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o Assist in the development and implementation of global clinical research strategy in order to meet key business objectives of the company. Direct and oversee all aspects of clinical operations for the successful execution of multiple single and multi-center clinical studies for submission, scientific, and marketing purposes. This includes strategic and operational leadership relative to the direction, planning, execution, and conduct of clinical studies. Ensure all studies are conducted in compliance with all applicable regulations and SOP's, and in accordance with study timelines and budgets. Provides functional leadership, management and development to other staff in the clinical affairs department including Clinical Trial Managers, Clinical Trial Associates, and Clinical Affairs Coordinators. o Participates in cross-functional teams in the development of clinical program strategy. o Coordinates resources in order to meet company goals and objectives. o Responsible for the development and management of clinical studies which includes timelines, budgets and resource requirements. o Coordinates the development of study protocols and oversees the development of related support documentation such as monitoring plans, case report forms, contracts, study site informed consent approvals, and database development. o Overall responsibility for consistency and accuracy of trial information in databases and tracking systems. o Assures that Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs) are followed. o Establishes and maintains relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical study activities. o Oversees vendors responsible for recruiting, screening and selecting competent investigators. o Responsible for auditing of monitoring processes and practices and ensuring site recruitment, initiation objectives, and patient enrollment targets are met. o Organizes investigators' meetings, ad hoc clinical advisory meetings, and other meetings as needed. o Liaises and communicates with Regulatory Affairs, Marketing, Sales and other key functions on project-related issues as part of a cross-functional corporate team. o Forecast trial resources as needed (headcount and external costs) for program. Accountable for the development, management and tracking of budget and management of payments and timelines to ensure trial execution is within budget and on time. o Develops and assures accurate reporting and measurement of progress for various studies within a clinical program. o Assumes responsibility for career development plans of any direct reports and actively ensures that they receive appropriate management and technical support and training. o Assigns projects and priorities to the Clinical Affairs team. Qualifications