Sylvia Dobo Email Address

Executive Director of Product Safety and Clinical Development

BioCryst has over 80 employees spread across their two locations in Birmingham, Alabama and Durham, North Carolina.

Seasoned clinical development and pharmacovigilance physician with broad experience in both the marketed and pre-marketed arenas. Strategic program planning, protocol development, regulatory interactions, benefit risk assessment, signal detection and signal analysis are particular strong suites. Significant experience with international and inter-cultural partnerships including Europe, Japan and Australia. Key role in multiple NDA, BLA, PMDA and EMA approvals. Experience with pediatric drug development and PIP approval. Excellent writing and presentation skills leading to accurate decision making by internal and external audiences. Proven successful interactions with regulatory bodies both via written response and face to face meetings. Additionally, extensive experience in data review and analysis of efficacy data as well as safety data. Specialties: Strategic drug/biologic development, Protocol development, Pharmacovigilance, KOL interaction, Medical monitoring, Benefit-risk assessment, Signal detection and assessment, Data mining, Safety operations and ICSR processing,