JOB OFFER : Clinical Project Manager
KiOmed Pharma is looking for a Clinical Project Manager to work in close collaboration with the Head of Medical Affairs.
What KiOmed Pharma do
Capitalizing on a history of innovation and expertise in exclusive natural chitosan chemistry, KiOmed Pharma, a spinout from KitoZyme, develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as invalidating osteoarthritis, aesthetic medicine and ophthalmology.
Located in Belgium, Liège and composed of a fast-growing team, KiOmed Pharma has recently launched on the market its first class III CE marked medical device, KioMedineVSOne® indicated in the treatment of symptomatic patients suffering from knee osteoarthritis. A R&D pre-market pipeline of medical devices is currently under development, more specifically in dermo-aesthetic and ophthalmic diseases.
KiOmed Pharma has the ambition and the resources to grow to a worldwide class and aim at succeeding the commercial launches and growth on its markets.
- Manage the roll out of the Post Marketing Clinical Follow-Up plan (PMCF) for the osteoarthritis therapeutic area.
- Manage the update and follow up of the PMCF plan; as well as the PMCF and Clinical Evaluation Report (CER) for the osteoarthritis therapeutic area.
- Provide relevant clinical updates from the PMCF plan, in order to contribute to the support of regulatory submissions with the appropriate clinical evidence for the osteoarthritis therapeutic area.
- Responsible of the clinical studies in the osteoarthritis therapeutic area ( from planification to coordination), in close collaboration with the clinical research organisations (CROs).
- Maintain and share continuously up to date scientific knowledge in the field of osteoarthritis in order to discuss internally new devlopment opportunities.
- Develop close collaborationship with the scientific comminuties, especially Key Opinon Leaders (KOLs).
- Develop a comprehensive publication plan for the osteoarthritis therapeutic area.
- Close cross-functionnal collaboration with the different departments: R&D, Regulatory Affairs, Quality and Production.
- Report to the Head of Medical Affairs.
- University level , with a preference in human sciences (biomedical sciences, pharmacy,…).
- Experience of minimum 3 years in medical device class III and/or drugs.
- Experience in clinical operations ( ideally in osteoarthritis).
- Good knowledge of the regulatory framework regarding clinical studies (Good clinical practice (GCP), Ethics Committee, investigator, sponsor, protocol, investigator’s brochure, trial design, safety reporting, informed consent, statistics, clinical study/trial report).
- Strong project management skills.
- Presentation skills and data-analysis mindset.
- Rigorous , pro-active with a good sens of communication.
- Able to set up priorities and organize workload accordingly.
- Strong medical writing skills.
- Good statistical knowledge.
- Analytical and problem-solving skills.
- Capacity to operate in a fast moving organisation with an entrepreneurial culture.
- Exellent level of English and French (Italian, Spanish and/or German is a plus).
- Computer skills (Microsoft Office suite) and knowledge of project management tools.
- An opportunity to participate to the growth of a young and dynamic company in an innovative and fast-moving field, and particularly to the start of its commercial activity in the context of a new European regulation on medical devices.
- A possibility of hiring with a permanent contract.
If you are interested by this proposition, please send your CV and motivation letter in English to the following address: email@example.com