Clinical Scientist, Sepsis — Sobi
NouveauCHF 72 500 - 110 500
Sobi · Basel (BS)
- Lieu
- Basel
- Contrat
- full-time
- Publié
- il y a 5 jours
SalaireCHF 72 500 - 110 500
Vue d’ensemble du poste
Key Responsibilities and Scope of the Job Responsibilities are listed in order of priority and include, but are not limited to, the following:
- 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.
- 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.
- Key Responsibilities and Scope of the Job
- are listed in order of priority and include, but are not limited to, the following:
Responsabilités principales
- Key Responsibilities and Scope of the Job
- are listed in order of priority and include, but are not limited to, the following:
- 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.
- 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.
Processus de candidature
- 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. 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. 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). 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.
Détails supplémentaires
- Responsibilities are listed in order of priority and include, but are not limited to, the following:
- Participate in investigator meetings, site training and other study-related activities. Regulatory and submission activities
- Maintain current awareness of applicable regulatory guidance and precedent relevant to acute critical care and sepsis trials, and of expedited pathway options where relevant. External scientific engagement
- Represent Sobi at international conferences and scientific symposia, and support engagement with sepsis-focused scientific societies, research networks and patient advocacy organisations. 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). Expected ways of working
- Education, learning experience and work experience
- Working knowledge of ICH-GCP, applicable clinical trial regulations and the sponsor obligations attached to protocol design, medical monitoring and study reporting.
- 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
- Professional proficiency in written and spoken English.
- Additional language skills relevant to key clinical trial regions. Personal attributes
Notes et contenu original
- Participate in investigator meetings, site training and other study-related activities.
- Regulatory and submission activities
- Maintain current awareness of applicable regulatory guidance and precedent relevant to acute critical care and sepsis trials, and of expedited pathway options where relevant.
- External scientific engagement
- Represent Sobi at international conferences and scientific symposia, and support engagement with sepsis-focused scientific societies, research networks and patient advocacy organisations.
- 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).
- Expected ways of working
- 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
Questions sur cette offre
Quel salaire propose Sobi pour ce poste ?
Sobi indique CHF 72 500 - 110 500 bruts par an pour ce poste à Basel. Il s'agit du salaire publié dans l'annonce d'origine (ou, si l'employeur ne précise pas de montant, d'une estimation réaliste pour le rôle et le secteur) — le calculateur de ce site le convertit en net réel une fois l'impôt frontalier et les cotisations sociales appliqués.
Est-ce un poste à temps plein, et quel type de contrat propose Sobi ?
Cette offre est un poste en temps plein. Le type de contrat affiché ici provient directement de l'annonce originale de l'employeur ; confirmez toujours les horaires exacts, le préavis et la durée d'essai avec Sobi pendant le processus de candidature, ces détails pouvant varier même au sein de la même catégorie de contrat.
Ai-je besoin d'un permis de frontalier pour un poste dans le canton de Bâle ?
Les résidents UE/AELE domiciliés dans la zone frontalière du pays voisin du canton de Bâle peuvent demander un permis G ; l'employeur suisse le dépose auprès de l'office cantonal des migrations après signature du contrat. Les règles de zone frontalière et les délais varient selon le pays voisin et le canton — confirmez les détails auprès de l'office des migrations du canton de Bâle ou avec les RH pendant la candidature.
Comment postuler à ce poste chez Sobi ?
Utilisez le bouton « Postuler maintenant » sur cette page — il renvoie directement à l'annonce originale de Sobi sur jobs.smartrecruiters.com, votre candidature arrive donc directement dans le système de suivi des candidatures de l'employeur. Frontaliere Ticino ne collecte ni ne transmet lui-même les candidatures.
