AstriVax is a privately held spin-off company from the KU Leuven, founded mid 2022 with a seed round of €30 million to bring our ambition to the next level. We are building a first in class Plug & Play vaccine platform with a patented DNA based technology that launches self-amplifying live attenuated viruses on which additional targets can be added. The versatile technology of AstriVax can be used to develop a wide range of vaccines to prevent and treat infectious diseases, up to potential applications in oncology. We aim to address major challenges in vaccinology by developing novel vaccines that are single dose (game changing in vaccine landscape), easy to produce and with reduced cold chain requirements. The live attenuated viruses being launched from our products induce a polyfunctional immune response which has the potential to address many unmet medical need targets.
We are currently hiring a Clinical Development Lead.
YOUR MAIN RESPONSIBILITIES
- Participate in clinical development activities for a study or a number of studies including:
- Designing clinical trial protocols.
- Identify and map KOLs, investigators, and research centers within relevant therapeutic area in close collaboration with the clinical operations lead.
- Drive scientific discussions during site selection and initiation visits for successful clinical trials, support investigator meetings.
- Participate in vendor selection for clinical trials.
- Serve as medical monitor during the conduct of the clinical study, evaluate adverse events/serious adverse events (SAEs).
- Responsible for the review of the medical data listings for individual studies and assure medical consistency within trial and across trials within a program.
- Analyze and interpret the results as a subject matter expert.
- Development of clinical study reports.
- Assume accountability for the medical aspects and human safety aspects of the clinical study.
- Assure that results meet the highest standards of quality and ethical conduct. Liaise with Quality Assurance (QA), Clinical Operations, and Contract Research Organizations (CROs) to achieve these standards.
- Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
- Support to Independent Data Monitoring Committee (IDMC).
- Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant medical technical expertise and clinical development experience.
- Support regulatory team for successful submission of protocol to regulatory authorities.
- Stay informed about the latest developments in a specific disease area by reading scientific literature, attending important meetings, and building connections with Key Opinion Leaders (KOLs).
- Contribute to publications of clinical data in peer review journals.
- MD with at least 3 years of experience in clinical research.
- Strategic thinking skills and achievement oriented.
- Able to critically analyse information, identify strengths and weaknesses of approaches.
- Knowledge of clinical research, and biomedical research regulation, including ICH and GCP. Knowledge and understanding of vaccines is a plus.
- Excellent communicator.
- A real Team player with a CAN DO and solution-oriented attitude.
- Excellent knowledge of spoken and written English.
WHAT DO WE OFFER
A stimulating, open and collaborative environment where every employee can make an impact. We believe that we can only achieve our goal if we work together. You’ll be part of a passionate and inspiring team that goes the extra mile to address major challenges in vaccinology. We foster a culture of learning, entrepreneurship and innovation. Together we build the company.
Are you in for this new professional challenge? Pease send your CV to email@example.com, we welcome your talent!