FSP Sr. Clinical Scientist - Immunology

Job description

Senior Clinical Scientist, FSP – Immunology – Remote US or Canada *** Position leads Phase 1-3 Clinical Trials and oversees medical monitoring. This is not a laboratory/research scientist role . *** In this role, the selected candidate will lea d/support studies; be accountable for the clinical/scientific execution of the protocol; be the clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) ; and act as scientific lead on Clinical Trial Team (CTT) . Responsibilities include: Responsible for trial design and endpoint development in collaboration with CD ; collaborates with medical writing to develop trial results communication for investigators Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports , monitoring data issues and central lab reports Sets up/supports SAC, DMC, adjudication committee ; provides scientific input to SM for data management activities ( e.g. EDC, DRP, CRF’s_ Protocols/amendments – collaborates with medical writ ing , participates in governance committee review ; authors protocol clarification letters...