Associate Director, Medical Information & Medical Review

We are seeking an experienced Medical Affairs professional to help build Medical Information and Medical Review capabilities s individual will serve as a trusted scientific resource for healthcare professionals, patients, and internal stakeholders regarding vidofludimus calcium and Immunic’s broader pipeline while helping ensure the scientific and clinical integrity of internal and external communications.

The Associate Director will serve as the Medical Information and Medical Review subject‑matter expert, with primary accountability for scientific content quality, evidence interpretation, response development, and medical review judgment, while partnering closely with Medical Affairs Operations on process design, systems, vendors, metrics, and execution.

As one of Immunic’s first dedicated leaders in these areas, this individual will help shape scalable capabilities from the ground up while remaining hands‑on in high‑priority scientific writing, inquiry response, medical review, and launch‑readiness activities.

• Build core Medical Information capabilities, including response standards, scalable processes, and readiness plans aligned with Medical Affairs priorities, regulatory milestones, and potential launch.
• Serve as a trusted scientific and clinical resource for internal and external medical inquiries regarding vidofludimus calcium, multiple sclerosis, and Immunic’s broader pipeline.
• Establish scalable processes for intake, triage, documentation, response, escalation, and analysis of unsolicited medical and scientific inquiries from healthcare professionals, patients, caregivers, and other stakeholders.
• Develop and maintain accurate, balanced, evidence‑based, and appropriately referenced Medical Information resources, including standard response documents, FAQs, medical information letters, and custom responses.
• Partner with Medical Affairs Operations and external vendors or contact centers to support timely response delivery, training, quality oversight, issue escalation, and performance monitoring.
• Partner with Pharmacovigilance and Quality to ensure appropriate identification and escalation of adverse events, product complaints, and other reportable information received through Medical Information channels.
• Analyze inquiry trends, emerging stakeholder needs, and Medical Information insights to inform Medical Affairs planning, congress readiness, field resources, and broader scientific communication priorities.

• Serve as a senior medical reviewer for promotional and non‑promotional materials across applicable review pathways.
• Evaluate materials for scientific and clinical accuracy, balance, context, evidence support, and alignment with product development or labeling status.
• Review the presentation and interpretation of clinical, safety, statistical, mechanistic, and health‑outcomes data, including appropriate communication of limitations, uncertainty, and exploratory findings.
• Provide clear, actionable, risk‑based medical review comments and partner cross‑functionally to resolve issues and support timely material approval.
• Help establish practical Medical Review standards, guidance, documentation practices, escalation pathways, and quality controls that improve consistency, rigor, and review efficiency.
• Maintain appropriate distinctions among non‑promotional scientific communication, responses to unsolicited medical inquiries, corporate communication, and promotional communication.

• Serve as an internal subject‑matter expert for Medical Information and Medical Review, providing strategic recommendations, independent scientific judgment, and practical guidance across the organization.
• Develop…