Clinical Development Specialist

Ref. GF0973

Location Loos (Lille) - France

Type of position Permanent position

Missions

Your responsibilities include, but are not limited to:

• Clinical Development: Work alongside the Clinical Strategy team to develop and implement clinical development strategies for assets in rare liver diseases ;
• Protocol Development: Support the design and writing of clinical trial protocols, ensuring alignment with regulatory requirements, scientific rigor, and ethical standards. Collaborate with cross-functional teams to optimize trial design and endpoints ;
• Clinical Trial Management: Oversee the planning, ensure execution, and monitoring of clinical trials, including patient recruitment, site selection, data collection, and safety monitoring. Proactively identify and address potential issues to ensure timely trial completion ;
• Data Analysis and Interpretation: Analyze clinical trial data and provide insights into safety, efficacy, and pharmacodynamic parameters. Generate high-quality clinical study reports and contribute to regulatory submissions ;
• External Engagement: Build and maintain relationships with experts, investigators, and study sites to support clinical trial activities and enhance scientific exchange ;
• Regulatory Affairs Support: Collaborate with the team to prepare regulatory submissions, responses to regulatory queries, and other documents required for product registration and approval ;
• Publication and Presentation: Prepare scientific manuscripts, abstracts, and presentations for publication in peer-reviewed journals and presentations at scientific conferences. Disseminate clinical trial findings to internal and external stakeholders.

In Addition, You Will

• Apply scientific expertise in the design of clinical studies in accordance with the clinical development strategy ;
• Contribute to the development of key study documents, including but not limited to study protocols, clinical sections of the investigator brochure and patient informed consents ;
• Ensure that insights obtained from external stakeholders (key opinion leaders, healthcare providers, investigators, investigational site study staff, patients/patient groups, etc.) guide clinical trial design and protocol development ;
• Support real world evidence and historical data initiatives to help drive decision making ;
• Perform clinical data reviews in collaboration with other functions, ensuring appropriate input from Data Safety Monitoring Board and/or Clinical Event Committee, where appropriate ;
• Contribute to clinical sections of regulatory documents (e.g., PIP, NDA, MAA, IND, IB, briefing packages) and support written and oral regulatory interactions from a clinical perspective ;
• Collaborate closely with the Clinical Team and other members of the study team to review key study metrics (e.g., enrollment data, patient retention rates, screen fail rates, protocol deviations) and determine appropriate actions ;
• Assist with the identification and selection of investigational sites and support sites during the conduct of studies in close collaboration with other members of the study team.

Profile

• Advanced degree in life sciences (MD, PhD, PharmD, MSc or equivalent) ;
• Demonstrated 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 ;
• Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities ;
• Strong analytical skills and strategic thinking applied to clinical strategy and trial design ;
• Demonstrated leadership and problem-solving skills ;
• Previous experience participating in or leading cross-functional development teams.
• Profound knowledge of ICH-GCP ;
• Ability to thrive in a fast-paced international environment, with the autonomy, flexibility and adaptability required to work in a biotech company ;
• Fluency in English and French (minimum B2 level) with excellent written and verbal communication skills.