Senior Toxicologist, Non-Clinical Pharmacology Scientist

This is a fully remote position, open to applicants in Sweden.

📋 Description

• Establish suitable Toxicology and Non-Clinical Pharmacology strategies for designated projects.

• Assume overall responsibility for Toxicology and Non-Clinical Pharmacology strategies and initiatives.

• Provide in-depth Toxicology and Non-Clinical Pharmacology expertise to cross-functional teams.

• Manage Toxicology and Non-Clinical Pharmacology modules and sections within regulatory documents, including Investigator's Brochures (IB), Investigational New Drug applications (IND), and Investigational Medicinal Product Dossiers (IMPD), Risk Management Plans (RMP), and briefing documents.

• Oversee interactions with regulatory bodies concerning non-clinical pharmacology and Toxicology.

• Coordinate preclinical safety studies at Contract Research Organizations, including the design, monitoring, discussion, and reporting of safety findings.

• Ensure that translational elements and safety alerts from literature or Toxicology studies are incorporated and communicated within the Benefit/Risk team.

• Conduct Toxicology evaluations for drug product impurities and inquiries related to manufacturing sites.

• Engage in internal and external scientific communications, such as oral presentations, posters, and publications.

• Assist Clinical and Core Asset Teams for products in development or for the geographic expansion of established products.

⛳️ Requirements

• PhD, DVM, or equivalent qualification in a relevant field.

• At least five years of experience as a project toxicologist.

• Proven capability to manage multiple projects across various stages of development.

• Required experience with biologics and small molecules.

• Experience with oligonucleotides, gene therapy, or combination drugs is highly advantageous.

• Board certification, such as DABT/ERT, is a plus.

• Extensive experience in regulatory toxicology is essential.

• Strong understanding of the drug development process, including late-stage development and life-cycle management for established compounds.

• Experience in immunotoxicology is an advantage.

• Proficiency in both written and spoken English.

• Exceptional communication and presentation skills.

• Energetic, motivated, and capable of taking initiative.

• Results-oriented and delivery-focused, with a systematic approach to work.

• Strong problem-solving skills and an analytical mindset.

• Ability to work independently as well as collaboratively in teams.

• Ability to embody Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership.

🏝️ Benefits

• Competitive benefits package that promotes employee health and satisfaction.

• Comprehensive and industry-leading total rewards program.

• Inclusive workplace culture where employees feel appreciated and empowered.

• Opportunities to contribute to groundbreaking therapies for rare diseases.

• Global company environment fostering international collaboration.