SummaryWe are seeking an experienced Medical Affairs professional to help build Medical Information and Medical Review capabilities at Immunic. This 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.
ResponsibilitiesMedical Information- 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.
Medical Review- 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.
Functional Leadership and Capability Building- 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 and maintain fit-for-purpose SOPs, work instructions, templates, content standards, and controlled processes in collaboration with Medical Affairs Operations, Quality, Regulatory Affairs, and Legal and Compliance.
- Partner with Medical Affairs Operations to define scientific and business requirements for systems, vendors, metrics, and workflows, and provide SME input to support implementation, quality oversight, and continuous improvement.
- Translate Medical Affairs priorities into clear scientific deliverables and readiness milestones that support late-stage development, regulatory submission, and potential launch.
- Identify scientific, content-quality, operational, or compliance risks; recommend solutions; and escalate significant issues appropriately.
Qualifications & Education- PharmD, MD, PhD, or another relevant advanced scientific or clinical degree with relevant experience.
- At least six years of progressive experience in Medical Information, Medical Review, Medical Communications, Medical Affairs, or a closely related function within the biotechnology or pharmaceutical industry.
- Demonstrated hands-on experience developing and maintaining standard response documents, frequently asked questions, medical information letters, custom scientific responses, or similar Medical Information resources.
- Experience responding to unsolicited medical and scientific inquiries from healthcare professionals, patients, or other external stakeholders.
- Demonstrated experience conducting medical review of promotional and/or non-promotional materials within a cross-functional review process.
- Exceptional scientific writing, literature interpretation, evidence evaluation, and medical review skills, with demonstrated ability to produce and evaluate accurate, balanced, evidence-based, and appropriately referenced medical content.
- Working knowledge of applicable requirements and industry standards governing Medical Information, scientific exchange, responses to unsolicited inquiries, medical review, and pre-approval and promotional communications.
- Experience partnering effectively with Medical Affairs, Clinical Development, Regulatory Affairs, Legal and Compliance, Pharmacovigilance, Commercial, and external service providers.
- Demonstrated ability to exercise independent judgment, identify and manage risk, make well-reasoned recommendations, and escalate issues appropriately.
- Strong organizational skills and the ability to manage high-quality scientific deliverables across multiple priorities; experience partnering with project-management, operations, vendor, or systems teams is preferred.
- Comfort operating in a growing, pre-commercial biotechnology organization where processes are being developed and priorities may evolve.
