Remote
Senior Toxicologist, Non-Clinical Pharmacology Scientist
About this role
Sobi is currently seeking an experienced Senior Toxicologist, Non-Clinical Pharmacology Scientist to join our Preclinical Development and Translational Medicine (PDTM) Department. The selected candidate will be responsible for the Toxicology and Non-Clinical Pharmacology activities within projects to support Clinical and Core Asset Teams for products under development or geographic expansion of established products. Key Responsibilities 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) 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, while experience with oligonucleotides, gene therapy, or combination drugs is a strong plus. Board certification such as a DABT/ERT is a plus Skills & Competencies Extensive regulatory toxicology experience and solid understanding of the drug-development process, including late stage and life cycle management for established compounds is required Experience in immunotoxicology is a plus 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.