Modeling & Simulation Scientist

Who we are looking for

Purpose

The candidate will have to contribute to the definition of the Model Informed Drug Development strategy across projects on a variety of therapeutic indications and data types in order to optimize future studies and will be responsible to the implementation of it ensuring delivery of study results within specific timescales and quality and complying with Chiesi SO Ps and standards and Chiesi Group objectives.

In particular, the Modelling and Simulation scientist Expert provides specialized advanced modelling skills to multiple projects and works within a dedicated team along with an external network of experts to support the delivery of analyses, enhance project impact, develop and apply quantitative methodologies and solutions.

Main Responsibilities

• Leads Pharmacometrics activities including PK, PK/PD and PB-PK modeling, simulation and reporting activities for multiple projects.

• Assists Clinical Pharmacology senior management in the selection of action plans that best meets drug development business objectives; contribute to MIDD strategy for global biopharmaceutical development.

• Perform pharmacometric activities (hands on) within clinical development programmes, through high-quality work (using Nonmem and all relevant software)

• Establish and maintain strategic CRO interactions manage the internal and external communications, publications plan.

• Author, review or approve pharmacometrics reports and related sections of regulatory documents; participate in meetings with clients and regulatory agencies if requested.

Experience Required

At least 3 years in similar roles.

Education

Scientific degree, Doctorate degree in pharmacometrics, clinical pharmacology, pharmaceutical sciences,

medicine, statistics, chemical engineering, or related field.

Languages

English Fluent



Technical Skills

Demonstrated leadership competencies in Pharmacometrics, biostatistics, and PK/PD activities from planning, implementation through completion across multiple projects

Experienced in PK/PD and population PK approaches of data analysis. Experience with population PK and PK/PD modeling software (NONMEM, Monolix, R, MATLAB etc. )



Soft Skills


• Communication skills



• Problem solving



• Team working



• Learning agility



What we offer


You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.