
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.
🔥 8 hours ago
Where this job comes from
Posted on Sobi - Swedish Orphan Biovitrum AB (publ)'s careers page, not through a job board
First seen by Remote Rocketship 8 hours ago
Still open on Sobi - Swedish Orphan Biovitrum AB (publ)'s site. Checked 1 hour ago.
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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.
• Define Toxicology and Non-Clinical Pharmacology strategies for assigned projects • Hold overall accountability for Toxicology and Non-Clinical Pharmacology strategies and activities in appointed projects • Provide expert Toxicology and Non-Clinical Pharmacology knowledge to cross-functional teams • Own Toxicology and Non-Clinical Pharmacology modules and sections in regulatory documents, including IB, IND and IMPD summaries, RMP, and briefing documentation • Manage interactions with regulatory authorities regarding non-clinical pharmacology and Toxicology • Manage preclinical safety studies at Contract Research Organizations, including design, monitoring, discussion, and reporting of safety findings • Ensure translational aspects and safety alerts from literature or Toxicology studies are integrated and communicated within the Benefit/Risk team • Perform Toxicology assessments for impurities in drug products and support questions from manufacturing sites • Participate in internal and external scientific communications, including oral presentations, posters, and publications • Support Clinical and Core Asset Teams for products under development or geographic expansion of established products
• PhD, DVM or equivalent in a relevant discipline • Minimum of five years’ experience as a project toxicologist • Demonstrated ability to manage multiple projects across various development stages • Experience with biologics and small molecules required • Experience with oligonucleotides, gene therapy, or combination drugs is a strong plus • Board certification such as DABT/ERT is a plus • Extensive regulatory toxicology experience required • Solid understanding of the drug-development process, including late-stage development and life-cycle management for established compounds • Experience in immunotoxicology is a plus • Fluency in written and spoken English • Strong communication and presentation skills • Ability to take initiative with a can-do attitude • Results- and delivery-focused, structured working style • Strong problem-solving ability and analytical mindset • Ability to work independently and in teams • Alignment with Sobi’s core values: Care, Ambition, Urgency, Ownership, and Partnership
• Comprehensive and industry-competitive total rewards package • Competitive benefits package supporting the health and happiness of staff • Inclusive workplace culture • Opportunities to contribute to innovative therapies for rare diseases • Global company environment • Internal and external scientific communication opportunities, including presentations, posters, and publications
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