Clinical Research Director
il y a 5 jours
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).
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, the preparation and participation of advisory board meetings;
- Contribute clinical content to development of the clinical trial statistical analysis plan in collaboration with biostatistics 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 reviewing 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;
- 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 GENFIT 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 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.
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