Clinical Scientist, Sepsis

This is a fully remote position, open to applicants in New York.

📋 Description

• Deliver clinical, scientific, and strategic insights for clinical development plans related to assigned sepsis initiatives.

• Identify target populations, immune phenotypes/endotypes, biomarker-based enrichment strategies, and clinically relevant endpoints.

• Assess adaptive, platform, and Bayesian trial design alternatives and document the assumptions that support sample size and feasibility.

• Collaborate on the overarching scientific and medical development strategy.

• Serve as the clinical scientific lead for Sobi-sponsored studies assigned to you.

• If formally authorized and medically qualified, function as Medical Director / Medical Monitor.

• Plan, design, conduct, medically supervise, and report on Sobi-sponsored studies.

• Draft clinical study protocols and clinical study reports.

• Contribute to statistical analysis plans, informed consent templates, and other essential study documents.

• Support operational feasibility in intensive care and emergency department environments.

• Review emerging safety and efficacy data, assist in adverse-event attribution, safety review committee, and DSMB interactions, as well as interim analyses.

• Participate in investigator meetings, site training, and other study-related activities.

• Offer clinical development expertise during regulatory authority interactions.

• Provide scientific and medical insights for regulatory submissions and responses to Health Authorities.

• Stay informed about regulatory guidance, precedents, and expedited pathways pertinent to sepsis trials.

• Engage with key opinion leaders and support or lead advisory boards.

• Represent Sobi at international conferences and scientific symposia.

• Collaborate with sepsis-focused scientific societies, research networks, and patient advocacy organizations.

• Provide expertise to Global Safety, Medical Affairs, and Business Development as assigned.

• Enhance knowledge in sepsis, critical care, and immune dysregulation.

• Cultivate relationships with cross-functional teams, local affiliates, and collaborative partners.

• Operate in accordance with scientific, ethical, regulatory, and internal standards.

⛳️ Requirements

• Medical degree (MD) with relevant specialization, or an advanced scientific degree (PhD / PharmD) with equivalent clinical development experience.

• Proven track record in drug development programs.

• Comprehensive understanding of translating early-stage programs into clinical practice and advancing them through the clinical development continuum.

• Familiarity with ICH-GCP and applicable clinical trial regulations.

• Knowledge of sponsor responsibilities related to protocol design, medical monitoring, and study reporting.

• Excellent written and verbal communication skills.

• Strong organizational and project management capabilities.

• Ability to prioritize multiple concurrent studies.

• Capacity to lead and influence cross-functional teams without direct line authority.

• Solid quantitative skills, including the ability to analyze statistical analysis plans, interim outputs, and data trends.

• Professional proficiency in both written and spoken English.

• Strong team player with high personal and scientific integrity.

• Comfortable working in a fast-paced environment with shifting priorities and time-sensitive decisions.

• Intellectual honesty in interpreting uncertain or incomplete data.

• Resilience and sound judgment when handling data from critically ill patients.

• Desired: clinical or research experience in intensive care medicine, anaesthesiology, infectious diseases, internal medicine, or emergency medicine.

• Desired: experience in acute or critical care interventional trials, mortality-based endpoints, adaptive or platform designs, and emergency consent frameworks.

• Desired: understanding of sepsis immunology and pathophysiology, including immune dysregulation and biomarker-guided patient selection.

• Desired: expertise in pharmacokinetics and pharmacodynamics in critically ill patients.

• Additional language skills relevant to key clinical trial regions are preferred.

🏝️ Benefits

• Options for remote work.

• Office-based or hybrid working arrangements.

• Opportunities for international travel for investigator meetings, advisory boards, site visits, congresses, and interactions with Health Authorities.