Medical Director (m/f/x)

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.<br><br><br><ul><li>Clinical Strategy &amp; 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. </li><li>Regulatory Interactions: Support and participate in pre‑NDA regulatory activities (FDA, EMA), ensuring clear communication of clinical outcomes and study rationale. </li><li>Scientific Expertise &amp; External Engagement: Collaborate closely with the medical advisory board and key investigators, and represent the program at scientific and medical conferences. </li><li>Cross‑Functional Collaboration: Work with our NDA preparation team to shape key messages, clinical summaries, and data presentations across NDA modules. </li><li>Data Interpretation: Evaluate high‑level Phase 3 results to support global registration, reimbursement strategies, and scientific publications. </li><li>Medical Trial Oversight: Provide hands‑on medical monitoring for the ongoing Phase 3 trial, including review activities during data cleaning. </li><li>Pharmacovigilance Support: Partner with the Pharmacovigilance team on medical assessment of safety cases, including review and preparation of narratives for serious adverse events (SAEs). </li><li>Leadership in Regulatory Interactions: Serve as a medical leader in planned interactions with regulatory authorities, ensuring alignment on clinical evidence and program strategy.</li></ul>