Your mission
We are looking for an experienced and strategic Medical Director (m/f/x) to provide medical leadership for a mature global Phase 3 program in relapsing Multiple Sclerosis. In this role, you will combine deep strategic understanding of MS clinical outcomes with hands‑on medical monitoring expertise to support the successful execution of a registrational study, evaluating safety and efficacy.
* Clinical Strategy & Leadership: Lead the unblinding, data review, and readout of two Phase 3 clinical trials in relapsing MS, including comprehensive data analysis and interpretation. Provide medical leadership for Clinical Study Reports.
* Regulatory Interactions: Support and participate in pre‑NDA regulatory activities (FDA, EMA), ensuring clear communication of clinical outcomes and study rationale.
* Scientific Expertise & External Engagement: Collaborate closely with the medical advisory board and key investigators, and represent the program at scientific and medical conferences.
* Cross‑Functional Collaboration: Work with our NDA preparation team to shape key messages, clinical summaries, and data presentations across NDA modules.
* Data Interpretation: Evaluate high‑level Phase 3 results to support global registration, reimbursement strategies, and scientific publications.
* Medical Trial Oversight: Provide hands‑on medical monitoring for the ongoing Phase 3 trial, including review activities during data cleaning.
* Pharmacovigilance Support: Partner with the Pharmacovigilance team on medical assessment of safety cases, including review and preparation of narratives for serious adverse events (SAEs).
* Leadership in Regulatory Interactions: Serve as a medical leader in planned interactions with regulatory authorities, ensuring alignment on clinical evidence and program strategy.
Your profile
* Medical Degree (MD), ideally with training or clinical background in neurology, or advanced degree in science or related field.
* 3-5+ years of experience in biotech or pharma industry or in academic clinical research within late‑stage trials.
* Previous involvement in Phase 3 clinical trials is required.
* Expertise in Multiple Sclerosis, with scientific understanding of disease mechanisms and clinical development pathways of advantage.
* Solid knowledge of Good Clinical Practice (GCP) and international regulatory requirements (FDA, EMA).
* Experience in assessing risks, opportunities, and implications in late‑stage drug development.
* Ability to lead and collaborate effectively in cross‑functional and matrix team structures.
* Excellent communication skills and a strategic mindset.
* Native‑level English proficiency.
Why us?
We offer
* A permanent position in an international and highly motivated team.
* A dynamic, flexible and innovative working environment.
* Participation in our company’s success through our stock option program.
* Competitive compensation, comprehensive benefits and opportunities for professional growth.
* Further benefits that promote our employee’s health and well‑being: Wellpass, OpenUp, and more.
Join us and be part of a company where your work directly contributes to our mission of improving
patient care through groundbreaking research. Immunic AG offers a stimulating work environment where
innovation and collaboration are valued.
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