Clinical Research Director

il y a 8 heures

Paris, Île-de-France Excelya Temps plein

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Clinical Research Director, you will have the opportunity to lead and manage clinical development programs, driving innovation in clinical research while building and mentoring a high-performing team.

This role is integral to the success of our clinical trials as you will ensure compliance with regulatory requirements, study protocols, and Good Clinical Practices (GCP) while striving to deliver impactful treatments to patients globally.

Main Responsibilities:

  • Provide medical leadership for clinical development programs in immunology, ensuring scientific and regulatory excellence
  • Lead and contribute to clinical document development, including protocols, informed consent forms (ICFs), amendments, and key regulatory documents
  • Deliver medical expertise to support real-world data pressure testing, operational feasibility, and study planning
  • Act as a medical point of contact for Health Authorities, Ethics Committees, investigators, CROs, and internal study teams
  • Prepare and actively participate in investigator meetings, monitoring meetings, and cross-functional study forums
  • Lead and support the set-up, governance, and operation of clinical committees (Steering Committee, Data Monitoring Committee, Adjudication Committee), including charters, meetings, and documentation
  • Provide medical guidance, training, and oversight to internal teams, CROs, and investigators throughout the study lifecycle
  • Contribute medical input to study plans, CRF design, deviation management, and risk mitigation strategies
  • Support data review and medical validation, including clinical case review, patient profile assessment, and narrative validation
  • Review and endorse Statistical Analysis Plans and contribute to key result interpretation
  • Support Clinical Study Report (CSR) development through drafting and review of key sections
  • Prepare for and respond to audits and inspections, and review draft scientific publications

About You:

  • Experience: Minimum of 10 years of experience in clinical research.
  • Skills: Strong knowledge of clinical trial methodologies, GCP, and regulatory requirements. Proven ability to manage complex projects, and communicate effectively with diverse stakeholders.
  • Education: Advanced degree (PhD) in Life Sciences, Medicine, or a related field. Certification in Clinical Research or Project Management is a plus.
  • Languages: Fluent in English and French, with excellent verbal and written communication skills.

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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