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Stakeholder Engagement & Regulatory Frameworks in Patient-Centred Evidence
KU LeuvenLeuven, BE7 dagen geleden
FunctieomschrijvingMaster 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 - Candidates with a Master’s degree in another field may apply if they can demonstrate their expertise and interest in the fields related to the projects- You will engage yourself with enthusiasm and perseverance to a 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 have good written and oral knowledge of English. - You have good didactic skills and you can coach and motivate other persons.Key Areas of WorkUNIFIED (Unifying Framework for Patient-centred Clinical-study Endpoints derived from Digital Health Technologies)UNIFIED is a project that aims to create a robust, evidence-based framework for integrating patient-centred data - such as patient preferences, clinical outcome assessments, and digital health technology (DHT)-derived measures - into drug development and regulatory decision-making. KU Leuven leads Task 3.1, which analyses how regulators, HTA bodies, and payers currently use such data to ensure that the new framework is aligned with real-world decision processes. You will : - conduct a targeted literature review and document analysis to map existing regulatory and HTA frameworks used by end users (e.g. EMA, FDA, HTA agencies, payers, industry). - This includes analyzing public assessment reports and HTA evaluations to understand how patient experience data and digital endpoints are currently used. The output will inform the structure and practical alignment of the UNIFIED Framework.PERIFORMANCE (Public Engagement in Research Infrastructures for Mission Cancer : Managing Complexity of Emerging Technologies) PERIFORMANCE supports the EU’s Mission on Cancer by identifying and improving stakeholder engagement practices in cancer research biobanking. It focuses on ethical, legal, and societal implications (ELSI), with KU Leuven leading two Work Packages, where you will : - map current engagement practices and stakeholder preferences in cancer research biobanking through literature reviews, interviews, and Discrete Choice Experiment, - conduct legal analysis in the context of recent regulations like the European Health Data Space (EHDS) The goal is to provide policy recommendations that support inclusive, transparent, and legally sound engagement strategies for cancer research biobanking across Europe.The project has a special focus on biobanking, and the project coordinator is the Biobanking and BioMolecular resources Research Infrastructure (BBMRI). Other responsibilitiesYou will : - Be actively involved in the design, set-up, and execution of research activities, with the aim of obtaining a PhD degree.- Conduct literature reviews, document analyses, and comparative legal reviews.- Design, carry out, and analyse qualitative interviews, focus groups, and a Discrete Choice Experiment (DCE).- Liaise with international project partners and coordinate ethics approvals.- Draft project deliverables, scientific publications, and conference abstracts; present findings to academic and non-academic stakeholders.- Collaborate with external stakeholders - Supervise and mentor students working on topics related to your researchThe unit Clinical Pharmacology and Pharmacotherapy at KU Leuven invites applications for a PhD fellowship that bridges two EU-funded research projects. We are a dynamic research group within the Faculty of Pharmaceutical Sciences, working on various projects in regulatory science, market access, and clinical decision-making.
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.
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