Convert Pharmaceuticals, a biotechnology company headquartered in Liège, Belgium, is looking for a Clinical Project Manager. Convert Pharmaceuticals is focused on developing a portfolio of novel cancer therapeutics, with the lead compound being a next-generation hypoxia activated prodrug (HAP)that shows more efficient targeting of treatment-refractory hypoxic areas, lowered systemic toxicity, and better synergy with current standard of care therapies. The company has successfully raised funds to progress its lead program all the way through to early clinical development.
We offer a full-time position of Clinical Project Manager (CPM). We are currently qualifying the lead compound of the technology for early stage clinical development and the candidate would prepare this transition and lead the project/studies as they emerge. A key responsibility will be preparing for and overseeing activities of the Phase I study in oncology patients. As part of a small and dynamic team, the CPM will lead the CRO and site selection process and manage all budget aspects, provide input for and review the phase I/Ib protocol, coordinate and supervise all vendors involved with the Phase I trial ensuring GCP adherence.
The CPM will be motivated by early stage clinical development, with a strong emphasis on biomarkers and translational research. Close interactions with preclinical, CMC and clinical functions, as well as the interactions with the Investigators and site staff will be key drivers of engagement. Ability to work independently while maintaining open and thorough communication is required. Regular presence at the Liege office will be needed and partial home-based work is an option. The CPM will report to the VP Clinical Development & Regulatory Affairs.
- Overall project management for the Phase I/Ib study, including timelines
- Input to and review of clinical study protocols
- CRO selection and supervision: clinical, central labs, data management, statistics, medical writing
- Site selection, study start up, co-monitoring and close out • Regulatory and Ethics Committee submissions
- Supervision of clinical study conduct • Database close, analysis and study report coordination
- Budget and contracts management Profile • MD or PhD or Master with biomedical, biochemical or biotechnological background and strong interest in oncology
- Experience with early clinical development, particularly Phase I (oncology experience is a plus but not a requirement)
- Proficient in managing and coordinating vendors
- At least 7 years clinical operations experience of which 3 as clinical project manager
- Structured and highly organized with a pro-active attitude
- Good understanding and experience with implementation of GCP
- Excellent communication skills (oral as well as written)
- Self-motivated and a true team player
- Proficient in MS office (excel, word, power point)
- Fluent in English (oral and written) is a must, French or Dutch is a plus
Contact information : [email protected]