The Director - Clinical Scientist will be responsible for leading activities related to trial design, execution, and analysis of clinical trials, with a focus on Rare Diseases. This role involves representing and monitoring clinical data, responding to regulatory queries, and serving as the subject matter expert on assigned protocols while addressing potential issues. The primary responsibilities include leading the creation of clinical development plans, study synopses, and protocols, as well as monitoring trial data for quality, managing tasks by external vendors, and maintaining GCP compliance. Additionally, the Director will contribute to regulatory briefing packages, responses, and development for major regulatory submissions, offer clinical and scientific input into regulatory documents and study reports, and ensure effective training and communication with study site staff. They will also represent clinical science in management teams and prepare presentation materials for various stakeholder meetings.
Overall, the Director - Clinical Scientist will play a key role in driving the clinical development of Rare Disease treatments by providing clinical and scientific input, ensuring compliance with regulations, and effectively communicating with internal and external stakeholders. This position requires strong leadership skills, the ability to manage multiple tasks and vendors, and a deep understanding of clinical trial design and execution. The successful candidate will have experience in clinical development, regulatory submissions, and GCP compliance, as well as excellent communication and presentation skills. They will also be able to work effectively in cross-functional teams, provide strategic input into clinical development plans, and represent clinical science in various meetings and discussions.