临床科学家, 败血症

Sobi is an international biopharmaceutical company, dedicated to providing access to innovative treatments that transform life for people with rare diseases in the areas of haematology, immunology and specialty care. With our head office in Stockholm, Sweden, Sobi also has premises in Basel, Switzerland. You can find more information about Sobi at www.sobi.com.
The Clinical Scientist, Sepsis is accountable for the design, execution and reporting of Sobi-sponsored clinical studies within the sepsis therapeutic area, and acts as a scientific and medical subject-matter expert for the assigned development programme across operational, regulatory and drug safety matters.
The role operates in a therapeutic area characterised by high unmet need, high background mortality, heterogeneous patient populations and no established precedent of approved disease-modifying therapies. The position therefore carries an explicit expectation of methodological rigour: precise definition of target populations and endpoints, defensible assumptions underpinning trial design, and transparent handling of uncertainty in interpreting emerging data.
The position reports to the TA Head, Sepsis and works within the Medical Development Team and Clinical Study Teams, in close partnership with Clinical Operations, Biostatistics, Regulatory Affairs, Patient Safety, Translational Medicine and external investigators.

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.
· 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 Sobi's 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.

• 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.