Pharmacometrics Scientist

Astrum CRO; Matosinhos; Hybrid; EUR 70,000 - 100,000; Full time

Job summary

Astrum CRO in Portugal seeks a Pharmacometrics Scientist Manager to lead the pharmacometrics function across consultancy, R&D, and early development studies.

You will mentor the team, shape strategy, oversee PK/PD analyses with Phoenix WinNonlin, NONMEM, Monolix, Simcyp, and R, and ensure regulatory compliance. The role emphasizes scientific excellence and client collaboration in a regulated environment.

Qualifications

• Strong pharmacometrics expertise and early drug development experience.
• Experience with FDA/EMA/ICH requirements.
• Leadership experience in a regulated environment.
• Proficient PK/PD modelling and simulation.

Responsibilities

• Define scientific strategy for the pharmacometrics department.
• Oversee PK/PD analyses, modelling, and simulation.
• Mentor and develop a high-performing team.
• Ensure regulatory inspection readiness and CAPA execution.

Skills

PK/PD expertise

Team leadership

Regulatory knowledge

Client communication

Education

MSc or PhD preferred

Health or Life Sciences degree

Tools

Phoenix WinNonlin

NONMEM

Monolix

Simcyp

R

Job description

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.