Clinical Scientist, Sepsis

ppSobi 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 . /p pThe 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. /p pThe 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. /p pThe 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. /p h3Job Description /h3 pbKey Responsibilities and Scope of the Job /b /p pResponsibilities are listed in order of priority and include, but are not limited to, the following: /p p1. Clinical development strategy and study design /p ul liProvide clinical, scientific and strategic input to clinical development plans for the assigned sepsis programme(s), adhering to the highest scientific and ethical standards. /li liContribute 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). /li liContribute 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. /li liCollaborate with the Medical Development Lead (MDL) and Medical Program Lead (MPL) on the overall scientific and medical development strategy. /li /ul p2. Study execution, medical oversight and reporting /p ul liAct 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. /li liTake 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. /li liAuthor clinical study protocols and clinical study reports, and contribute to statistical analysis plans, informed consent templates and other core study documents. /li liSupport 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. /li liPerform 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. /li liParticipate in investigator meetings, site training and other study‑related activities. /li /ul p3. Regulatory and submission activities /p ul liProvide strategic and operational clinical development expertise in interactions with regulatory authorities for assigned products and projects, as requested and appropriate. /li liContribute 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. /li liMaintain current awareness of applicable regulatory guidance and precedent relevant to acute critical care and sepsis trials, and of expedited pathway options where relevant. /li liInteract 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. /li liRepresent Sobi at international conferences and scientific symposia, and support engagement with sepsis‑focused scientific societies, research networks and patient advocacy organisations. /li /ul p5. Cross‑functional and business support /p ul liWhere 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, MA evaluation). /li /ul p6. Expected ways of working /p ul liBuild and maintain a substantive and current knowledge base in sepsis, critical care and immune dysregulation. /li liDevelop productive working relationships within cross‑functional HQ teams, with local affiliates and with collaborative partners. /li liRole‑model the highest scientific and ethical standards and work in accordance with all applicable rules, regulations and internal procedures governing scientific and medical activities. /li /ul h3Qualifications /h3 pbEducation, learning experience and work experience /b /p pRequired /p ul liMedical 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. /li liDocumented 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. /li liWorking knowledge of ICH‑GCP, applicable clinical trial regulations and the sponsor obligations attached to protocol design, medical monitoring and study reporting. /li liClinical or research experience in intensive care medicine, anaesthesiology, infectious diseases, internal medicine or emergency medicine. /li liExperience in acute or critical care interventional trials, including mortality‑based endpoints, adaptive or platform designs and emergency consent frameworks. /li liUnderstanding of the immunology and pathophysiology of sepsis, including immune dysregulation, hyperinflammatory and immunosuppressed phenotypes, and biomarker‑guided patient selection. /li liExpertise in pharmacokinetics and pharmacodynamics, including altered PK in critically ill patients (for example capillary leak, altered volume of distribution, renal replacement therapy). /li liAbility to bring a medical and scientific perspective and drug development judgement to business development, corporate strategy and leadership decision‑making. /li /ul pbSkills, knowledge and languages /b /p pRequired /p ul liStrong 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. /li liStrong organisational and project management skills, with the ability to prioritise across concurrent studies and to act as a self‑motivated driver of best practice. /li liDemonstrated ability to lead and influence cross‑functional teams without direct line authority. /li liSound quantitative literacy: able to interrogate statistical analysis plans, interim outputs and data trends in dialogue with Biostatistics. /li liProfessional proficiency in written and spoken English. /li liAbility to demonstrate behaviours in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. /li liAdditional language skills relevant to key clinical trial regions. /li /ul pbPersonal attributes /b /p pRequired /p ul liStrong team player with high personal and scientific integrity. /li liComfortable operating in a fast‑paced environment with shifting priorities and time‑critical decisions. /li liIntellectual honesty in the interpretation of uncertain or incomplete data, including willingness to state limitations and revise positions in light of evidence. /li liResilience and sound judgement when working with data from a severely ill patient population. /li /ul h3Additional Information /h3 ul liInternational travel is expected for investigator meetings, advisory boards, site visits, congresses and Health Authority interactions. Indicative volume to be confirmed by the hiring manager. /li liBecause 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. /li liThe role is office‑based or hybrid, with periodic clinical site presence. Working arrangements follow the applicable local Sobi policy. /li /ul pBy clicking the link above or any third‑party link within this posting, you are leaving this site and going to a third‑party website where the third‑party website's terms and privacy policy apply /p /p #J-18808-Ljbffr