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.

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, …