Clinical Scientist, Sepsis

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

📋 Description

• Provide clinical, scientific, and strategic insights for clinical development plans related to assigned sepsis programs.

• Define target demographics, immune phenotypes/endotypes, biomarker-based enrichment techniques, and clinically significant endpoints.

• Assess adaptive, platform, and Bayesian trial design alternatives while documenting 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.

• When formally delegated and medically qualified, take on the role of Medical Director/Medical Monitor.

• Plan, design, conduct, medically oversee, and report on sponsored clinical studies.

• Write clinical study protocols and clinical study reports.

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

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

• Review emerging safety and efficacy data and aid in adverse event attribution, safety review committee, and DSMB interactions.

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

• Facilitate regulatory interactions, clinical submissions, and responses to inquiries from Health Authorities.

• Stay informed about regulatory guidance, precedents, and expedited pathway options.

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

• Represent Sobi at international conferences and scientific symposia.

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

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

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

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

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

⛳️ Requirements

• Medical degree (MD) with a relevant specialization.

• Proven track record in drug development programs.

• Extensive knowledge of transitioning early-stage programs into clinical settings and advancing them throughout the clinical development process.

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

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

• Excellent written and verbal communication skills.

• Strong organizational and project management abilities.

• Capacity to prioritize across multiple simultaneous studies.

• Proven capability 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 command of written and spoken English.

• Team-oriented individual with high personal and scientific integrity.

• Ability to thrive 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 a critically ill patient population.

🏝️ Benefits

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

• Office-based or hybrid work arrangements in accordance with applicable local Sobi policies.

• Periodic presence at clinical sites.

• Potential local on-call arrangements compliant with applicable labor laws.