Scientist Research Laboratory
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 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.
Clinical development strategy and study design
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.
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.
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.
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.
Clinical or research experience in intensive care medicine, anaesthesiology, infectious diseases, internal medicine or emergency medicine.
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.
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.
Additional language skills relevant to key clinical trial regions.
Comfortable operating in a fast-paced environment with shifting priorities and time-critical decisions.
Because sepsis studies enrol in intensive care and emergency settings, occasional out-of-hours availability for urgent medical or safety queries may be required.
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.
Clinical development strategy and study design
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.
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.
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.
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.
Clinical or research experience in intensive care medicine, anaesthesiology, infectious diseases, internal medicine or emergency medicine.
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.
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.
Additional language skills relevant to key clinical trial regions.
Comfortable operating in a fast-paced environment with shifting priorities and time-critical decisions.
Because sepsis studies enrol in intensive care and emergency settings, occasional out-of-hours availability for urgent medical or safety queries may be required.
