Clinical Scientist, Sepsis

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

📋 Description

• Design, implement, and report on Sobi-sponsored clinical studies within the sepsis therapeutic area.

• Offer clinical, scientific, and strategic contributions to clinical development plans.

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

• Assess adaptive, platform, and Bayesian trial designs, documenting the underlying assumptions.

• Serve as the clinical scientific lead for designated studies.

• When formally designated and medically qualified, fulfill the role of Medical Director / Medical Monitor.

• Plan, execute, medically oversee, and report on sponsored studies in collaboration with cross-functional teams.

• Draft clinical study protocols and clinical study reports.

• Contribute to statistical analysis plans, informed consent templates, and core study documentation.

• Aid in assessing operational feasibility within intensive care and emergency department environments.

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

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

• Facilitate interactions with regulatory authorities, clinical submissions, and responses to Health Authority inquiries.

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

• Represent Sobi at international conferences and scientific symposia.

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

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

⛳️ Requirements

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

• Proven track record in drug development programs.

• Comprehensive understanding of transitioning early-stage programs into clinical settings and navigating 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 abilities.

• Strong organizational and project management capabilities.

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

• Proficient quantitative literacy, including the capacity to analyze statistical analysis plans, interim outputs, and data trends.

• Professional proficiency in both written and spoken English.

• A solid team player with high personal and scientific integrity.

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

• Intellectual honesty when interpreting uncertain or incomplete data.

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

• Occasional clinical site presence and out-of-hours availability may be necessary.

🏝️ Benefits

• Employees have the option to work remotely.

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

• Hybrid work arrangements in accordance with applicable local Sobi policies.