Clinical Research Director (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 has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor²) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com

The Clinical Research Director, reporting to the SVP, Clinical Strategy, has primary responsibility for working on and executing clinical development activities for assigned investigational asset(s) in development. The Company's pipeline programs span all phases of clinical development (preclinical to Phase 3): you manage the clinical development of assigned asset(s), including executing on the clinical development strategy, study design, monitoring during the conduct of clinical trials, data analysis, regulatory reporting, and publication.

MISSIONS:

Your responsibilities include, but are not limited to:

Lead the development of clinical study plans and corresponding clinical sections of the Global Development Plan in accordance with the global program strategy;
Lead the development of the abbreviated clinical trial synopsis, the protocol, protocol amendments, and the clinical study report including medical writing;
Contribute to the clinical sections of the Investigator’s brochure, CTA, IND, DSUR, RMP, other regulatory documents;
Contribute to the clinical sections of the BLA/CTD, briefing packages for regulatory meetings, PSP/PIP;
Contribute to scientific and authorship activities for the assigned clinical study(ies) as it pertains to authoring of manuscripts and abstracts; prepare and participate in advisory board meetings;
Contribute clinical content to development of the clinical trial statistical analysis plan in collaboration with biostatistics and other functions;
Support and oversee the execution of (a) clinical study(ies) and provide medical/scientific input to clinical trial operational activities;
Contribute to the establishment of clinical trial timelines, provide input to contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs), assisted by related functions (e.g., clinical operations, project management, and others);
Facilitate and implement study specific committees (iDMC, adjudication, etc.) with operational support and as guided by the SVP, Clinical Strategy;
Perform or support medical monitoring activities of the assigned study(ies);
Provide medical support to clinical operations team during feasibility stage when identifying clinical sites for new clinical trials ;
Provide clinical input across various study-specific documents including written subject information, CRF, e-diary, monitoring plan, patient diary, other for the assigned study;
Participate in continuous medical review of aggregated data during clinical trial conduct (safety, statistical outputs of blinded data, …), supported by clinical operations, biostatistics and safety functions;
Draft initial responses to study-specific medical/scientific questions raised by Regulatory Authorities, EC/IRBs, and sites for review and approval by SVP, Clinical Strategy;
Support trial master file documents readiness and availability, and mandatory trainings linked to the clinical function;
Support biometry with key study results preparation in advance of review by the SVP, Clinical Strategy and Chief Medical Officer (CMO) and prior to dissemination within Genfit;
Assist in collaborating with external partners, KOLs, and diverse internal stakeholders as guided by the SVP, Clinical Strategy;
Stay on top of the scientific development relevant to the assigned asset(s) by - including but not limited to - review of relevant scientific literature and competitive intelligence, on a regular basis, draft initial assessments for evaluation and approval by the SVP, Clinical Strategy and CMO prior to making company decisions, etc.;
Contribute to planning coverage and summarizing scientific and clinical new information from congresses and scientific meetings relevant to the assigned asset(s);
Support the generation of training materials and presentations at study-specific investigator meetings and internally.

PROFILE:

You have a doctoral degree (MD, PhD, or PharmD or equivalent) and 7+ years of clinical, scientific and/or drug development experience in the biopharmaceutical industry, healthcare, academia, or a related environment;
You have demonstrated your leadership and problem-solving abilities;
You have previous experience in participating in or leading cross-functional development teams;
You have experience working on study concept and protocol design, familiarity with regulatory filings, and clinical publications;
You possess deep knowledge of ICH – GCP;
An experience in hepatology is preferred;
You are able to work efficiently in a multidisciplinary team to cultivate an inclusive environment with a respectful, open dialogue to foster the robust sharing of ideas and creative problem solving;
You possess excellent verbal and written communication skills with the ability to effectively engage various stakeholders;
You possess strong analytical skills and and strategic thinking to formulate, develop, and execute clinical development plans;
You are able to critically evaluate scientific literature to help maintain thought leadership and inform clinical strategy;
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.