Establish and execute clinical development activities for an innovative biologic, including identification of process gaps and ensuring sponsor readiness for the first Phase I study * Coordinate the development of key study documents such as the Protocol, Investigator's Brochure, SAP, and the Clinical Study Report - With efficient structures, short decision‑making paths, and a high degree of autonomy, Orpha Trade is preparing to launch a Phase I study for a novel biologic. This role offers the opportunity to build Clinical Operations from a greenfield setup and to significantly shape the clinical development program. * Build the Clinical Operations structure and further develop existing SOPs and processes * Develop and implement GCP-compliant clinical trial management processes to support an efficient sponsor organization
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