BBOT

Medical Director

• Serve as trial medical lead/medical monitor of assigned clinical studies, including contributing to site selection, study oversight and management plans, CRF design, ICF, enrollment, medical data review, CSR writing, and authoring of clinical modules and clinical review of other modules
• Be a leader within and actively participate and contribute to the cross-functional and project teams meetings, including functioning as clinical representative
• Cultivate relationships with clinical investigators, clinical consultants, and thought leaders for the execution of ongoing trials and developing opportunities
• Help ensure Clinical Study Team compliance with ethical and GCP guidelines, and FDA, EMEA, ICH, and other regulatory requirements relevant to industry/country/region
• Provide expert support for the preparation of clinical/study protocols and amendments, clinical trial documents
• Responsible for the clinical sections of regulatory documents (investigator brochures, development safety update report, etc), clinical study reports
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
• Translate findings from research and nonclinical studies into clinical development opportunities
• Contribute to the clinical portions of writing and preparation of abstracts, presentations, and manuscripts
• Attend key scientific congresses and meetings as requested in support of speakers and key opinion leaders
• Remain current in relevant therapeutic areas and conversant with the literature as well as critical emerging data
• Represent the Clinical Development team during interactions with regulatory agencies, as applicable

Senior Medical Director