Clinical Scientist, Sepsis

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Sobi - Swedish Orphan Biovitrum AB (publ)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1991

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Sobi - Swedish Orphan Biovitrum AB (publ) is a global leader in providing innovative treatments for people with rare diseases. Specializing in therapeutic areas such as haematology and immunology, Sobi is committed to improving patient access to medicines for rare and debilitating conditions. With a strong R&D pipeline, the company is actively pursuing new therapies and collaborating globally to transform patient care in areas such as haemophilia and immune thrombocytopenia. Sobi also engages in extensive sustainability and humanitarian aid programs, demonstrating a firm commitment to patient-centric care and societal contributions.

📋 Description

• Provide clinical, scientific and strategic input to clinical development plans for assigned sepsis programmes • Define target populations, immune phenotypes/endotypes, biomarker-based enrichment strategies and clinically meaningful endpoints • Evaluate adaptive, platform and Bayesian trial design options and document assumptions supporting sample size and feasibility • Collaborate on overall scientific and medical development strategy • Act as clinical scientific lead for assigned Sobi-sponsored studies • Where formally delegated and medically qualified, act as Medical Director / Medical Monitor • Plan, design, conduct, medically monitor and report Sobi-sponsored studies • Author clinical study protocols and clinical study reports • Contribute to statistical analysis plans, informed consent templates and other core study documents • Support operational feasibility in intensive care and emergency department settings • Review emerging safety and efficacy data and support adverse-event attribution, safety review committee and DSMB interactions, and interim analyses • Participate in investigator meetings, site training and other study activities • Provide clinical development expertise in regulatory-authority interactions • Contribute scientific and medical input to regulatory submissions and Health Authority responses • Maintain awareness of regulatory guidance, precedent and expedited pathways relevant to sepsis trials • Interact with key opinion leaders and support or lead advisory boards • Represent Sobi at international conferences and scientific symposia • Engage with sepsis-focused scientific societies, research networks and patient advocacy organisations • Provide expertise to Global Safety, Medical Affairs and Business Development when assigned • Build current knowledge in sepsis, critical care and immune dysregulation • Develop relationships with cross-functional teams, local affiliates and collaborative partners • Work according to scientific, ethical, regulatory and internal standards

🎯 Requirements

• Medical degree (MD) with relevant specialisation, or an advanced scientific degree (PhD / PharmD) with equivalent clinical development experience • Documented record of accomplishment in drug development programmes • In-depth understanding of translating early-stage programmes into the clinic and progressing them across the clinical development chain • Working knowledge of ICH-GCP and applicable clinical trial regulations • Understanding of sponsor obligations attached to protocol design, medical monitoring and study reporting • Strong written and verbal communication skills • Strong organisational and project management skills • Ability to prioritise across concurrent studies • Ability to lead and influence cross-functional teams without direct line authority • Sound quantitative literacy, including ability to interrogate statistical analysis plans, interim outputs and data trends • Professional proficiency in written and spoken English • 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 interpreting uncertain or incomplete data • Resilience and sound judgement when working with data from a severely ill patient population • Desired: clinical or research experience in intensive care medicine, anaesthesiology, infectious diseases, internal medicine or emergency medicine • Desired: experience in acute or critical care interventional trials, mortality-based endpoints, adaptive or platform designs and emergency consent frameworks • Desired: understanding of sepsis immunology and pathophysiology, including immune dysregulation and biomarker-guided patient selection • Desired: expertise in pharmacokinetics and pharmacodynamics in critically ill patients • Additional language skills relevant to key clinical trial regions are desired

🏖️ Benefits

• Remote work options • Office-based or hybrid working arrangements • International travel opportunities for investigator meetings, advisory boards, site visits, congresses and Health Authority interactions