Description: This role will be responsible for successfully leading all clinical operational aspects of phase II, III and IV global clinical trials and has expertise in multiple therapeutic areas and specific expertise in Central Nervous System indications. Provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance. Responsibilities also include leading and assisting with creation of essential project documents, such as protocols, CRFs, ICFs, operation manuals, monitoring plans, SOPs, development plans, safety updates, and clinical study reports. Essential Functions: + Under the guidance of the Vice President of Clinical, establish timelines, goals, and objectives, and ensure projects are executed successfully and on schedule. + Provide leadership support in selecting a Clinical Research Organization (CRO), negotiating proposals, and establishing clear deliverables. + Manage staff in accordance with the organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance and guiding professional development. + Responsible for the oversight of project budgets and ensure adherence to the overall department budget as well as timelines. Analyze and review budgets for clinical studies. Proactively plan for appropriate clinical operations budget consumption and guide project managers and CRA's in managing variances and in developing corrective fiscal action plans + Lead on weekly CRO/Internal team communications and progress reports. Coordinate discussions regarding project risks and strategies with CROs, including but not limited to recruitment, site issues, etc. Participate in meetings with CRO Executive Team when required. Provide clinical input for regulatory and safety documents and interact directly with senior management on program progress. Provide internal support with the monitoring of clinical trial data and issues associated with the data. + Primary contact for CRO legal and Internal legal for Clinical Trial Agreement negotiation/ escalation and for Letter of Indemnification negotiation/escalation. As well, for CRO study start-up team for clinical site budget escalation. Review CRO invoices against statement of work and ensuring accuracy. Primary contact for CRO Clinical Trial Manager, Project Manager. Back-up contact for site personnel Additional Responsibilities: + Strong leadership and communication skills are required, and the ability to champion a portfolio of programs. Proficiency at finding and implementing creative solutions, and exceptional time management and with proven project management skills required. Experienced in successfully leading and managing a team of direct reports.