PhD candidate ‘Clinical research methodology for drug regulatory science in rare diseases’

Job title:

PhD candidate ‘Clinical research methodology for drug regulatory science in rare diseases’

Company:

Radboud University Medical Centre (Radboudumc)

Job description

We offer an exciting PhD position for a scientist with a strong background in clinical research methodology, preferably in the context of drug development and with a keen interest in the impact of novel methodology on drug development and regulatory science and decision making for rare diseases. Will you help us with further research?The position is part of the prestigious Innovative Health Institute funded RealiseD project. RealiseD implements a collaborative and comprehensive methodological and operational approach to clinical trials in rare diseases enabling timely drug development and approval centred on patients’ needs with high level of evidence reachable in a limited environment. It is a public private research collaboration, uniquely bringing academic institutions and networks, regulatory agencies such as the European Medicines Agency, Health Technology Assessment (HTA) bodies and pharmaceutical companies together.The PhD project will focus on providing the methodological evidentiary backbone and framework to develop and experiment with novel regulatory and HTA interaction pathways that foster the innovation in clinical trials needed for rare diseases. Testing insights with real rare disease-specific use cases in experimental interaction settings will be key to success.This overall objective is to be achieved in a multinational team and includes a range of sub-projects covering: scientific evaluation of existing regulatory and HTA assessment approaches, scientific evaluation of existing industry methods and practices for key decisions in clinical drug development, and development of an evidence assessment framework for regulatory and HTA evaluation useful throughout the full value chain up to the patient. These form the basis for novel regulatory, HTA, academic and industry interaction for rare disease drug development.You will work in the international team, supported by the local Radboudumc team with substantial expertise in rare diseases, drug development and regulatory science.Key scientific projects foreseen are:

• Regulatory science studies evaluating detailed assessment considerations in rare diseases, examining a wealth of existing real case studies of approvals as well as rejected applications to address the precise considerations around (novel, complex) design and methodologies of clinical evidence in case of rare diseases.
• Develop and test an evidence assessment framework facilitating the characterisation of uncertainties using innovative methods across all decision makers for rare diseases.
• Provide quantitative methodological tools and criteria to support implementing a regulatory validation or qualification pathway for novel methodologies covering market access and HTA.

RequirementsYou hold an MSc in a biomedical field, with a strong background in quantitative and research design methodology and/or epidemiology and/or pharmacology. Alternatively, you may have a quantitative background (such as an Msc in statistics, or econometrics) with demonstrated interest in biomedical applications. You have the personal skills to work in multidisciplinary and international teams.Conditions of employmentFixed-term contract: 4 years.At Radboud university medical center, you build on your future. We are committed to providing the best care, education, and research. And we are true to our word, because we help you develop and seize opportunities and give you the room to grow. As an employer, we believe that employees should feel vital and happy at work in all stages of life. We are also committed to creating a healthy and safe working environment. Our employment conditions contribute to that. What we offer:

• The salary depends on education. Scale 10 will be offered to MSc medical graduates; you will start at scale 10, step 0 (€ 3.493 full-time). Those holding degrees in other disciplines will be offered scale 10A: upon commencement of employment, you will start at scale 10A, step 0 (€ 3.017 full-time). Over a maximum period of 4 years, you will progress to step 4. You will also receive an 8% holiday allowance, an 8.3% end-of-year bonus, and a 47% to 72% bonus for working unsocial hours.
• 176 vacation hours per year based on a 36-hour working week.

EmployerRadboudumcThe Research and Education group Biostatistics is part of the Science Department at Radboudumc. It has a strong track record in statistical methodology for clinical research, with a focus on innovative designs and analysis of clinical research for personalized medicine and rare disorders, prediction modeling and modeling for infectious diseases. It has extensive joint projects with medical and research departments within the Radboudumc and is engaged in multiple national and international research projects in its key research areas. The section has a longstanding collaboration with the Dutch Medicines Evaluation Board (MEB-CBG). It includes leadership roles at the European Medicines Agency, and acts at the forefront of drug development and regulatory science.Radboudumc
Welcome to Radboud university medical center (Radboudumc), where scientific breakthroughs are born through the curiosity and passion of our collaborating researchers in a vibrant environment. We believe trust and excitement are crucial elements to achieving our goals, and we approach our research as teams and with the utmost rigor to make a significant impact on health and healthcare. Our researchers are driven by their fascination with the biological, psychological, and sociological mechanisms underlying health and healthcare. They collaborate with partners from all over the world to improve health outcomes for all. Radboudumc unites patient care, research, education, and corporate learning, which allows us to approach our mission to shape the health and healthcare of the future in an innovative and person-centered way.Our ambition is to lead the way in the pursuit of prevention, sustainability, meaningful care. We believe that through our research, we can significantly improve the health and well-being of society. Join us on our mission to make a difference in healthcare. Become a part of our community of gifted researchers, professionals or patient partners who are dedicated to making a real impact on population health and healthcare.Read what it is likeAdditional informationAny questions? Or wondering what it is like to work at Radboudumc? Then email to , Professor of Biostatistics and Head of the Biostatistics Research and Education group. Use the Apply button to submit your application.

Expected salary

Location

Nijmegen, Gelderland

Job date

Tue, 14 Jan 2025 23:50:16 GMT

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