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Senior Toxicologist, Non-Clinical Pharmacology Scientist
Contract type
Ongoing
Work mode
Remote · Europe
Experience
Senior · 5+ years
Job description
Senior Toxicologist / Non-Clinical Pharmacology Scientist in Sobi's Preclinical Development and Translational Medicine (PDTM) Department, responsible for Toxicology and Non-Clinical Pharmacology activities in projects supporting Clinical and Core Asset Teams.
At a glance
- Work mode
- Remote · Europe
- Languages
- English – fluent
What you'll do
- Define appropriate strategies for Toxicology and Non-Clinical Pharmacology in assigned projects
- Overall accountability for Toxicology and Non-Clinical Pharmacology strategies and activities in appointed projects
- Provide expert knowledge in Toxicology and Non-Clinical Pharmacology to the cross-functional teams
- Responsible for Toxicology and Non-Clinical pharmacology modules and sections in regulatory documents (including IB, summaries for IND and IMPD, RMP, briefing documentation)
- Responsible for interactions with regulatory authorities for all questions related to non-clinical pharmacology and Toxicology for assigned projects
- Manage preclinical safety studies in Contract Research Organizations: design, monitor, discuss and report the safety findings
- Ensure translational aspects are taken into account and optimally used and integrated as well as any safety alerts emerging from literature or Toxicology studies are communicated and discussed within the Benefit/risk team
- Perform all required Toxicology assessments for impurities in the drug products or to support questions from manufacturing sites
- Participate in internal and external scientific communications (oral presentations, posters, publication)
What we're looking for
- PhD, DVM or equivalent in relevant discipline with a minimum of five year experience as a project toxicologist, with a demonstrated ability to manage multiple projects across various development stages
- Experience with biologics and small molecules is required
- Extensive regulatory toxicology experience and solid understanding of the drug-development process, including late stage and life cycle management for established compounds is required
- Excellent communication and presentation skills - Fluency in written and spoken English
- Energetic, driven and able to take initiative with a "can-do attitude"
- Results and delivery focused as well as a structured way of working
- Good problem-solving ability and analytical mindset
- Strong sense of personal accountability working independently as well as a strong ability to work in teams
Nice to have
- Experience with oligonucleotides, gene therapy, or combination drugs is a strong plus
- Board certification such as a DABT/ERT is a plus
- Experience in immunotoxicology is a plus
Your team
Preclinical Development and Translational Medicine (PDTM) Department
Benefits
- Comprehensive and industry-competitive total rewards package
- Competitive benefits package, to support the health and happiness of our staff
Apply
About Sobi
A specialized biopharmaceutical company dedicated to rare diseases
A global specialized biopharmaceutical company dedicated to rare diseases, with over 1,900 employees in more than 30 countries, turning research into ground-breaking treatments to help make medicine more accessible.
Mission
Developing and delivering innovative therapies to improve the lives of people who live with a rare disease
Key facts
- over 1,900 employees
- Biopharmaceutical
- Over 1,900 employees in more than 30 countries
- Specialized biopharmaceutical company dedicated to rare diseases
- Committed to the societies where we operate
What they value
- Care
- Ambition
- Urgency
- Ownership
- Partnership