Clinical Research Director – Immunology
Excelya · Paris
Description du poste
About the role
Excelya is looking for a Physician‑Scientist to lead medical and scientific oversight of immunology clinical development programs. The Clinical Research Director will act as the primary medical reference for assigned trials, ensuring scientific quality, patient safety, and regulatory compliance throughout the development lifecycle.
Key responsibilities
- Lead medical oversight of immunology clinical trials across all phases.
- Author, review, and approve protocols, informed consent forms, and related amendments.
- Provide medical input for feasibility assessments, real‑world data analyses, and regulatory submissions.
- Participate in investigator, monitoring, and cross‑functional project meetings.
- Establish and manage expert committees such as Steering and Data Monitoring Committees.
- Support internal teams, CROs, and investigators with medical guidance and training.
- Contribute to study plans, safety risk management, data review strategies, and case review materials.
- Review and endorse statistical analysis plans and clinical study reports.
- Prepare for and respond to audits and regulatory inspections.
Required profile
- Medical Doctor (MD) with proven expertise in immunology and clinical research.
- Strong experience in clinical development and medical leadership roles.
- Fluent in English; French is a plus.
Required skills
What we offer
- Opportunity to shape immunology drug development at a science‑focused company.
- Collaborative environment with cross‑functional teams.
- Competitive compensation and benefits package.
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Excelya
Paris
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