Clinical Scientist, Sepsis

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

📋 Description

• Provide clinical, scientific, and strategic contributions to clinical development plans for designated sepsis programs.

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

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

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

• When formally delegated and possessing a medical degree, function as Medical Director / Medical Monitor.

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

• Draft clinical study protocols and clinical study reports.

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

• Assist in operational feasibility assessments in intensive care and emergency department environments.

• Conduct ongoing medical reviews of emerging safety and efficacy data.

• Aid in adverse-event attribution, safety review committee, and DSMB interactions, as well as interim analyses.

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

• Offer clinical development expertise during regulatory authority interactions.

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

• Maintain familiarity with regulatory guidance and precedents relevant to acute critical care and sepsis trials.

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

• Represent Sobi at international conferences and scientific symposia.

• Foster engagement with scientific societies, research networks, and patient advocacy organizations.

• Provide expertise to Global Safety, Medical Affairs, and Business Development when necessary.

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

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

• Operate in accordance with applicable rules, regulations, and internal procedures.

⛳️ Requirements

• Medical degree (MD) with relevant specialization.

• Documented history of success in drug development programs, showcasing a comprehensive understanding of transitioning early-stage programs into clinical settings and advancing them through the clinical development process.

• Proficient understanding of ICH-GCP and applicable clinical trial regulations.

• Familiarity with sponsor obligations linked to protocol design, medical monitoring, and study reporting.

• Excellent written and verbal communication abilities.

• Strong organizational and project management skills.

• Capability to lead and influence cross-functional teams without direct reporting authority.

• Solid quantitative literacy, 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 a commitment to personal and scientific integrity.

• Comfortable working in a fast-paced environment with changing priorities and urgent decision-making.

• Intellectual honesty in interpreting uncertain or incomplete data.

• Resilience and sound judgment when working with data from critically ill patient populations.

• Willingness to occasionally be available outside regular hours for urgent medical or safety inquiries.

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

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

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

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

• Desired: Additional language skills pertinent to key clinical trial regions.

🏝️ Benefits

• Employees have the option to work remotely.

• Flexible working arrangements, including office-based or hybrid options.

• Occasional clinical site presence required.

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