Principal Clinical Scientist
The Principal Clinical Scientist will work closely with the Senior Global Clinical Program Director and Director Clinical Development Scientist to drive the clinical development program as dictated by therapeutic area/ project needs. The position holder is responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols, Investigators Brochures, clinical study reports, conference abstracts, internal and external scientific meeting presentations and peer-reviewed publications.
Requirements:
The Principal Clinical Scientist, Gene Therapy will
•Contribute to the scientific development of individual clinical studies in alignment with the approved clinical development plan, including authoring and reviewing clinical documents (eg., protocols, eCRFs, ICFs, SAPs?, CSRs).
•Contribute to the clinical oversight and medical review in collaboration with the Director Clinical Scientist and Senior Program Director during the conduct of the study.
•Review clinical data with some assistance and contribute to the development of clinical presentations and integration of analyses into clinical documents.
•Assist in analyzing and interpreting data from clinical studies, and writing/editing or reviewing results in study reports, regulatory submissions, abstracts, posters, presentations, peer reviewed manuscripts, and other documents.
•Manage the processes required to support internal/external study review committees; e.g independent data monitoring committees, steering committees.
•Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, commercial, and regulatory affairs) to ensure translation of the clinical protocol into operational deliverables.
•Develop and maintain relationships with clinical investigators, consultants, medical educators, clinical research organizations (CRO), affiliated hospitals, state and/or government hospitals, research institutions and patient advocacy groups to plan, initiate and expedite clinical studies.
•Provide input for Regulatory Submissions.
