Clinical Scientist, Sepsis

Key Responsibilities and Scope of the Job

Responsibilities are listed in order of priority and include but are not limited to the following:

1. Clinical development strategy and study design

• Provide clinical scientific and strategic input to clinical development plans for the assigned sepsis programme(s) adhering to the highest scientific and ethical standards.
• Contribute to the definition of the target population including immune phenotype / endotype and biomarker-based enrichment strategies and to the selection of clinically meaningful primary and secondary endpoints (for example all-cause mortality at a pre-specified day organ support-free days change in organ dysfunction scores).
• Contribute to the evaluation of design options appropriate to acute critical care research including adaptive platform and Bayesian approaches and document the assumptions effect-size estimates and event-rate expectations on which sample size and feasibility depend.
• Collaborate with the Medical Development Lead (MDL) and Medical Program Lead (MPL) on the overall scientific and medical development strategy.

2. Study execution medical oversight and reporting

• Act as the clinical scientific lead for assigned Sobi-sponsored studies. Where the incumbent holds a medical degree and the responsibility is formally delegated act as Medical Director / Medical Monitor for those studies.
• Take responsibility for planning designing conducting (including medical monitoring) and reporting Sobi-sponsored studies in close collaboration with Clinical Operations study teams Regulatory Affairs Patient Safety and other cross-functional HQ functions.
• Author clinical study protocols and clinical study reports and contribute to statistical analysis plans informed consent templates and other core study documents.
• Support operational feasibility specific to intensive care and emergency department settings including short screening and treatment windows out-of-hours randomisation deferred or emergency consent processes where legally permitted and biomarker and central laboratory logistics.
• Perform ongoing medical review of emerging safety and efficacy data in a population with high background morbidity and mortality supporting attribution of adverse events safety review committee and DSMB interactions and pre-specified interim analyses.
• Participate in investigator meetings site training and other study-related activities.

3. Regulatory and submission activities

• Provide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products and projects as requested and appropriate.
• Contribute high-quality scientific and medical input to the clinical components of regulatory submissions and to responses to Health Authority questions including scientific advice IND applications and marketing authorisation applications.
• Maintain current awareness of applicable regulatory guidance and precedent relevant to acute critical care and sepsis trials and of expedited pathway options where relevant.

4. External scientific engagement

• Interact and consult with key opinion leaders in critical care infectious diseases and immunology and support or lead advisory boards to inform development plans for new products and indications.
• Represent Sobi at international conferences and scientific symposia and support engagement with sepsis-focused scientific societies research networks and patient advocacy organisations.

5. Cross-functional and business support

• Where assigned provide scientific and medical expertise to other Sobi functions including Global Safety Medical Affairs (advisory boards scientific communications and publications) and Business Development (due diligence of external compounds M&A evaluation).

6. Expected ways of working

• Build and maintain a substantive and current knowledge base in sepsis critical care and immune dysregulation.
• Develop productive working relationships within cross-functional HQ teams with local affiliates and with collaborative partners.
• Role-model the highest scientific and ethical standards and work in accordance with all applicable rules regulations and internal procedures governing scientific and medical activities.

Qualifications :

Education learning experience and work experience

Required

• Medical degree (MD) with relevant specialisation or an advanced scientific degree (PhD / PharmD) with equivalent clinical development experience. Note: medical monitoring and Medical Director accountabilities require a medical degree see the annex.
• Documented record of accomplishment in drug development programmes demonstrating an in-depth understanding of translating early-stage programmes into the clinic and progressing them across the clinical development chain.
• Working knowledge of ICH-GCP applicable clinical trial regulations and the sponsor obligations attached to protocol design medical monitoring and study reporting.

Desired

• Clinical or research experience in intensive care medicine anaesthesiology infectious diseases internal medicine or emergency medicine.
• Experience in acute or critical care interventional trials including mortality-based endpoints adaptive or platform designs and emergency consent frameworks.
• Understanding of the immunology and pathophysiology of sepsis including immune dysregulation hyperinflammatory and immunosuppressed phenotypes and biomarker-guided patient selection.
• Expertise in pharmacokinetics and pharmacodynamics including altered PK in critically ill patients (for example capillary leak altered volume of distribution renal replacement therapy).
• Ability to bring a medical and scientific perspective and drug development judgement to business development corporate strategy and leadership decision-making.

Skills knowledge and languages

Required

• Strong written and verbal communication skills with demonstrated ability to represent the company credibly to internal and external audiences including international conferences scientific symposia and collaborations.
• Strong organisational and project management skills with the ability to prioritise across concurrent studies and to act as a self-motivated driver of best practice.
• Demonstrated ability to lead and influence cross-functional teams without direct line authority.
• Sound quantitative literacy: able to interrogate statistical analysis plans interim outputs and data trends in dialogue with Biostatistics.
• Professional proficiency in written and spoken English.

Desired

• Ability to demonstrate behaviours in line with Sobis core values: Care Ambition Urgency Ownership and Partnership.
• Additional language skills relevant to key clinical trial regions.

Personal attributes

Required

• 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 in the interpretation of uncertain or incomplete data including willingness to state limitations and revise positions in light of evidence.
• Resilience and sound judgement when working with data from a severely ill patient population.

Additional Information :

• International travel is expected for investigator meetings advisory boards site visits congresses and Health Authority interactions. Indicative volume to be confirmed by the hiring manager.
• Because sepsis studies enrol in intensive care and emergency settings occasional out-of-hours availability for urgent medical or safety queries may be required. Any on-call expectation should be defined locally in line with applicable labour law.
• The role is office-based or hybrid with periodic clinical site presence. Working arrangements follow the applicable local Sobi policy.

Remote Work :

Yes

Employment Type :

Full-time