Senior Toxicologist, Non-Clinical Pharmacology Scientist

Job description

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. Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. This position is open to be located in Europe.