Our client is a late-stage clinical biotechnology company specializing in the development of therapeutics that treat autoimmune conditions and aim at repairing damaged tissues and organs.

Your responsibilities:

• Accountable for the clinical development strategy for the portfolio, design and create integrated clinical development plans for all projects

• Provide medical and clinical leadership for the programs, including direct responsibility for the development of study protocols and execution of clinical trials, ensuring adherence to good clinical practices, regulatory requirements and ensuring the safety and wellbeing of patients in our trials

• Responsible for oversight of studies performed by contract research organizations on behalf of the company, ensure medical review and assessment on patient data; review of study documents; assessing subject eligibility; safety analysis, benefit risk evaluation and mitigation strategies

• Provide guidance for the multi-disciplinary project and study teams for the successful execution of the projects; collaborate with regulatory advisors in developing regulatory strategy and shaping new regulatory pathways

• Collaborate with the top Management- under the direct control of the CEO- in developing overall company strategy, meeting business objectives, and attracting, leading, and developing our talents

• Responsible for shaping external medical and scientific communications, establishing strong collaborations with academic investigators and key opinion leaders, understanding the competitive landscape and involved in strategically meaningful collaborations

• Participate to the presentation of the company with CEO/CFO/ CIRO in investor relations/outreach business and financial interactions

Requirements:

• You own a MD, or MD/Ph.D. degree in relevant disease/therapeutic areas

• Field experience in clinical, or biopharmaceutical industry and leading clinical development of new treatments, particularly in oncology and immunology; pertinent knowledge in regulatory development pathways is required

• Demonstrated leadership skills with proven results, strong collaborative, and communications skills, strong ability to interact with the scientific /academic community

• Strong interpersonal skills, high emotional intelligence; hands-on when necessary, and results/outcomes oriented

• Demonstrated scientific accomplishments with track record of publications, and presentations (expertise in auto-immunity and cell therapy)

Offering:
• Position based in Mont Saint Guibert (Belgium) and Paris (France), with frequent travels at clinical sites in Europe and USA
• Competitive package based on experience