Clinical Research Scientist

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Clinical Research Scientist November 2018 Antabio is a Labège, France‐based biopharmaceutical company dedicated to the discovery of first‐in‐class small molecule compounds to treat severe infections caused by antibiotic‐resistant bacterial pathogens. Antabio’s novel compounds block the drug‐resistance mechanisms and the virulence of pathogenic bacteria by targeting key bacterial pathways. Using its patented technology, antibacterial discovery expertise, and partnering‐oriented business strategy, Antabio advances novel drugs that will offer solutions to the shortfall of the current antibacterial arsenal. Antabio is advancing its metallo beta‐lactamase inhibitor program for the treatment of resistant Gram‐negative infections towards the clinic and is the recent recipient of a grant from CARB‐X to develop a novel treatment for Pseudomonas infections in CF patients. Antabio is seeking a Clinical Research Scientist to join our R&D team to set up and co‐ordinate future clinical trials under the responsibility of our Chief Medical officer Requirements Master’s degree (or equivalent) with in depth experience of Phase 1 clinical development ≥ 3 years relevant experience in the pharmaceutical and/or biotech industry Experience in the set‐up, conduct, and operational oversight of clinical studies conducted by CROs Experience with regulatory submissions including CTAs, INDs, and/or IMPDs Experience with first in human studies for NCEs/NBEs preferred Experience in Infectious diseases would be beneficial Medical writing experience ideal Fluent Oral and written English mandatory Able to work in globally distributed company environment Flexible with regards to work/home location, with regular onsite (Toulouse) meetings required Responsibilities Provide operational oversight to Clinical trials from Phase 1 to Phase 3, including sites located in the EU, North and South America, Australia and rest of Asia Excellent oral and written communications skills, including proven history of positive interactions with clinical study sites and CROS as the clinical operations representative of the sponsor Hands‐on management and responsibility for all CRO activities with respect to operational aspects of protocols, case report forms, data management plans, safety monitoring plans, and data review Responsible for participating in the development and authoring of clinical study protocols, informed consents, clinical study reports, investigator brochures, and regulatory submission documents ANTABIO 1 Biostep, 436 rue Pierre et Marie Curie, 31670 Labège, France Phone (+ 33) 5 31 47 18 57 • Fax (+ 33) 5 31 47 18 50 • [email protected] Assess the operational capabilities of CROs to conduct clinical trials for Antabio Ability to independently oversee and coordinate activities with CROs Effective collaboration with medical monitor and remainder of the project team Collaboration with drug supply coordinator, PK lab, and other vendors as required Ability to provide high quality review of study data Proactively identify potential study conduct issues and define appropriate solutions in collaboration with medical monitor Participate in cross‐functional team meetings and meetings with CROs and vendors, as required Manage clinical trial budgets in collaboration with the Antabio medical monitor and project manager ANTABIO 2 Biostep, 436 rue Pierre et Marie Curie, 31670 Labège, France Phone (+ 33) 5 31 47 18 57 • Fax (+ 33) 5 31 47 18 50 • [email protected] .

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