• Over 16 years Pharmaceutical Industry experienceo Study Coordinationo Clinical Site Monitoro Senior Study Managero Program/Project Managemento Project Planning• Extensive experience in the following Therapeutic Areas: Ophthalmology, Oncology, Cardiovascular, Anti-Infectives, Neuro-Science• Proficient in all aspects of Clinical and Development Operations (Candidate selection through post marketing studies)• Broad understanding of US and ex-US regulatory/ethics requirements

• Generate and maintain project, candidate level plans and project resource forecasts to enable ProjectTeams to meet strategic imperatives• Partner with Project Managers (PMs) and Protocol Leads (PLs) as well as Finance to create project and candidate level plans• Partner with global counterparts to ensure project plans are created in accordance with defined global configuration, standards and speed goals• Work with Study Managers to monitor progress of project activities towards next project milestone(s) and highlight potential variance• Perform scenario planning of timelines and resource demand within and across protocols and acrossthe Therapeutic Area/Portfolio to enable optimal use of local and global resources• Validate resource information at the project level with the project teams• Partner with PMs and PLs to identify opportunities and potential solutions to realize any efficiencies in the development process

• Provide program-wide leadership within a therapeutic area• Serve as primary contact for project team for drug candidates• Promote excellence in implementation of CSDM deliverables• Harmonize consistent processes across entire program• Ensure all CSDM program-wide activities are conducted in compliance with relevant regulatory requirements• Responsible for the recruitment, retention and career development and performance management of CSOM’s• Provide direct input to programs/projects for which I have primary contact responsibilities• Provide support to study managers and data managers and other staff as applicable• Implement strategies to generate grant/budget needs at the program/protocol level• Work with clinical R&D to ensure that all clinical trials are conducted according to the timelines and objectives set forth in the clinical development plan• Work with the therapeutic area heads to promote implementation of consistent processes• Work with the therapeutic area heads to develop charters, resource utilization and project plans to achieve team’s project goals• Through active communication, ensure highly effective cross-functional interactions and processes according to project needs• Work with the development operations team leaders to develop and implement resource strategies for assigned projects• Work with development operations team leaders as primary interface with CRO interactions in fully outsourced studies• Use production and tracking of metrics as a tool to monitor and report the delivery of the clinical studies and data management component on project team goals