Excelya

Clinical Research Director

Excelya

full-time

Posted on:

Location Type: Hybrid

Location: Paris • France

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Job Level

Lead

Tech Stack

Google Cloud Platform

About the role

  • 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

Requirements

  • 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.
Benefits
  • At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
  • 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.
  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial methodologiesGCPregulatory requirementsclinical document developmentdata reviewmedical validationStatistical Analysis PlansClinical Study Report developmentrisk mitigation strategiesCRF design
Soft Skills
project managementeffective communicationleadershipcollaborationtrainingoversightstakeholder managementproblem-solvingorganizational skillsadaptability
Certifications
Clinical Research certificationProject Management certification