Clinical Research Director I&I at Excelya. About the Job. Join Excelya, where . Audacity, Care, and Energy. define who we are and how we work. As the Clinical Research Director for Inflammation and Immunology (I&I), you will lead critical clinical programs and play a pivotal role in advancing innovative therapies for patients.. This remote role empowers you to influence clinical strategy significantly, ensuring that we not only meet regulatory standards but also create optimal study designs that translate into successful patient outcomes.. Main Responsibilities:. Lead the clinical development of projects in the . Inflammation and Immunology therapeutic area. from inception through to the successful execution of clinical trials.. Ensure compliance with . regulatory requirements, ICH-GCP principles. , and internal procedures throughout the trial lifecycle.. Develop and approve key clinical documents including protocols, informed consent forms, and study amendments.. Work closely with cross-functional teams to define clinical strategy, operational processes, and delivery timelines.. Serve as the primary medical and scientific contact for Health Authorities, Ethics Committees, investigators, and key stakeholders.. Oversee and guide the design, governance, and conduct of clinical committees, ensuring adherence to governance standards.. Conduct medical assessments of data, engage in data review processes, and provide insights on protocol deviations and safety monitoring.. Participate in the development and review of clinical study reports and publications.. Lead the training and mentorship of clinical teams and CRO partners to ensure effective study execution.. Represent Excelya in external forums, conferences, and meetings to communicate scientific and strategic objectives.. About You:. Experience:. At least 10 years in the clinical research arena, with significant experience in leading clinical trials in Inflammation and Immunology.. Skills:. Solid understanding of clinical trial methodology, pharmacokinetics, and biomarkers. Strong leadership, communication, and project management skills.. Education:. Medical degree (MD) or Clinical physician in a relevant biomedical science field. Additional certifications in Clinical Research or Project Management are highly desirable.. Languages:. Fluent in English and French, with proficiency in scientific writing and communication.. Company Location: France.
Clinical Research Director I&I at Excelya