The Exec. Director, Global Medical Operations is a highly visible senior leader who will be responsible for providing leadership of global medical shared services including the development and execution of processes and systems that ensure compliant and aligned activities across medical affairs. Responsibilities include leadership of an operations team that is responsible for the effective and efficient coordination of aligned medical affairs activities through strategic planning, vendor contracting, budget tracking, and team performance tracking against goals.

• Lead Global Medical affairs strategic planning process to support creation of an aligned global strategy including clear priorities, tactics, accountabilities, goals, and metrics for tracking progress.
• Manage a high performing medical operations team to support activities at a global, regional, and local level
• Ensure global, regional and country level input into strategic Global Medical Operations activities by acting as an essential interface and conduit to global, regional and local country medical affairs teams.
• Develop, implement and manage ongoing medical strategic initiatives, including vendor contracting, financial oversight of medical budget (AOP), and development of tools/dashboards to measure impact and outcomes of medical activities.
• Coordinate development of key performance indicators across medical affairs including development of a consolidated quarterly medical report and departmental communications plan to ensure ongoing awareness and coordination.
• Provide operational oversight for Grants, Funding and Investigator-Initiated Study (IIS) programs including development of processes (i.e., FMV assessments) that ensure appropriate compliance.
• Oversee planning and logistics for global congress activities
• Actively assesses for potential execution risks and develops mitigation plans.
• Work with management, legal counsel, and site personnel to generate contracts and consulting agreements.
• Provides guidance and leadership in establishing medical affairs systems (CRM, Core Sci Platform, analytics, data visualization) that enable accurate, timely, and compliant communications and reporting.
• Leads and supports efforts to continually improve business practices processes and tools to achieve medical operational excellence
• Establishes and maintains updated relevant policies and procedures to ensure compliance with all corporate and local country standards
• Manage annual budget, work, and allocation of resources, including ensuring contracts, SOWs, and invoices are submitted accurately and in a timely manner
• Support the development and implementation of internal medical communication activities, educational materials, and creation of organizational SOPs addressing processes and procedures as necessary to achieve objectives
• Manage external vendors/medical agencies assisting with medical content planning and execution
• Other duties as assigned and requested by management

• Bachelor’s Degree Required. An advanced degree preferred (MD, PhD, MBA, M.Sci., M.P.H., PharmD, etc)
• Certification as a Medical Publication Professional (CMPP) desirable
• Previous experience managing direct reports is required; management of cross-functional, matrix teams desirable
• Rare disease and/or hereditary angioedema experience strongly preferred
• A minimum of 12+ years’ experience in medical affairs and/or relevant pharmaceutical/biotech industry experience
• Proven leadership skills including ability to collaborate, drive, and execute within a large matrix, cross-functional team
• Excellent written and verbal communication skills, with a proven track record of developing and implementing organization-wide processes
• Ability to travel domestically and internationally approximately 20% of the time