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 • Basel • 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 interactions. Possesses strong leadership and project management skills to effectively engage cross-functional teams and manage concurrent studies.

Highest-signal resume keywords

Medical Degree (MD)Clinical Study Protocol DevelopmentICH-GCP KnowledgeDrug Development ExperienceStatistical Analysis Plan Evaluation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Development PlanningBiomarker-Based Enrichment StrategiesAdaptive Trial DesignSample Size Feasibility AssessmentClinical Study Reporting

Soft Skills

Strong Written CommunicationStrong Verbal CommunicationOrganizational SkillsProject Management SkillsTeam Leadership

Industry Keywords

SepsisCritical CareImmune DysregulationRegulatory GuidanceAdverse Event Attribution

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, biomarker-based enrichment strategies and clinically meaningful endpoints
Evaluate adaptive, platform and Bayesian trial design options and document assumptions underpinning sample size and feasibility
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 sponsored clinical studies
Author clinical study protocols and clinical study reports
Contribute to statistical analysis plans, informed consent templates and other core study documents
Support 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
Participate in investigator meetings, site training and other study activities
Support regulatory interactions, clinical submissions and responses to Health Authority questions
Maintain awareness of regulatory guidance, precedent and expedited pathway options
Engage 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 expertise to Global Safety, Medical Affairs and Business Development
Build 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
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
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 under applicable local Sobi policy
Periodic clinical site presence
Potential local on-call arrangements aligned with applicable labour law