Clinical Research Director

GENFIT

Lille, France

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, 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 - 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 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 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).