Last Date: July 27, 2023.
The Center for Biomedical Ethics and Law and the Center for Clinical Pharmacology and Pharmacotherapy are seeking a doctoral student to conduct research on the ethical and societal challenges related to the implementation of gene therapy in an internationally funded research project called GEREMY (https://heart-institute.nl/eu-horizon-grant-for-nlhi-coordinated-consortium-geremy/). The Center for Biomedical Ethics and Law at KU Leuven (www.cbmer.be) is an interdisciplinary research center that analyzes ethical and societal questions regarding innovations in biomedical research and healthcare. The Clinical Pharmacology and Pharmacotherapy research group (https://gbiomed.kuleuven.be/english/research/50000715/52577001/researchlines/research-lines) is a vibrant unit at the Faculty of Pharmaceutical Sciences that investigates challenges in regulation, market access, patient participation, and clinical decision-making related to drugs. Both units consists of a motivated team of researchers, including professors, postdoctoral researchers, and PhD students. The research groups collaborate closely with researchers from KU Leuven and UZ Leuven, as well as various external partners such as healthcare providers, patient organizations, government representatives, regulatory agencies, reimbursement agencies, and the pharmaceutical industry at national, European, and international levels. Staff members publish research in international academic journals, participate in national and international research projects, disseminate their findings through participation in national and international conferences, and are involved in providing advice to academic and professional organizations.
Project
Project Arrhythmogenic cardiomyopathy (ACM) is a condition affecting the myocardium, the heart’s muscle wall. A defect in proteins that connect heart muscle cells (myocytes) leads to the death of these cells, which are then replaced by scar tissue and fat cells. As a result, the heart muscle weakens and struggles to pump sufficient oxygen-rich blood to the rest of the body. Over time, ACM can lead to arrhythmias, heart failure, and sudden cardiac death. Current treatment options are only moderately effective in modifying or reducing disease progression, and there is currently no cure for inherited ACM. The GEREMY consortium (an international collaborative group funded by an EU Horizon grant) will investigate a new approach utilizing the potential of gene therapy (GT) to deliver the first cardiac gene therapy for the treatment of rare inherited forms of ACM. “Social embedding” of this new therapy is important to ensure that project goals, intermediate steps, and methods align with the needs and concerns of stakeholders who will be affected by the project’s outcomes (including physicians, patients, patient representatives, or public health policy makers) and to ensure that the ultimate project results from the GEREMY project are usable and implementable in decision-making by these stakeholders. Specifically, feedback from various stakeholders will be sought to ensure that the research priorities of the GEREMY project, including the clinical development program of cardiac gene therapy, research procedures, and selected endpoints, reflect what is most important to patients and society.
The PhD research project, which will be part of the GEREMY project, will adopt the framework of Responsible Research and Innovation (RRI). The aim of RRI is to align science, innovation processes, and outcomes with important societal values, needs, and expectations. This requires embedding ethics and social perspectives throughout the project’s lifecycle, with appropriate engagement of relevant stakeholders and a collaboration that is open, inclusive, and responsive to emerging issues. First, we will analyze existing normative policies and guidelines regarding the implementation of GT. Second, in collaboration with patient organizations EUPATI and the PLN Foundation, special attention will be given to mapping the opinions and perspectives of various stakeholders, such as physicians, patients, and patient representatives or public health policy makers, to ensure responsible implementation of the technology. We will also follow, collect, and analyze ethical guidance and literature on ethical and social issues, legal standards, and policy developments related to ATMP/gene therapy. This includes analyzing policy documents, regulatory documents, and relevant ethically related literature to provide an integrated regulatory and ethical framework for the implementation of patient-informed clinical trials with GT.
Profile
• You will conduct research (literature review, qualitative and quantitative surveys) in the described research domain. You will be involved in the design, setup, and execution of the research, and you will report on the results in scientific publications. This research aims to lead to a doctoral degree (PhD).
• You will work with other PhD candidates and colleagues within the research team.
• You will collaborate with external stakeholders (such as healthcare providers, patient organizations) to achieve widely supported solutions and recommendations.
• You will follow the program “Patient-related and Public Health Research” of the Doctoral School of Biomedical Sciences.
• You will supervise master’s students in carrying out their master’s theses.
• You will contribute to collective activities of the research group (such as educational services, lab meetings, research proposals, etc.).
• A master’s degree in Law, Pharmaceutical Care, Drug Development, Biomedical Sciences, Medicine, Bioethics, Social Sciences, or another relevant degree (Master’s level) with a pronounced interest in innovative technologies, patient-centered research, societal, and stakeholder perspectives.
• You are enthusiastic and committed to a four-year research project. You are ambitious, dynamic, flexible, and open to challenges and developments.
• You have good organizational skills and can work independently and make decisions.
• You have excellent social and written communication skills in English and Dutch (an extra asset).
• You can work in an international multidisciplinary team.
• You have good teaching skills and can coach and motivate others.
• You have experience with social scientific methods, such as qualitative methods.
Offer
A full time position within an internationally leading multidisciplinary team 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. Pascal Borry, tel.: +32 16 37 95 17, mail: [email protected] or Mrs. Eva Van Steijvoort, tel.: +32 16 32 11 40, mail: [email protected].
You can apply for this job no later than July 27, 2023 via the online application tool
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 [email protected].
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