Associate Director Jobs

About The Position

Requirements

• 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.

Responsibilities

• 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 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.