PhD Position in Optimizing Regulatory Framework of Medicine Development and Evaluation
Catholic University of Leuven Department of Pharmaceutical and Pharmacological Sciences
Belgium

The unit Clinical Pharmacology and Pharmacotherapy is looking for a PhD researcher to investigate how the regulatory framework on medicines development and evaluation can be optimized. We are a vibrant unit at the Department of Pharmaceutical and Pharmacological Sciences with a motivated team of researchers involved in several projects on both regulatory and market access level. This project will give you the opportunity to engage with KU Leuven and to collaborate with several external partners such as representatives from the government and pharmaceutical industry, at the national, European and international level.

Project

The coronavirus pandemia has impacted scientific research and triggered a rethinking of the regulatory pathways for drug development and evaluation. Clear dialogues between drug developers in the profit and non-profit context, regulatory representatives (at the European Medicines Agency - EMA - and national authorities) as well as health technology assessment (HTA) bodies and payers are indispensable for adequate access to medicines by patients. In this project, we investigate how the design of clinical trials can be informed as much as possible by all stakeholder's needs, how the long-term interaction between regulatory agencies and national (reimbursement) authorities can be sustained, and how pathways on early access can be aligned at the regulatory and market access level. We want to explore how the collaboration between regulatory agencies and national HTA/payers on sharing information can be improved. In a learning healthcare system, it is important to fill in gaps between catalysing innovative R&D and ensuring such innovative medicines become available and used by health care practitioners (HCP) in clinical practice.  

To this end, the PhD student will 1) undertake research to explore the reasons for divergences on assessments regarding risks and benefits at the European and national level; 2) address pathways towards convergence between regulatory and hTA/payer level assessments, early in procedures (sharing of information during the assessment); 3) explore how possibilities to approximate authorisation procedures (in time, content, format) could foster convergence; 4) approach difficult underlying issues such as the different basis of HTAs and EMA work/endpoints/evidence base.

The PhD project will require a highly collaborative approach to formulate solutions acceptable to all relevant stakeholders. Therefore, the PhD student will have to build durable relationships with regulatory and governmental agencies, pharmaceutical industry, academia, patient organisations and healthcare providers. The research will include quantitative studies (literature reviews, surveys, analysis of data) and qualitative studies (semi-structured interviews, focus group discussions, expert panels, workshops).
 
Description of the function:
- You perform research in the described research domain. You are involved in the design, set-up and execution of the research, and you report on the results in scientific publications. This research has the intention to lead to a PhD degree.
- You are motivated to collaborate with external stakeholders to formulate widely supported solutions.
- You follow the 'patient related and public health research' programme of the Doctoral School of Biomedical Sciences at KU Leuven. 
- You coach master students carrying out their master thesis.

Profile

Master in pharmaceutical sciences, master in drug development, master in biomedical sciences, master in medicine, master in bioengineering, master in law, master in bioethics, or master in social sciences with outspoken interest in regulatory sciences, market access and/or health economics. Candidates with a Master's degree in another field may apply if they can demonstrate their expertise and interest in regulatory sciences, market access and/or health economics.


You will engage yourself with enthusiasm and perseverance to a four-year research project. You are ambitious, dynamic, flexible and take an open attitude towards problems and evolutions. You are directed towards innovation and patient access. You are able to work independently and take decisions. You have excellent social and communication skills to deal with all stakeholders in this field. You are able to work in an international multidisciplinary team and cooperate with other team members. You can speak fluently Dutch (French is a plus) and have good written and oral knowledge of English. You have good didactic skills and you can coach and motivate other persons.

Offer

A full time position within a highly motivated research group with relevant experience and expertise. For this job, a contract of 1 year is offered that, after a positive evaluation, can be extended yearly to a period of 4 years.

Interested?

For more information please contact Prof. dr. Isabelle Huys, tel.: +32 16 33 04 09, mail: isabelle.huys@kuleuven.be.

Your solicitation is expected before June 27st 2021. Interviews take place between June 28th and July 7th 2021.
If later, contact prof. Isabelle Huys. 
 
You can apply for this job no later than June 27, 2021 via the
KU Leuven seeks to foster an environment where all talents can flourish, regardless of gender, age, cultural background, nationality or impairments. If you have any questions relating to accessibility or support, please contact us at diversiteit.HR@kuleuven.be.
  • Employment percentage: Voltijds
  • Location: Leuven
  • Apply before: June 27, 2021
  • Tags: Farmaceutische en Farmacologische Wetenschappen


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