Medical Director

• Serve as the project physician and provide medical and scientific expertise to project teams.
• Ensure accuracy and integrity of trial data with concentrated focus on patient safety.
• Work closely with senior leaders in Medical, Operational Strategy, and Business Development to support client engagement.
• Support Business Development and Proposals teams: participate in RFP process, prepare medical considerations for proposals, support/participate in bid defense meetings.
• Write or edit scientific content of deliverables within budget and timelines; create content for white papers and publication manuscripts.
• Collaborate with Regulatory Affairs on regulatory product landscape and drug development strategies.
• Review and revise protocols, case report forms, training materials, project tools, analysis plans, study designs, clinical trial reports and new drug applications.
• Review laboratory values, adverse events, coded adverse event and medication data, and data tables, listings and figures as needed.
• Serve as a medical resource for study sites, the project team and clients; assume responsibility for medical and safety monitoring on assigned projects.
• Assist in preparation of the Medical Monitoring Plan and materials for investigator meetings and staff training sessions.
• Participate in feasibility discussions related to specific project proposals and develop disease-state training modules.
• Participate in process improvement activities and collaborate with VP, Global Medical to support global Medical Science Department growth.

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