Clinical Scientist, Sepsis

Sobi - Swedish Orphan Biovitrum AB (publ)

. Provide clinical, scientific and strategic input to clinical development plans for assigned sepsis programmes .

Posted 9/15/2026full-timeRemote • Munich • Alabama • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development for sepsis programs, including protocol design, medical monitoring, and regulatory submissions. Possesses strong leadership and project management skills to drive cross-functional collaboration and ensure compliance with clinical trial regulations.

Highest-signal resume keywords

Medical Degree (MD)Clinical Development ExpertiseICH-GCP KnowledgeProject Management SkillsStatistical Analysis Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Protocol AuthoringBiomarker-Based Enrichment StrategiesAdaptive Trial DesignMedical MonitoringStatistical Analysis PlansEndpoint SelectionRegulatory Submission ExpertiseSafety Review Committee InteractionData Trend AnalysisClinical Reporting

Soft Skills

Strong Communication SkillsOrganizational SkillsTeam LeadershipResilienceIntellectual Honesty

Industry Keywords

SepsisCritical CareImmune DysregulationDrug DevelopmentHealth Authority InteractionsAdvisory BoardsPatient AdvocacyClinical Trial RegulationsEmergency Department SettingsCross-Functional Collaboration

About the role

Key responsibilities & impact

Provide clinical, scientific and strategic input to clinical development plans for assigned sepsis programmes
Define target populations, immune phenotypes/endotypes and biomarker-based enrichment strategies
Select clinically meaningful primary and secondary endpoints
Evaluate adaptive, platform and Bayesian trial design options
Collaborate on overall scientific and medical development strategy
Act as clinical scientific lead for assigned Sobi-sponsored studies
Where formally delegated and medically qualified, act as Medical Director/Medical Monitor
Plan, design, conduct, medically monitor and report Sobi-sponsored studies
Author clinical study protocols and clinical study reports
Contribute to statistical analysis plans, informed consent templates and other core study documents
Support operational feasibility in intensive care and emergency department settings
Review emerging safety and efficacy data and support adverse-event attribution, safety review committee and DSMB interactions, and interim analyses
Participate in investigator meetings, site training and study-related activities
Provide expertise in regulatory-authority interactions and clinical components of regulatory submissions
Contribute to responses to Health Authority questions, scientific advice, IND applications and marketing authorisation applications
Engage with key opinion leaders and support or lead advisory boards
Represent Sobi at international conferences and scientific symposia
Support engagement with scientific societies, research networks and patient advocacy organisations
Provide scientific and medical expertise to Global Safety, Medical Affairs and Business Development
Build current knowledge in sepsis, critical care and immune dysregulation
Develop relationships with cross-functional teams, local affiliates and collaborative partners
Work according to applicable rules, regulations and internal procedures

Requirements

What you’ll need

Medical degree (MD) with relevant specialisation
Documented record of accomplishment in drug development programmes, demonstrating in-depth understanding of translating early-stage programmes into the clinic and progressing them across the clinical development chain
Working knowledge of ICH-GCP and applicable clinical trial regulations
Understanding of sponsor obligations attached to protocol design, medical monitoring and study reporting
Strong written and verbal communication skills
Strong organisational and project management skills
Ability to prioritise across concurrent studies and drive best practice
Demonstrated ability to lead and influence cross-functional teams without direct line authority
Sound quantitative literacy, including ability to interrogate statistical analysis plans, interim outputs and data trends
Professional proficiency in written and spoken English
Strong team player with high personal and scientific integrity
Comfortable operating in a fast-paced environment with shifting priorities and time-critical decisions
Intellectual honesty when interpreting uncertain or incomplete data
Resilience and sound judgement when working with data from a severely ill patient population

Benefits

Comp & perks

International travel for investigator meetings, advisory boards, site visits, congresses and Health Authority interactions
Office-based or hybrid working arrangements according to applicable local Sobi policy
Periodic clinical site presence
Potential occasional out-of-hours availability arrangements defined locally in line with applicable labour law