Head of Medical Information (Director/Senior Director) – Medical Affairs
Core
Lead the Medical Information (MI) function to build operational infrastructure, ensure regulatory compliance, and manage scientific responses for a dual BAFF/APRIL inhibitor treating autoimmune diseases.
Role type
Director/Senior Director, Medical Information (Medical Affairs)
Builds
Global MI operational infrastructure, Standard Response Documents (SRDs), and compliant inquiry management systems for a Phase 3 autoimmune therapy.
Domain
Biotechnology / Autoimmune disease (telitacicept)
Deliverable
client delivery
Required skills
US regulatory framework knowledge, global MI strategy development, team leadership and mentorship, SOP and governance document creation, pharmacovigilance integration, data management compliance, scientific acumen in autoimmune space, project management, cross-functional stakeholder engagement.
Preferred skills
Experience with ex-US regulatory frameworks, multi-country MI operations, immunology/rare disease domain expertise, managing outsourced MI operations.
Technologies
Power BI, Tableau, Excel, medical CRM, document management systems, inquiry tracking platforms
Responsibilities
Lead end-to-end buildout of the MI function (team, technology, content, SOPs, vendors); Develop and execute global MI strategy; Establish operational infrastructure and escalation pathways; Ensure global compliance and integration with safety databases; Develop and maintain SRD libraries and governance; Drive implementation of emerging technologies; Lead, mentor, and develop high-performing MI teams; Establish MI quality assurance programs; Partner with cross-functional teams for product launches; Monitor inquiry trends and track KPIs.
Seniority
Director/Senior Director, hands-on IC with management responsibilities
