Director, US Medical Affairs Operations

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The Director, US Medical Affairs Operations will work closely with all US Medical Affairs (USMA) functions to provide operations support to all critical projects. 

Key Accountabilities/Responsibilities:

• Lead USMA Medical Operations Function and Community serving operational needs for US Medical Affairs HQ and Field Teams to provide support on all Medical Affairs projects
• Lead the USMA Medical Operations Team including the recruitment, development and management of Field Operations, Medical Operations, and Vendors
• Partner with Medical Affairs functions to manage Medical Affairs projects including project milestones, contracts and budgets, advisory boards and steering committees, regional congresses, quarterly business reviews, quarterly budget analysis, strategic & tactical planning, and project management of assigned medical team meetings including Strategy, Leadership and Matrix meetings and USMA system implementation/management such as Veeva CRM
• Responsible for the logistics, financial administration and documentation of project orders with external collaborators and consultants.  Oversee strategic partnerships, budget tracking, PO creation, & budget reconciliation for KOL and medical affairs-related work
• Lead and oversee Field Operations for all Medical Director and Field Team activities including Regional Round Tables, Regional and National Advisory Boards, and KOL Lecture programs
• Lead and manage Financial Operations for management of all procurement activity including SOW review and approval, purchase requisition and purchase order processing, invoice review, reconciliation and processing. Communication with internal stakeholders and strategic partners about various project milestones, payment, etc.
• Lead and manage preparation of agendas, pre-meeting materials and coordinate meeting travel and scheduling as needed for Medical Affairs Leadership meetings
• Liaise with Compliance on behalf of USMA for annual needs assessment, business justification forms, and field activities
• Liaise with Med Affairs functions to support Statement of Work (SOW) submissions, CDA and Consultancy Agreements
• Complete all work in accordance with regulatory requirements, industry standards, and argenx policies

Desired Skills and Experience:

• Able to effectively network and partner with internal and external stakeholders and facilitate/promote cross-functional collaboration
• Strong operational capabilities, eye for detail and commitment to advance and adhere to processes
• Able to manage and develop a team of Medical Operations professionals to support USMA field and HQ activities.
• Understand and demonstrate the importance of providing superior customer service to all internal and external stakeholders to support the business
• Excellent communication skills: verbal and written
• Able to thrive as part of a team and when working independently
• Proven track record of delivering results that meet or exceed targeted objectives
• Detailed understanding of industry regulations and practices relating to Medical Affairs
• Experience in collaborating with others to bring tasks/projects to completion
• Excellent planning and organizational skills
• Able to handle multiple tasks and deadlines

Education and Qualifications:

• Bachelor’s Degree.  Advanced degree (MS, MBA, MA) preferred
• 8+ years industry experience, working in Medical Affairs, supporting medical affairs operations
• Knowledge of Veeva CRM, Tableau, PowerPoint, Excel, Smartsheet, SharePoint
• Understanding of pharmaceutical development and commercialization
• Experience with Project and Portfolio Management (PPM) tools, dashboards and reports

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