Clinical Development Strategist - Rare Liver Diseases

Genfit SA; Lille; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

GENFIT is seeking a Clinical Development Specialist to contribute to the design of clinical studies, review data and author scientific documents within the Clinical Development team. The role supports development strategies for rare liver diseases and regulatory alignment.

Fluent in English and French (minimum B2), you will collaborate with cross-functional teams, manage key study documents, and contribute to regulatory submissions and publications to advance asset progression.

Qualifications

• Advanced degree in life sciences (MD/PhD/PharmD/MSc or equivalent).
• Experience in clinical research and drug development, preferably in the biopharmaceutical industry.
• Expertise in liver diseases would be a plus.
• Strong understanding of clinical trial design, execution, and regulatory requirements.
• Excellent analytical, communication, and teamwork skills.

Responsabilités

• Clinical Development: Work with the Clinical Strategy team to develop and implement development strategies for assets in rare liver diseases.
• Protocol Development: Support design and writing of clinical trial protocols, ensuring regulatory alignment and scientific rigor.
• Clinical Trial Management: Oversee planning, execution, recruitment, site selection, data collection and safety monitoring.
• Data Analysis and Interpretation: Analyze trial data and contribute to regulatory submissions and study reports.
• External Engagement: Build relationships with investigators and study sites to support clinical trial activities and scientific exchange.

Connaissances

Clinical research

Drug development

ICH-GCP

Regulatory affairs

Teamwork

Formation

MD, PhD, PharmD, MSc or equivalent

Description du poste

GENFIT is seeking a Clinical Development Specialist to contribute to the design of clinical studies, review data and author scientific documents within the Clinical Development team. The role supports development strategies for rare liver diseases and regulatory alignment.

Fluent in English and French (minimum B2), you will collaborate with cross-functional teams, manage key study documents, and contribute to regulatory submissions and publications to advance asset progression.