
Senior Director – Translational Medicine, Pharmacology
Posted 5 hours ago

Posted 5 hours ago
This is a fully remote position, open to applicants in United States.
• Lead the strategy for translational medicine and pharmacology across Immunic's pipeline, with an initial focus on the Phase 3 vidofludimus calcium program for both relapsing and progressive multiple sclerosis.
• Design and manage pharmacodynamic, efficacy, safety, and patient-stratification biomarker strategies that are integrated into clinical trial protocols.
• Collaborate with Clinical Development, Clinical Pharmacology, and Biostatistics to convert preclinical pharmacology data into clinical dosing rationale and study design.
• Act as the scientific lead for mechanism of action, PK/PD modeling, and exposure-response analyses to support clinical and regulatory decision-making.
• Work alongside Regulatory Affairs on the translational and pharmacology sections of IND/CTA submissions, briefing documents, and BLA/NDA packages.
• Support and represent the organization in meetings with FDA and EMA health authorities, as well as responding to agency inquiries.
• Collaborate with Discovery and Preclinical teams to guide the selection and advancement of early-stage pipeline assets.
• Partner with Medical Affairs and Clinical Development to contribute to translational publications and conference presentations.
• Establish relationships with MS experts, translational researchers, academic institutions, and key opinion leaders within the fields of immunology and neurology.
• Contribute to business development efforts by assessing in-licensing opportunities and aiding in scientific due diligence.
• Assist in the development and mentorship of a translational medicine function.
• MD/PhD is required.
• A minimum of 12 years of experience in translational medicine, clinical pharmacology, or a related field within the pharmaceutical or biotechnology industry.
• Proven experience in neurology, immunology, and/or autoimmune diseases, particularly with a focus on multiple sclerosis.
• A successful track record of implementing biomarker and translational strategies to advance programs from clinical development to regulatory submission.
• Extensive knowledge of PK/PD modeling, exposure-response analysis, and the regulatory expectations of FDA/EMA for translational data packages.
• Experience in leading or supporting interactions with health authorities on translational and pharmacology topics.
• Strong cross-functional collaboration capabilities, with the ability to influence without direct authority in a matrixed setting.
• Exceptional written and verbal communication skills, with experience in presenting to executive leadership and scientific audiences.
• Comfort in a small-company environment that demands a high degree of autonomy and accountability, and the ability to navigate ambiguity.
• Willingness to travel internationally, including occasional trips to Immunic's operations in Germany.
• Authorization to work in the US.
• Equity.
• Bonus.
• Willingness to travel internationally, including periodic travel to Immunic's operations in Germany.
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