Sobi - Swedish Orphan Biovitrum AB (publ)

Clinical Research

• Provide clinical, scientific and strategic input to clinical development plans for assigned sepsis programmes
• Define target populations, immune phenotypes/endotypes and biomarker-based enrichment strategies
• Select clinically meaningful primary and secondary endpoints
• Evaluate adaptive, platform and Bayesian trial design options
• Collaborate on overall scientific and medical development strategy
• Act as clinical scientific lead for assigned Sobi-sponsored studies
• Where formally delegated and medically qualified, act as Medical Director/Medical Monitor
• Plan, design, conduct, medically monitor and report Sobi-sponsored studies
• Author clinical study protocols and clinical study reports
• Contribute to statistical analysis plans, informed consent templates and other core study documents
• Support operational feasibility in intensive care and emergency department settings
• Review emerging safety and efficacy data and support adverse-event attribution, safety review committee and DSMB interactions, and interim analyses
• Participate in investigator meetings, site training and study-related activities
• Provide expertise in regulatory-authority interactions and clinical components of regulatory submissions
• Contribute to responses to Health Authority questions, scientific advice, IND applications and marketing authorisation applications
• Engage with key opinion leaders and support or lead advisory boards
• Represent Sobi at international conferences and scientific symposia
• Support engagement with scientific societies, research networks and patient advocacy organisations
• Provide scientific and medical expertise to Global Safety, Medical Affairs and Business Development
• Build current knowledge in sepsis, critical care and immune dysregulation
• Develop relationships with cross-functional teams, local affiliates and collaborative partners
• Work according to applicable rules, regulations and internal procedures

Clinical Scientist, Sepsis