Ongeveer 23 uur geleden - Universiteit Leiden (LEI) - Leiden
Project manager for Clinical Trial Pediatric Scientific Advice
Currently, approximately 40-60% of drugs prescribed to children are off-label. Their efficacy and safety have not been adequately studied. This leaves …
- Geert Grooteplein Zuid, Nijmegen, Gelderland
- Tijdelijk contract / Tijdelijke opdracht
- Uren per week:
- 36 - 36 uur
- € 2659 - € 4917 per maand
Currently, approximately 40-60% of drugs prescribed to children are off-label. Their efficacy and safety have not been adequately studied. This leaves children at an increased risk of therapy failure or drug toxicity. One of the main roadblocks to adequately studying drugs in children, is lacking infrastructure to perform both industry and investigator-initiated trials. This leads to delayed or even cancelled trials, thereby not contributing to more effective and safe therapy, and resulting in wasted resources. To address this lack of successful pediatric trials, the Innovative Medicines Initiative provides funding to build a European-wide pediatric trial network.
As part of these activities Radboudumc will host a EU-wide one-stop shop for pediatric scientific advice and innovation. Pediatric trials pose specific ethical, scientific and practical challenges. Innovative scientific advice for pediatric trials and/or complete pediatric drug development programs may overcome these challenges. This one-stop shop aims to provide this advice, combining expertise from groups of clinical experts, methodology experts and patients/parents representatives. In this effort the network will collaborate with relevant stakeholders including existing networks, funders and regulators.
We expect the project manager to coordinate and develop methods for efficient and innovative scientific advice for pediatric drug trials and development programs. An Europe-wide advice network, advice reports, organization of multi-stakeholder meetings and dissemination of best-practices for pediatric drug development programs are short-term success outcomes. Long-term metrics will be a sustainable innovative advice organization serving both industry, investigators and other relevant stakeholders as part of the larger European pediatric clinical trial network. This position presents an unique opportunity to be part of the largest European pediatric research infrastructure project to date (130 million euros, 6 years) and ultimately contribute to effective and safe drug therapy for children. Management assistance will be available to support the project director with the network activities.
You should be a pro-active and independent research project manager, research coordinator or similar, with an MSc (or proven experience at least at Master level) in Medicine, Biomedical Sciences, Pharmacy or Nursing, with a expertise in drug development. Excellent communication skills (Dutch and English) and experience with complex, international project management are essential.
Experience with pediatric trials, network building and working experience in both academia and industry is a pre. You should be able to communicate, verbally and in writing, on different international and intercultural levels. Your progress monitoring is excellent and you also have a good sense of organization awareness. You are expected to support the other project managers also working on EU pediatric research infrastructure projects at the Department of Pharmacology and Toxicology. Willingness and flexibility to regularly travel both nationally and in Europe is a prerequisite.
You recognize yourself in the Radboud way of working.
ConditionsProject funding is available for 6 years. Your performance will be evaluated after 1 year. The contract can be extended dependending on performance, including a permanent contract. Read more about the Radboudumc employment conditions and what our International Office can do for you when moving to the Netherlands.
Upon commencement of employment we require a certificate of conduct (Verklaring Omtrent het Gedrag, VOG) and there will be a screening based on the provided CV. Radboud university medical center's HR Department will apply for this certificate on your behalf.
Applicants should send a letter of intent (in pdf) outlining special interest in the position and a CV.
Additional information about the vacancy can be obtained from Prof. Saskia de Wildt, full professor of Clinical Pharmacology. Use the Apply button to submit your application.
This vacancy is open until filled.
Recruitment agencies are asked not to respond to this job posting.