This PhD position is part of research project NANOSPRESSO-NL (funded by the Dutch Research Council NWA-ORC). This project aims to research, develop, and implement a technology for decentralized and small-scale production of high-quality and affordable nucleic acid nanomedicines to improve the quality of care for patients with (ultra)orphan diseases. These diseases affect many Europeans, despite the fact that the number of people suffering from any individual rare disease is small. The vast majority of orphan diseases are genetic, and their cause can be addressed by compensating for the defective gene.

The therapeutic solution proposed by NANOSPRESSO-NL combines multiple technical innovations: nucleic acid (e.g. mRNA) as the active substance, lipid nanoparticles as the formulation, and decentralised manufacturing using microfluidic cartridges. Each of these innovations challenges the existing framework for authorisation of medicinal products in Europe.

Nucleic acid therapies, such as administering mRNA for the defective or missing protein, have proven to be effective cures for many rare diseases. Nucleic acid therapeutics are revolutionizing medicine and are uniquely qualified for production in local hospital pharmacies to address the current mismatch between personalized therapeutic strategies and industrial centralized large-scale manufacture of medicines.

This PhD position will focus on the regulatory challenges of the innovation. The objectives of the project are:

• To map the development and regulatory landscape of nucleic acid therapies in Europe.
• To analyse the dynamic interaction between innovation and regulation of nucleic acid therapies in Europe.
• To identify facilitators and barriers for approval of nucleic acid therapies in Europe.

Methods applied to study these questions include comparative document analyses, quantitative descriptive and association studies and complex systems analyses.

This is a full-time research position for 4 years. Besides that, you will also be involved in teaching activities within the division (approximately 10% of your time).

You will work closely with a post- doctoral researcher for whom we are simultaneously recruiting. For more information on this position, please visit our website.

Are you excited to be part of this promising research project? Then join us. As this position requires collaboration with colleagues from different academic and cultural backgrounds, it is important that you can work in multidisciplinary teams.

We are looking for a candidate who meets the following criteria:

• a MSc in pharmaceutical or (bio)medical sciences, innovation studies, public health, or another relevant field;
• the ability and enthusiasm to learn quantitative and qualitative methods within Drug Regulatory Science;
• an interest in cross-disciplinary work within Drug Regulatory Science;
• good communication skills in English, both oral and written;
• the ability to work independently and be self-reflective. 

We consider it a plus if you:

• quickly understand complex systems (i.e. international health policies);
• have practical experience with data analyses, qualitative (e.g. NVivo) or quantitative (e.g. R, SAS, or SPSS)
• are able to work with different types of stakeholders such as drug developers, healthcare decision-makers from public institutes or governments;
• like to work in a dynamic environment on multiple projects simultaneously;
• take initiative and responsibility for your projects;
• like to teach graduate students and supervise bachelor and master research projects within the pharmaceutical policy domain.

We offer:

• A full-time position for 4 years;
• A full-time gross salary starting at €2,541 and increasing to €3,247 (scale P Collective Labour Agreement Dutch Universities);
• 8% holiday bonus and 8.3% end-of-year bonus;
• A pension scheme, partially paid parental leave, and flexible employment conditions based on the Collective Labour Agreement Dutch Universities;
• The research group will provide you with the necessary support on all aspects of the project.

In addition to the employment conditions from the CAO for Dutch Universities, Utrecht University has a number of its own arrangements. These include agreements on professional development, leave arrangements and sports. We also give you the opportunity to expand your terms of employment through the Employment Conditions Selection Model. This is how we encourage you to grow.

For more information, please visit working at the Faculty of Science. 

A better future for everyone. This ambition motivates our scientists in executing their leading research and inspiring teaching. At Utrecht University, the various disciplines collaborate intensively towards major strategic themes. Our focus is on Dynamics of Youth, Institutions for Open Societies, Life Sciences and Sustainability.

At the Faculty of Science there are 6 departments to make a fundamental connection with: Biology, Chemistry, Information and Computing Sciences, Mathematics, Pharmaceutical Sciences and Physics. Each of these is made up of distinct institutes that work together to focus on answering some of humanity’s most pressing challenges. More fundamental still are the individual research groups – the building blocks of our ambitious scientific projects.

You will be employed within the Division of Pharmacoepidemiology and Clinical Pharmacology, which is one of the five divisions of the Utrecht Institute for Pharmaceutical Sciences (UIPS). This is the research institute of the Department of Pharmaceutical Sciences of Utrecht University.

The Division of Pharmacoepidemiology and Clinical Pharmacology consists of a multidisciplinary team of young and internationally oriented researchers. The research programme is directed at several epidemiological, therapeutic, and policy aspects of chronic drug use with a focus on advanced affordable biomolecular and cellular therapies. The PhD position falls under the Centre for Pharmaceutical Policy & Regulation (one of the three Centres of the Division). This Centre for Pharmaceutical Policy & Regulation is embedded in the Division of Pharmacoepidemiology & Clinical Pharmacology. The Centre aims at developing new methods for independent policy and regulatory research, for evidence-based policy scenarios, bridging population level to individualized medicine, and for regulatory and health technology assessment (HTA) decision-making on (bio)pharmaceuticals throughout the world. The Centre has been designated as World Health Organization Collaborating Centre.