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Pharmacometrics Scientist

Descrição do Emprego - Pharmacometrics Scientist

We are seeking a Pharmacometrics Scientist Manager to lead our Pharmacometrics function and provide PK/PD scientific leadership across consultancy services, R&D, and Phase I/II studies. In this role, you will develop and mentor the team, shape departmental strategy, ensure regulatory compliance, and foster a culture of scientific excellence and continuous improvement.

Key Responsibilities

  • Define the department’s scientific strategy and provide PK/PD expertise to project teams and sponsors.
  • Oversee PK/PD analyses, modelling, and simulation, including contributions to protocols, statistical analysis plans (SAPs), and study reports.
  • Lead and develop the team while managing workloads and resource allocation.
  • Ensure regulatory compliance, inspection readiness, and timely implementation of corrective and preventive actions (CAPAs).
  • Support business development and promote continuous process improvement.

Requirements

  • Degree in Health or Life Sciences; an MSc or PhD is preferred.
  • Extensive expertise in pharmacometrics and early drug development, with knowledge of FDA, EMA, and ICH requirements.
  • Hands-on experience with PK/PD software such as Phoenix WinNonlin, NONMEM, Monolix, Simcyp, and R.
  • Proven experience leading teams in a regulated environment.
  • Strategic, client-focused mindset with excellent communication skills.
  • Fluency in English.


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