Modeling & Simulation Scientist Parma

Modeling & Simulation Scientist
Parma
Emilia Romagna, Parma

Team: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location: Parma, IT

About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 31 countries with more than 7, 000 employees (Chiesi Group).

To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas.

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards.

We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors.

Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development Our R&D team represents a fundamental asset for the business.

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.

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 for the implementation of it ensuring delivery of study results within specific timescales and quality and complying with Chiesi SOPs 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.

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 Problem solving 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.

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