Operations

• Responsible for the development and execution of the clinical development plan and has ownership for the design of clinical trials and for the content of clinical study reports
• Leads Cross-functional Clinical Team; supervises, develops and recruits junior medical staff
• Molecule responsible physician; Responsible for the oversight of medical monitoring/reporting and safety activities; Evaluates adverse events (pre and post-marketing) for relationship to treatment.
• Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed
• Interprets, reports and prepares results of product research in preparation for global health authority submissions and external communication
• Responsible for assessment of medical publications emerging from the Team and its affiliates
• Assists Regulatory Affairs in the development of drug/device regulatory strategies and determining requirements for any corrective actions or health authority reporting
• Acts as medical contact at company for global health authorities concerning clinical/medical issues
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
• Supports early clinical development involving product potential and development for registration
• Manages the budget for all project related clinical activities

Senior Director, Clinical Leader – Neuropsychiatry

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Operations Specialist

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