Head of Medical Information (Director/Senior Director) – Medical Affairs

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 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,
• 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 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.
• Senior Director level: 12+ years of relevant experience in MI or related MA roles within the pharmaceutical or biotechnology industry, with at least 3 years of management or team leadership experience managing direct reports and/or matrixed teams.
• Demonstrated ability to build, lead, and inspire high-performing teams.
• Executive presence, 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.

Benefits

• Comprehensive health coverage,
• Flexible paid time off,
• Generous parental leave,
• A competitive 401(k).

About the Role

• Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
• Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
• Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome.
• Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.