Senior Toxicologist, Non-Clinical Pharmacology Scientist

🔥 2 hours ago

🇸🇪 Sweden – Remote

⏰ Full Time

🟠 Senior

✨ Clinical Scientist

👻 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

• Define appropriate Toxicology and Non-Clinical Pharmacology strategies for assigned projects • Provide overall accountability for Toxicology and Non-Clinical Pharmacology strategies and activities • 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 drug-product impurities and manufacturing-site questions • 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

🎯 Requirements

• PhD, DVM or equivalent in a relevant discipline • Minimum five years of 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 • Excellent communication and presentation skills • Energetic, driven, and able to take initiative • Results- and delivery-focused, with a structured way of working • Strong problem-solving ability and analytical mindset • Ability to work independently and in teams • Ability to demonstrate Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership

🏖️ Benefits

• Competitive benefits package supporting employee health and happiness • Comprehensive and industry-competitive total rewards package • Inclusive workplace culture where employees feel valued and empowered • Opportunities to contribute to innovative therapies for rare diseases • Global company environment with international collaboration