Our client is a fast-moving biopharmaceutical company specialized in vaccines. They are currently initiating a new project on an HIV vaccine candidate which is currently evaluated in a preclinical phase, to rapidly move into phase I of the development. Additionally, they are developing a portfolio of other vaccines in clinical and preclinical phase.
You are looking for a professional challenge that allows you to work in a start-up environment in order to lead Preclinical Projects ?
Coordination of different partners (external/internal) in a research phase is a great opportunity and as an expert in Vaccinology you want to apply your competences in this field?
Plus One can offer you this great challenge:
Your key responsibilities:
- Coordinate the preclinical toxicology study and CMC production for a vaccine candidate (HIV):
- Execute the plan as it has been defined with extrnal partners (CMOs and CROs)
- Monitor the progress of the manufacturing of the vaccine
- Monitor the toxicology study
- Monitor budget and planning and present to the Board of the project
- Ensure proper compliance of the project, in coordination with the Quality Director
- Write protocols, scientific reports and the IMPD (with mentorship of experienced writers)
- Be part of the discussions with the clinical team (external and academic partners) that will submit the Clinical Trial Application and who will lead the clinical study
- Report progress and results to company management
- Coordinate various preclinical experiments done with external suppliers
- Review the protocols and select the most appropriate suppliers
- Visit the sites, to ensure compliance with the company standards (in collaboration with Quality Director)
- Monitor progress and quality, as well as budget and planning
- Recommend solutions in case of divergence