Principal Clinical Scientist

United States of AmericaR-0577762012 CSL Behring L.L.C.

Job Description

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.