cross-functional teams.
  • Develop and maintain standard operating procedures (SOPs) for pharmacometric activities.

Qualifications :

  • PhD in pharmacometrics, pharmaceutical sciences, pharmacokinetics, or a related field.
  • Extensive experience with non-linear mixed effects modeling.
  • Proven track record of successful regulatory submissions involving pharmacometric analyses.
  • Excellent leadership and mentoring skills.
  • Strong publication record in peer-reviewed journals.
  • Experience with software tools like NONMEM, Monolix, or similar platforms.
  • Exceptional communication and collaboration skills.
  • Preferred Skills :

  • Strong analytical and problem-solving abilities.
  • Ability to work effectively in a fast-paced, dynamic environment.
  • Experience in managing multiple projects simultaneously.
  • Familiarity with the latest advancements in pharmacometric methodologies and technologies.
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