Clinical Scientist, Sepsis

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

📋 Description

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

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

• Choose primary and secondary endpoints that are clinically relevant.

• Assess options for adaptive, platform, and Bayesian trial designs.

• Collaborate on the overarching scientific and medical development strategy.

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

• When formally assigned and medically qualified, function as Medical Director/Medical Monitor.

• Plan, design, execute, medically monitor, 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.

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

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

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

• Provide expertise in interactions with regulatory authorities and clinical components of regulatory submissions.

• Assist in responding to Health Authority inquiries, scientific advice, IND applications, and marketing authorization applications.

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

• Represent Sobi at international conferences and scientific symposia.

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

• Offer scientific and medical 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 relevant specialization.

• Proven track record in drug development programs, showcasing a deep understanding of transitioning early-stage programs into clinical practice and advancing them through the clinical development chain.

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

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

• Exceptional written and verbal communication skills.

• Strong organizational and project management capabilities.

• Ability to prioritize multiple concurrent studies and promote best practices.

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

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

• Professional proficiency in both written and spoken English.

• Excellent team player with high levels of 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 dealing with data from a critically ill patient population.

🏝️ Benefits

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

• Office-based or hybrid working arrangements as per applicable local Sobi policy.

• Regular clinical site presence.

• Potential for occasional out-of-hours availability arrangements defined locally in accordance with applicable labor laws.