[Hiring] Senior Clinical Scientist Immunology @Excelya

Role Description

As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.

• Support and represent the Study Medical Manager throughout the clinical study lifecycle.
• Contribute to the development and review of key clinical documents, including protocols, protocol amendments, informed consent forms (ICFs), CRFs, and medical data validation plans.
• Perform medical review of patient data, listings, narratives, CIOMs, and clinical cases.
• Collaborate closely with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams to support data review and consistency checks.
• Review study-related documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs.
• Support the preparation and management of study committees, investigator meetings, and study training activities.
• Maintain medical and scientific documentation within the Trial Master File (TMF).
• Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and study teams.
• Develop medical review guidelines and support outsourced medical review activities when applicable.
• Contribute to audit and inspection readiness activities and support responses to findings.

Qualifications

• Advanced degree in Medicine (MD), Pharmacy (PharmD), Life Sciences, or related scientific discipline.
• Strong experience as a Clinical Scientist, Medical Scientist, Clinical Research Physician, or similar role.
• Experience supporting clinical studies in Immunology & Inflammation and/or Oncology.
• Strong understanding of clinical development, study design, and clinical trial conduct.
• Knowledge of ICH-GCP, regulatory requirements, and clinical research processes.
• Experience reviewing clinical data, patient profiles, narratives, and safety information.
• Familiarity with Clinical Study Reports (CSRs), protocols, and TMF documentation.
• Strong cross-functional collaboration and communication skills.
• Fluent English, written and spoken.

Benefits

• We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.
• Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects.
• By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.
• Excelling with kindness means evolving in an environment that values ​​your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.