Clinical Research Director - #46490

Excelya


Date: il y a 1 semaine
Ville: Boulogne-Billancourt, Île-de-France
Type de contrat: Temps plein

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


    Requirements

    About You:

    • Experience: Proven experience 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

    Benefits

    Why Join Us?

    At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

    Here's what makes us unique.

    We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

    Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

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