Study Manager

Starting with ophthalmology, Coave Therapeutics is redefining targeted gene therapy by solving its most critical challenge: delivery. The Company is pioneering first-in-class ligand-conjugated AAVs, enabling precision vectors that are highly tissue specific, precisely delivered and safer than traditional approaches.

Through its targeted gene therapy approach, Coave has created the first suprachoroidal vector, which has the potential to transform the treatment of retinal vascular diseases such as nAMD and DME. Coave is advancing its lead program, CoTx-101, towards clinical development, with the goal of delivering a best-in-class, durable and convenient treatment that frees patients from the burden of frequent injection while providing durable vision gains.

Coave's plug-and-play technology can be applied to any vector or payload, enabling exploration of prevalent indications previously considered unthinkable with traditional gene therapy approaches.

Headquartered in Paris, France, Coave Therapeutics is backed by leading international life science investors. For more information, please visit

Position overview

The
Study manager Translational
plays an important role in the development of Coave's therapeutic programs by conducting IND-enabling preclinical studies that bridge Coave's gene therapy lead candidates to clinical development. He/She is responsible for designing, planning and implementing IND-enabling preclinical studies including distribution and toxicology profile of our therapeutic products required to support clinical study authorization. The individual ensures that studies, outsourced to contract research organizations (CROs), are executed correctly, on time, within budget and with the quality standards to meet regulatory requirements.

Job responsibilities

·       Design and implement IND-enabling preclinical studies (GLP and non-GLP) including biodistribution, toxicology and safety of Coave's products to support therapeutic programs development.

·       Draft or review study protocols, ensuring scientific robustness and alignment with regulatory expectations. Manage the selection and qualification of CROs, and handle all related agreements (e.g., service agreement, scope of works…).

·       Monitor the progress of the studies, ensuring that studies are conducted as planned, and that CROs meet agreed-upon milestones.

·       Ensure reliance of scientific data analysis and review of the study reports. Review raw data, interim updates, and final reports with a critical scientific eye.

·       Coordinate development, validation, and qualification of new bioanalytical methods (e.g., qPCR/ddPCR, immunoassays) required for IND-enabling studies.

·       Proactively identify and resolve issues related to study execution, including delays, budget overruns, or quality concerns.

·       Ensure that studies are compliant with all relevant regulations and quality standards.

·       Ensure compliance with therapeutic program timeline & budget, and that deliverables align with program's goals.

·       Maintain comprehensive records of study protocols, data and reports.

·       Communicate, collaborate, and coordinate effectively with other Coave teams.

·       Contribute to the preparation of documents for regulatory filings.

Education

Ph.D. in life sciences, biotechnology, or a related field

Languages

·       Fluent English – written and spoken

·       French is a plus

Experiences / Professional requirements

·       Minimum 5 years of experience in preclinical in vivo research and/or translational development.

·       Hands-on experience in ophthalmology animal studies required

·       Experience in gene therapy, preferably within the biotech or pharmaceutical industry is a plus.

·       Understanding of preclinical study design and experience in managing CROs, including vendor selection, study management, and contract negotiation is required.

·       Experience with non-human primate studies is a plus.

Competencies

·       Critical analysis of data and troubleshooting abilities.

·       Rigorous.

·       Strong organizational skill.

·       Ability to manage multiple projects and priorities simultaneously.

·       Highly collaborative working style, and ability to adapt in a fast-paced environment.