Postdoc in Drug Regulatory Science (0.8-1.0 FTE)
Postdoc in Drug Regulatory Science (0.8-1.0 FTE)
You cannot apply for this job anymore (deadline was 28 May 2023).
Browse the current job offers or choose an item in the top navigation above.
Job description
Novel therapeutics may face difficulties in moving from bench to bedside. Unique characteristics of novel therapeutics and the rapid pace of scientific advancement can make it difficult for these therapies to fit into existing regulatory frameworks, and regulatory agencies (such as the European Medicines Agency) must continually adapt their guidelines and standards to ensure the safety and efficacy of these new treatments.
The regulatory system for medicines is intended to protect public health by ensuring that only medicines of sufficient quality, safety, and efficacy enter the market. At the same time the system facilitates patient access to needed therapies without unnecessary delay. It strives to achieve these goals via a large set of individual regulatory tools. For policy-making in general, and especially in the health care sector, regulatory decisions need to be fully transparent, rest on relevant reasoning, and be adaptable in light of new evidence. Therefore, the efficiency of the elements in the regulatory toolbox, as well as any unintended effects of the tools, need to be determined.
We offer an exciting post-doctoral position in our international cross-disciplinary research environment at the Utrecht Centre for Pharmaceutical Policy and Regulation. You will contribute to a number of externally funded projects and take the lead in setting up, carrying out and reporting of individual regulatory science studies. Supervising MSc students or PhD candidates may also be part of this.
Topics you will be working on may include:
- Identifying barriers and facilitators for authorisation of nuleic acid therapies.
- Regulatory challenges of decentralised manufacturing of lipid nanoparticle therapies or 3D printed medicines.
- Development and implementation of an infrastructure for real-time analytics of medicine regulatory processes.
- Development of complex science methods to study the dynamic interaction between technological innovations and regulatory changes.
- Assessment of the regulatory acceptance of and regulatory readiness for novel platform techniques (e.g. organoids, AI) applied in oncology drug development.
The position also involves teaching activities within the division (approximately 10% of your time) . Besides that, you will be actively involved in outreach activities of the group to create visibility and impact for society.
One of the projects you will work on is the NANOSPRESSO-NL project (funded by the Dutch Research Council NWA-ORC). This project aims to research, develop, and implement a technology for decentralised and small-scale production of high-quality and affordable nucleic acid nanomedicines to improve the quality of care for patients with (ultra)orphan diseases. For this project, we are simultaneously recruiting a PhD candidate with whom you will work intensively. More information about this position can be found on our website.
Specifications
- 30—40 hours per week
- €2960—€4670 per month
- Utrecht View on Google Maps
:fill(white)/logos/uu-en-wide.jpg)
Utrecht University
Requirements
In this position you will collaborate with colleagues from different academic and cultural backgrounds, it is therefore important that you work well in multidisciplinary international teams.
We are looking for a colleague who meets the following criteria:
- a PhD in pharmaceutical or (bio)medical sciences, innovation studies, public health, or other relevant field;
- scientific creativity and productivity, as evident in recent publications in (international) peer-reviewed journals;
- strong analytical skills and practical experience with data analyses, qualitative (e.g. NVivo) or quantitative (e.g. R, SAS, or SPSS) as well as the ability and enthusiasm to learn complementary methods 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:
- have experience in supervising master research projects within the pharmaceutical policy domain;
- have experience in studying the drug regulatory system;
- have experience in cross-disciplinary research;
- have worked with different types of stakeholders such as drug developers, healthcare decision-makers from public institutes or governments.
Conditions of employment
We offer:
- a position for 2 years (0.8-1.0 FTE) with the possibility to extend to a total maximum of 4 years;
- a full-time gross salary, depending on previous qualifications and experience, ranging between €2,960 and €4,670 per month (scale 10 according to the Collective Labour Agreement Dutch Universities (cao));
- 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 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.
Employer
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 WHO Collaborating Centre.
