Clinical Scientist, Sepsis

Role Overview

Clinical Development and Study Design

• Provide clinical, scientific, and strategic input to development plans for assigned sepsis programmes.
• Define target populations, immune phenotypes, biomarker enrichment strategies, and clinically meaningful endpoints.
• Evaluate adaptive, platform, Bayesian, and other design options and document assumptions supporting sample size and feasibility.
• Collaborate with Medical Development and Medical Program Leads on overall development strategy.

Study Execution and Reporting

• Act as clinical scientific lead for assigned studies and, when formally delegated, act as Medical Director or Medical Monitor.
• Plan, design, conduct, medically monitor, and report Sobi-sponsored studies.
• Author protocols and clinical study reports and contribute to statistical analysis plans, consent templates, and other study documents.
• Support feasibility in intensive care and emergency settings, including emergency consent and biomarker logistics.
• Review emerging safety and efficacy data and support safety committees, DSMB interactions, and interim analyses.
• Participate in investigator meetings, site training, and other study activities.

Regulatory and External Engagement

• Provide expertise in interactions with regulatory authorities and contribute to clinical sections of regulatory submissions.
• Contribute to responses to Health Authority questions, scientific advice, IND applications, and marketing authorisation applications.
• Maintain awareness of regulatory guidance and precedent relevant to acute critical care and sepsis trials.
• Consult with key opinion leaders and support or lead advisory boards.
• Represent Sobi at conferences and engage with scientific societies, research networks, and patient advocacy organisations.

Cross-Functional Support

• Provide scientific and medical expertise to Global Safety, Medical Affairs, and Business Development when assigned.
• Build current knowledge in sepsis, critical care, and immune dysregulation.
• Develop productive relationships with headquarters teams, local affiliates, and collaborative partners.
• Work to applicable scientific, ethical, regulatory, and internal standards.

Required Qualifications

• Medical degree (MD) with relevant specialisation.
• Documented accomplishment in drug development programmes and progression across the clinical development chain.
• Working knowledge of ICH-GCP, applicable clinical trial regulations, and sponsor obligations.
• Strong communication, organisational, project management, cross-functional leadership, and quantitative skills.
• Professional proficiency in written and spoken English.
• Strong integrity, judgement, resilience, and intellectual honesty when interpreting uncertain data.

Desired Qualifications

• Clinical or research experience in intensive care, anaesthesiology, infectious diseases, internal medicine, or emergency medicine.
• Experience in acute or critical care interventional trials, mortality endpoints, adaptive or platform designs, or emergency consent.
• Understanding of sepsis immunology, immune dysregulation, and biomarker-guided patient selection.
• Expertise in pharmacokinetics and pharmacodynamics in critically ill patients.
• Ability to contribute medical and scientific judgement to business development and corporate strategy.

Working Arrangements

• International travel is expected for investigator meetings, advisory boards, site visits, congresses, and Health Authority interactions.
• Occasional out-of-hours availability may be required for urgent medical or safety queries.
• The role is office-based or hybrid with periodic clinical site presence, subject to local Sobi policy.