Clinical Scientist, Sepsis

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

📋 Description

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

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

• Assess adaptive, platform, and Bayesian trial designs while documenting the assumptions that support sample size and feasibility.

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

• Plan, design, execute, medically monitor, and report on sponsored clinical studies.

• Draft clinical study protocols and clinical study reports.

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

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

• Review emerging safety and efficacy data, assisting with adverse-event attribution, safety review committee, and DSMB interactions.

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

• Aid in regulatory authority interactions and contribute to the clinical sections of regulatory submissions and responses.

• Engage 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.

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

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

• Adhere to applicable rules, regulations, and internal procedures.

⛳️ 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, showcasing a deep understanding of translating early-stage programs into clinical practice and advancing them through the clinical development continuum.

• Familiarity with ICH-GCP, relevant clinical trial regulations, and sponsor obligations related to protocol design, medical monitoring, and study reporting.

• Excellent written and verbal communication skills.

• Strong organizational and project management abilities.

• Capacity to lead and influence cross-functional teams without direct line 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 high personal and scientific integrity.

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

• Intellectual honesty in interpreting uncertain or incomplete data.

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

• Medical monitoring and Medical Director responsibilities require a medical degree.

• Occasional out-of-hours availability may be necessary for urgent medical or safety inquiries.

🏝️ Benefits

• Employees have the option to work remotely.

• Office-based or hybrid working arrangements according to applicable local Sobi policy.

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