Director Medical Information – Medical Affairs

The Director Medical Information (MI) will lead the function within Medical Affairs (MA). This senior leader will be responsible for building and running the MI function and preparing for the company’s first regulatory approval and commercial launch. The scope of this role will be primarily US-focused but will also have global responsibilities. As the most senior person in the function the MI lead will be accountable for leading the strategy and operations of the MI function, ensuring accurate, timely, and compliant responses to inquiries from healthcare professionals (HCPs), patients, and internal stakeholders, and be the primary point of accountability with other functions across the company (including, among others, compliance, quality, and safety & pharmacovigilance).

Roles and Responsibilities: 

• Lead the end-to-end buildout of the MI function, covering team, technology, content, SOPs, and vendor ecosystem, in alignment with the company's launch readiness timeline.
• Develop and execute the global MI strategy aligned with company objectives and regulatory standards.
• Establish MI operational infrastructure, including inbound channels, escalation pathways, response turnaround standards, and documentation requirements prior to US launch.
• Ensure global compliance with regulatory requirements and company policies and integration with the pharmacovigilance safety database, medical CRM, and document management system.
• Develop, implement, and maintain all MI governance documents, including standard operating procedures (SOPs) and/or policies and/or working instructions (WIs).
• Oversee development of Standard Response Documents (SRDs) library and content governance. Ensure the creation and maintenance of scientifically accurate, balanced, and up-to-date SRDs and and FAQs.
• Drive the implementation and optimization of emerging technologies.
• Lead, mentor, and develop a high-performing MI team. Foster a culture of scientific excellence, compliance rigor, and continuous improvement.
• Establish and maintain the MI quality assurance program. Ensure MI data management practices comply with applicable data protection regulations.
• Serves as the primary MI representative in cross-functional launch readiness governance. Provide regular MI performance reporting to MA leadership.
• Partner with cross-functional teams including Pharmacovigilance, Regulatory Affairs, Commercial, and IT to support product launches and lifecycle management.
• Monitor and analyze trends in medical inquiries to inform internal stakeholders (e.g., Medical Affairs, Commercial, Pharmacovigilance, Regulatory).
• Develop and track key performance indicators (KPIs) to monitor performance, quality, and compliance of MI services.

Skills and Competencies: 

• Deep knowledge of US regulatory frameworks governing medical information activities,
• Scientific acumen sufficient to lead a global MI function in the autoimmune space
• Excellent project management skills
• Strong cross-functional leadership and stakeholder management skills
• Proficiency with inquiry tracking systems, document management platforms, and data reporting tools (e.g., Power BI, Tableau, Excel).
• Excellent written and verbal scientific communication skills, with experience presenting to executive leadership teams.
• Excellent organizational, managerial, and communication skills
• Key Attributes: proactive, growth mindset, humility, excellence and high emotional intelligence 

Education, Experience and Qualifications: 

• Advanced degree (PhD, MD, PharmD, or equivalent) required.
• Director level: 10 years of experience with at least 5 years of experience in MI or related MA roles within the pharmaceutical or biotechnology industry, with at least 3 years in a management or team leadership experience managing direct reports and/or matrixed teams.
• Demonstrated ability to build, lead, and inspire high-performing teams.
• Excellent organization, communication, presentation, and stakeholder engagement skills.
• Ability to operate effectively in a fast-paced, cross-functional environment.
• Strong knowledge of applicable regulatory guidelines and standards. Familiarity with ex-US regulatory frameworks and multi-country MI operations is preferred.
• Demonstrated leadership of MI functions through at least one product launch.
• Direct experience managing outsourced MI operations and with MI inquiry management platforms.
• Proficiency in scientific and clinical data review and interpretation.
• Experience in immunology, auto-immune disease, and/or rare disease highly desirable. 
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The salary range for the Director Medical Information at Director level is expected to be between $220,000 and $240,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.