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 designs and document assumptions underpinning sample size and feasibility • Act as clinical scientific lead for assigned Sobi-sponsored studies • Plan, design, conduct, medically monitor and report sponsored clinical 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 • Participate in investigator meetings, site training and study-related activities • Support regulatory authority interactions and contribute to clinical sections of regulatory submissions and responses • Engage with key opinion leaders and support or lead advisory boards • Represent Sobi at international conferences and scientific symposia • Support engagement with scientific societies, research networks and patient advocacy organisations • Provide expertise to Global Safety, Medical Affairs and Business Development • Build current knowledge in sepsis, critical care and immune dysregulation • Develop productive relationships with cross-functional HQ teams, local affiliates and collaborative partners • Work according to applicable rules, regulations and internal procedures

🎯 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, demonstrating 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 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 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 • Medical monitoring and Medical Director accountabilities require a medical degree • Occasional out-of-hours availability may be required for urgent medical or safety queries

🏖️ Benefits

• Employees can work remotely • Office-based or hybrid working arrangements under applicable local Sobi policy • International travel opportunities for investigator meetings, advisory boards, site visits, congresses and Health Authority interactions