Pharmacometrics Scientist
ASTRUM · Matosinhos e Leça da Palmeira, Portugal
No Portuguese requiredPosted 4 days ago
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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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