Clinical Development Specialist (F/H/X)

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries. Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.fr

The Clinical Development Specialist is a part of the Clinical Development team and is responsible for contributing to the design of clinical studies, to the review of clinical data and to authorship of scientific documents. The Clinical Scientist supports the clinical development strategy, in accordance with GENFIT corporate objectives.

MISSIONS:

Your responsibilities include, but are not limited to: 

1. Clinical Development: Work alongside the Clinical Strategy team to develop and implement clinical development strategies for assets in rare liver diseases and/or oncology ;

2. 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 ;

3. 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 ;

4. 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 ;

5. External Engagement: Build and maintain relationships with experts, investigators, and study sites to support clinical trial activities and enhance scientific exchange ;

6. Regulatory Affairs Support: Collaborate with the team to prepare regulatory submissions, responses to regulatory queries, and other documents required for product registration and approval ;

7. 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 and/or oncology 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.

With respect to recruitment, GENFIT commits to providing equal treatment to all applicants, regardless of gender, age, sexual orientation, ethnicity, race, citizenship, disability status, religion, or any other discriminatory characteristic under applicable laws. By choosing to apply for a position at GENFIT, you agree that fostering an inclusive and diverse work environment is our shared responsibility.