Project Leader Clinical Development

Byondis is an independent Dutch biopharmaceutical company, based in Nijmegen, that focuses on developing innovative medicines against cancer and autoimmune diseases. We are driven by one goal: to develop new treatments to improve the standard of care for patients.

Your role

As clinical project leader, you are involved in defining the clinical development strategy within our proof of concept teams and you are responsible for detailed clinical trial design, protocol preparations and trail execution.

• You are the primary contact with clinical key opinion leaders and investigators.
• You will prepare documentation and presentations for scientific advice meetings with regulatory authorities.
• Byondis outsources most of the operational aspects of its clinical trials and as such you will manage and drive the selection of the Clinical Contract Research Organization and involved external laboratories and service providers.
• You will outline and prepare logistical plans and work closely with the clinical trial specialist and internal team as well as external parties to ensure adequate and effective management and oversight during the clinical trial execution.

We expect you to be able to quickly work independently on more than one project simultaneously. You work within a team of approximately 10 development professionals and will report to the vice president Clinical Development.

Your profile and skills

When considering candidates, we are looking for clinical trial professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

• Ph.D./M.D. in (bio)medical, pharmaceutical/health sciences or a related discipline, or at least five years of experience in a similar role.
• Experience in (early-phase) oncology, hemato-oncology or immune-oncology, either as clinician or biomedical research professional.
• Experience as a clinical trial manager/project leader in the pharmaceutical industry. In this role you have been responsible for the scientific content and operational execution of your projects.
• Experience with the preparation of scientific publications, scientific advice documents, CTA/CTIS documents and registration dossiers
• Experience in analyzing and evaluating medical scientific literature and are able to quickly grasp new indications to be explored.
• Knowledge of drug development (ICH GCP) regulations, processes and dynamics underlying international, multi- center clinical trials.
• Enjoy working in a team and are able to take initiative and persevere to get tasks accomplished.
• Pragmatic approach and able to maintain overview when working with deadlines and on different tasks simultaneously.
• Excellent verbal and written communication skills in English.

Benefits and well being

Besides a competitive salary, we offer you a dynamic working environment at our state-of-the-art campus in Nijmegen.  Our values as integrity, authenticity, entrepreneurship, quality and trust are very highly regarded. We also offer a good pension scheme, 30 days annual holidays based on a full-time position and we organize several company events throughout the year.

Join Byondis and create the future you want, today

• Contract hours: 32-40 hrs./week
• Salary: depending on experience
• Location: Nijmegen, with the ability to work up to 40% of the working hours remote
• Applicants must be nationals of a Member State of the European Union or hold a valid work permit for the European Union.

For further information, please contact Human Resources, at tel. +31 (0)24 679 5100 or by email; recruitment@byondis.com. If you are interested in joining Byondis in this challenging position, we welcome your application via the apply button. Please send your application before April 22 ^nd , 2025.

Acquisition by any commercial agencies will not be appreciated.