Les missions du poste
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.
Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.
We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.
Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
About the Job
Excelya is seeking a Clinical Research Director (CRD) in Immunology, a physicianscientist responsible for providing medical leadership and scientific oversight across clinical development programs in immunology.
The Clinical Research Director acts as the medical reference for assigned clinical trials, ensuring scientific quality, patient safety, regulatory compliance, and crossfunctional alignment throughout the clinical development lifecycle.
Main Responsibilities:
- Lead the medical and scientific oversight of clinical trials in immunology across development phases.
- Author, review, and approve key clinical documents including abbreviated protocols, clinical protocols, informed consent forms (ICF), and related protocol/ICF amendments.
- Provide medical support for study feasibility assessments and realworld data evaluations relevant to clinical development.
- Contribute to responses to Health Authorities (HAs), Ethics Committees (ECs), clinical sites, and global/local study teams.
- Participate in, prepare for, and contribute to investigator meetings, monitoring meetings, and crossfunctional project meetings.
- Establish, manage, and provide ongoing oversight of expert committees, including Steering Committees, Data Monitoring Committees (DMCs), and Adjudication Committees, covering member selection, charter development, meeting coordination, reporting, and documentation.
- Provide medical guidance, training, and support to internal teams (Clinical Study Operations, Global Study Managers, biostatistics, Medical Affairs, Clinical Project Leaders), CROs, and investigators.
- Provide medical input into study plans, including Clinical Monitoring Plans (CMP), Medical Review Plans (MRP), Data Review & Data Surveillance strategies (DR & DS), Safety Risk Management Plans (SRMP), CRFs, CRF completion guidelines, and deviation management.
- Support data review activities, statistical surveillance, medical coding, medical validation, and development of clinical case review materials.
- Perform clinical case reviews including patient profile assessments and review/validation of narratives.
- Review and endorse Statistical Analysis Plans (SAPs).
- Contribute to the preparation of key study deliverables, including Clinical Study Reports (CSR) and review of scientific publications.
- Prepare for and respond to audits and regulatory inspections related to clinical development activities.
Le profil recherché
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'sleading mid-size CROwith thebest employee experience. Ourone-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 caremeans 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.
About You:
- Experience: Medical Doctor (MD) with proven expertise in immunology and clinical research.
- Strong experience in clinical development and medical leadership roles.
- Education: Medical Doctor (MD) or Clinical Physician degree required; additional certifications in clinical research or project management are a plus.
- Skills: In-depth knowledge of immunology clinical trials, regulatory environments, and GCP standards; excellent leadership, communication, and organizational abilities.
- Languages: Fluent in English and French is preferred.