Overview In this Clinical Scientist role, you lead design, execution and reporting for Sobi-sponsored sepsis studies, acting as a scientific expert across development, regulatory and safety domains. You will shape target populations, endpoints and trial designs in a high-need, complex patient population. You collaborate with cross-functional teams to translate early concepts into pivotal clinical development, shaping strategic decisions and external scientific engagement. This role offers impact in advancing sepsis therapies within a mission-driven biopharma environment. Verantwortungsbereiche Provide clinical development strategy and study design input for the sepsis programme, including target population, endpoints and enrichment strategies Act as clinical scientific lead and Medical Director/Monitor for assigned studies; plan, conduct and report studies with cross-functional collaboration Contribute to regulatory interactions and submissions; provide scientific input to regulatory responses and health authority questions Engage with external experts, lead advisory boards and represent Sobi at conferences and with scientific societies Support cross-functional HQ functions (Safety, Medical Affairs, Business Development) with medical and scientific expertise Develop and maintain current knowledge in sepsis, critical care and immune dysregulation; foster cross-functional relationships Ensure adherence to ICH-GCP and regulatory requirements; uphold scientific and ethical standards Zentrale Anforderungen Medical degree (MD) with relevant specialization, or PhD/PharmD with equivalent clinical development experience Documented record in drug development translating early programmes into the clinic Working knowledge of ICH-GCP and trial regulations; understanding sponsor obligations for protocol design, monitoring and reporting Strong written and verbal communication; credible representation at international venues Excellent organizational and project management abilities Ability to lead and influence cross-functional teams without direct line authority Knowledge of clinical trial design in acute critical care; adaptive, platform and Bayesian approaches Biomarker-guided patient selection and enrichment strategies Pharmacokinetics/pharmacodynamics in critically ill patients; altered PK concepts
Clinical Scientist, Sepsis Arbeitgeber: Swedish Orphan Biovitrum
Als Arbeitgeber bieten wir Ihnen die Möglichkeit, in einem dynamischen und internationalen Umfeld zu arbeiten, das sich auf den Zugang zu spezialisierten Gesundheitsprodukten konzentriert. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und zum Networking mit verschiedenen Stakeholdern bieten. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einer positiven Work-Life-Balance, die es Ihnen ermöglichen, Ihre Karriere und Ihr persönliches Leben in Einklang zu bringen.
