Responsibilities:
As a Chief Medical Officer, you lead the company’s clinical developments.You develop and execute the clinical plans for the Phage Therapy products. You also provide medical insights for the products testing and marketing strategy. As part of the ExCom, your main responsibilities are as follows: You develop clinical plans and protocols in order to meet regulatory and disease strategy targets. You translate protocol strategy into objectives and relevant action plans.You manage a small team, stakeholders and governance bodies to You collaborate with Clinical Operations and designated CROs to execute the programs. You lead study start up and database lock, perform data reviews, draft/present clinical slides for Investigators Meeting, Advisory Boards, monitor training, review draft CRFs, etc. You provide clinical programs with clinical leadership and medical strategic input. You participate to medical marketing, clinical development, and communication activities. This includes the organization of demonstrations and assisting hospital teams in the correct application of the personalized phage therapy model. You ensure the molecule safety, and support program safety reporting with the QA department. You work with academic leaders/advisers to develop the clinical strategy. You regularly report work and projects evolutions to the top management. Profile: Medical Doctor degree with a minimum of 5 years in phase I-III trials in the biotech industry. You have a strong understanding of pharmaceutical drug product development, including clinical trial management, IND and NDA submissions, medical monitoring, and GCP principles.You are recognized as an expert/reference in phages and AMR, or would like to become one. You show experience with Clinical Operations, Pharmacology, Medical and Regulatory Affairs, etc. You are able to analyze, interpret and present scientific data and drug development programs. You demonstrate proven leadership and people management skills. You are able to work within a multi-disciplinary team of peers and external experts. You are fluent in English. You are flexible and able to travel abroad. Offer:A challenging position within the executive committee of a high-potential biotech company. The opportunity to lead the development of innovative solutions to fight antibiotic-resistant infections
Job ID: 114017
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