Vacancy PhD candidate 'Clinical research methodology for drug regulatory science in rare diseases'

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.

Place of work

The Research and Education group Biostatistics is part of the Science Department IQ Health 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 like to do a PhD at the Radboud University Medical Center.

Profile

You 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.

Employment conditions

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.

And there is more..

• An Employment Conditions Selection Model, allowing you to use part of your employment conditions to your choosing. For example, you can use your gross salary to purchase additional vacation hours or hours for providing informal caregiving. Or, for example, you can use your gross end-of-year bonus to purchase a bicycle, so you pay less tax.
• Plenty of opportunities for personal development. You can take a variety of courses in our online learning environment. 
• Your well-being and vitality are a priority. For example:
  • Save time for work-life balance leave. 
  • You can enjoy unlimited access to a variety of activities five days a month and take advantage of all the facilities at Radboud Sport & Culture for only €27.05 per month (instead of €41)
  • Healthy Professionals program to help you manage your energy. 
  • Company Support Team and a personal coach if you are going through a life-changing event.
  • Financially beneficial working less through a Generation Scheme as you approach state pension age.
• Support in achieving a good work-life balance at every stage of your life. Examples:
  • Advice and courses on, for example, 'Millennial dilemmas' and 'Your Career After 57'.
  • Activities at our own mindfulness center.
  • Informal caregiving consultations if you have questions about juggling work and caregiving responsibilities at home.
• In addition to statutory pregnancy and maternity leave, Radboud university medical center offers 26 weeks of parental leave, nine of which are paid. In addition, as a partner you can take a maximum of five weeks of supplementary partner leave. During supplementary partner leave and parental leave, we supplement the UWV benefit up to 100% of your salary.
• Pension accrual at the ABP Pension Fund. Radboud university medical center pays 70% of the pension premium. 
• Discounts on supplementary packages of two group health insurances and ten other types of insurance, from home insurance to legal assistance.
• An allowance for your commuting costs of € 0.18 per km up to a maximum of 40 km one way. If you use public transport to commute, we will fully reimburse the public transport costs (2nd class). If you regularly work from home, you will receive a working from home allowance of € 2.40 per day.

Application procedure

Are you ready to think further for our patients and our care? We would like to receive your application before 10 February 2025. We will then contact you shortly. The job interviews take place in the weeks of 17 and 24 February 2025. Candidates should send their applications including a motivation letter (max. 1 page), a CV, and preferably the names and contact details of two persons who can provide references.

Good to know

• This position requires a Certificate of Conduct (VOG).
• You can find more information about our application procedure and frequently asked questions on our website.
• Will you be our new colleague? Then you will be given the time and space to get to know your role, your workplace, and your colleagues. An induction day for all new colleagues is an integral part of your onboarding program. 

We are recruiting for this position ourselves. Unsolicited marketing is not appreciated, but do feel free to share the vacancy in your network!

Contact

Any questions? Or wondering what it is like to work at Radboudumc? Then email to Prof. Dr. Kit Roes, Professor of Biostatistics and Head of the Biostatistics Research and Education group. Use the Apply button to submit your application.