Chief Medical Officer
Our customer is a biotechnology company in the Liège area in Belgium focusing on researching and developing novel therapeutic candidates based on Exosomes, known as extracellular vesicles. It has been known that its biological functions include intracellular communications between the cells, transfer of proteins, lipids, genetic material, and signaling to the recipient cell via cell-surface or endosomal receptors. Currently, EVs have been studied as drug delivery systems for therapeutic delivery because they can cross the blood-brain barrier. Exosomes are gaining momentum in the scientific community as potential alternatives to stem cell therapies. In recent years, there has been an increasing number of publications related to the unlimited applications areas which can be used for prognosis, for therapy, and as biomarkers for health and disease. The company has strong partnerships and influential networks for collaborating and researching new medical treatments, including research centers, public universities, and private partners. The primary mission is to provide affordable and accessible therapies to patients with unmet medical needs.
Chief Medical Officer (CMO) is responsible for preparation of the clinical study and overseeing the day to day operations of clinical trials.
Company is planning to perform multiple international clinical projects starting from 2021.
Job requires from the candidate a medical background and good experience in management of clinical projects.
Due to the job nature some activities can be performed remotely from home. It will also require flexibility for travel to the international test centers.
- Managing and coordinating the national and international clinical trials starting from the study set-up until the closure of the clinical tests.
- Being responsible for the performance of the principal investigators and the physicians.
- Ensuring that patients receive the highest standard of safety and medical care.
- Ensuring that all the regulations and safety standards are met i.e. GCP.
- Updates on new healthcare regulations.
- Liaising between the sponsor, CRO and the medical staff.
- Collaborate with the CRO with recruitment and mentoring physicians.
- Managing the CRO’s and hospital budget.
The responsibilities of the CMO include, but are not limited to, the following functions:
- Implementation and management of the GCP principles according to international and national law and regulations.
- Acknowledgement and maintenance of the QMS system, including but not limited to the GCP guidelines.
- Ensuring to be up to date as concerning the applicable directives, guidelines, standards and applicable laws is concerned.
- Ensuring that she/he participates in regular and continuing education and professional development programs and in particular when procedures change, or scientific knowledge develops.
- To ensure that all necessary pre-clinical and clinical testing is carried out and the associated records evaluated.
- Monitor development and validation of the clinical testing.
- Ensuring that the establishment puts in place and updates a Quality Management System.
- Determine and provide the resources required to implement, maintain and improve an adequate and effective Quality Management System.
- Organize internal audits and external audits and inspections.
- To approve and monitor any contract organizations and hospitals responsible for clinical tests.
- To ensure the qualification and maintenance of her/his department, premises and equipment.
- To ensure that the required initial and continuing training of her/his department personnel is carried out and adapted according to need.
- Maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule.
- Verify that the study plan contains the information required for compliance with these principles of good clinical practice. This verification should be documented.
- Conduct inspections to determine if all clinical studies are conducted in accordance with these principles of good clinical practice. Inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed. Inspections of the Test sites might require travel.
- Inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies.
- Promptly report any inspection results in writing to the CSO and/or the Board of Directors.
- Prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
- Medical degree.
- 8+ years clinical experience.
- 4+ years experience as manager of clinical projects.
- Good organizational and communication skills.
- Excellent written and verbal communication skills in English.
- Languages: English.
- Master of Health Administration (MHA) is advantageous.
- You will report directly to the CSO.
- The company offers you a complete and competitive salary package.
- Part of a promising start up company.
- Every day brings new challenges and new things to learn.
Do you feel motivated to apply for the job?
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We will gladly take the necessary time to evaluate your application thoroughly.
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+32 471 793 953