# Clinical Research Director - Immunology

**Company:** [Excelya](http://jobs.workable.com/companies/hFGDKUsRdTmwSHu3NyNoMw.md)
**Location:** Paris, France
**Workplace:** hybrid
**Department:** Clinical Ops

[Apply for this job](http://jobs.workable.com/view/ac4bed35-a822-4c01-bcdd-3a44407d65ff)

## Description

**About the Job**

Excelya is seeking a **Clinical Research Director (CRD) in Immunology**, a **physician‑scientist** 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 cross‑functional 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 real‑world 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 cross‑functional 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.

## Requirements

**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.

## 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.