Clinical Scientist
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Its capacity to develop high potential assets, from early-stages to late development and pre-commercialization stages, is illustrated through the successful 52-week readout of its Phase 3 trial (ELATIVE®) evaluating elafibranor in Primary Biliary Cholangitis (PBC). Today, GENFIT has a diversified R&D pipeline covering several therapeutic areas: five programs in acute on chronic liver failure (ACLF) are in clinical stages (Phase 2) and pre-clinical stages, including hepatic encephalopathy (HE), one of the main complications of ACLF; a Phase 2 clinical program targeting cholangiocarcinoma; and a preclinical program targeting urea cycle disorders (UCD) and organic acidemias (OA). GENFIT’s pipeline also includes a diagnostic franchise focused on Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis or NASH) and ammonia. GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. For more information, visit www.genfit.com
The Clinical Scientist 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 with a primary focus on North America and Europe.
The location is flexible and this position may be located in Lille (France), Zurich (Switzerland), or Cambridge, MA (United States).
MISSIONS:
Your responsibilities include, but are not limited to:
- Applying scientific expertise in the design of clinical studies in accordance with the clinical development strategy;
- Contributing to the development of key study documents, including but not limited to study protocols, clinical sections of the investigator brochure and patient informed consents;
- Ensuring 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;
- Supporting real world evidence and historical data initiatives to help drive decision making;
- Performing clinical data reviews, in collaboration with other functions, ensuring appropriate input from Data Safety Monitoring Board and/or Clinical Event Committee, where appropriate;
- Contributing to clinical sections of regulatory documents (e.g., PIP, NDA, MAA, IND, IB, briefing packages) and supports written and oral regulatory interactions from a clinical perspective;
- Collaborating with the Clinical Team Leader 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 to determine appropriate actions;
- Assisting with the identification and selection of investigational sites and supporting sites during the conduct of the study in close collaboration with other members of the study team;
- Assisting with the identification, selection and training of vendors to support clinical studies;
- Assisting with inspection readiness activities for assigned clinical trials;
- Contributing to the development, review and training for SOPs.
PROFILE:
- You have an advanced degree in life sciences (MD, PhD, PharmD, MSc or equivalent) and 3+ years of experience in clinical research, including clinical study design and engaging with scientific leaders and healthcare providers;
- You have strong analytical skills and strategic thinking as applied to clinical strategy and trial design;
- You have demonstrated leadership and problem-solving skills;
- You have experience in liver diseases;
- You have previous experience in participating in or leading cross-functional development teams;
- You have profound knowledge of ICH GCP;
- You thrive in a fast-paced, international environment and you have the autonomy, flexibility and adaptability to work in a biotech company;
- You are fluent in English (B2+ level minimum), with excellent written and verbal communication skills (some knowledge of French is a plus).
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.