Job Properties
  • Job Type
    Full-time Position
  • Category
    Supply Chain & Logistics
  • Languages
    English Dutch
  • Experience Required
    Entry
  • Degree Required
    Bachelor
    • Province
      Nijmegen
    • Date Posted
      August 25,2022
    • IMG_6430
    • VISA
    • Premium Package

    Project Leader Clinical Development

    Application deadline:
    15/09/2022
    Expected Start Date:
    ASAP
    Contacts:
    Penny de Villiers
    Mobile: +31 639103707
    Company homepage:
    www.byondis.com
    Office address:
    Microweg 22, 6545CM Nijmegen


    Byondis B.V. is an independent, Dutch biopharmaceutical company creating precision medicines targeting intractable cancers and autoimmune diseases. We are passionate about transforming patients’ lives. We are pioneering and bold in action.

    Our Clinical Development Department is expanding and we are looking for a project leader who has formidable clinical development experience, to grow our team. It's an exciting time to join because you will have the opportunity to execute global studies in early phase clinical development in the area of immuno-oncology and hemato-oncology with our novel ADC technologies and immune-oncology portfolio. 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.

    Your Role

    As clinical project leader, you are involved in defining the clinical development strategy and you are responsible for detailed clinical trial design and protocol preparations. 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 CRO and involved laboratories and service providers. You will outline and prepare logistical plans and closely work with the external clinical parties to ensure adequate and effective management and oversight during the clinical trial execution. You will contribute to the preparation of the clinical sections of the BLA/MAA dossiers. We anticipate that you will quickly beable to work independently on more than one project simultaneously. You work within a highly motivated team of approximately 10 development professionals and you will report directly to the Vice President Clinical Development.

    Your Profile
    • Ph.D./M.D. in (bio)medical, pharmaceutical/health sciences or a related discipline, or at least three 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 and registration dossiers;
    • Excellent command of the English language.

    In interviews you will be able to demonstrate that:
    You have experience in analyzing and evaluating medical scientific literature and you are able to quickly grasp new indications to be explored. You have a good understanding of the (GCP) regulations, processes and dynamics underlying international, multi-center clinical trials. You enjoy working in a team and you are able to take initiative and persevere to get tasks accomplished. You have a pragmatic approach and you are able to maintain an overview of your work when working under time pressure and on different tasks simultaneously

    What we Offer

    State-of-the-art R&D environment and GMP manufacturing facilities. The opportunity to join highly educated scientists and be part of breakthrough research and results which have the potential to transform patients’ lives.

    We develop new biological entities and new chemical entities using proprietary molecular concepts and technologies to generate next generation antibody-drug conjugates (ADCs). Our broad portfolio comprises preclinical as well as early- and late-stage clinical development programs, including the anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985).
    Located in Nijmegen, the oldest city in the Netherlands and a high-tech and science hub, Byondis has a dedicated team of about 400 staff. We regularly collaborate with leading, global biotechnology and pharmaceutical companies, as well as many academic research institutions.
    Byondis provides a dynamic workplace where all ideas are welcome and the values of trust, quality, entrepreneurship, integrity and authenticity are of paramount importance.

    We offer a competitive salary, a pension scheme, 30 days annual holidays based on a fulltime position and we organize several company events throughout the year. Relocation allowance is made available to non-Dutch citizens.

    Contract and location

    Contract hours: 32-40 hours/week.
    Salary: depending on experience.
    Location: Office-base in Nijmegen, with the ability to work remotely for part of the week.

    If you are interested in this challenging position, we look forward to your application .

    Important dates

    Please send your motivation before September 15, 2022

     
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