Lundbeck is looking for a talented scientist with broad expertise in toxicology, chemistry and molecular biology to join the Department of Regulatory Toxicology & Safety Assessment.
The Regulatory Toxicology Department consists of 12 employees and is situated in Valby, Denmark. The department is responsible for safety assessment of new small molecules and biological entities, including outsourcing all types of nonclinical safety studies to Contract Research Organizations (CROs) around the world. The department works closely with other departments within the nonclinical-, clinical-, pharmacology-, regulatory-, and pharmaceutical areas at Lundbeck. The department assists Pharmaceutical Production (CMC) and Health, Safety & Environment (HS&E) units at Lundbeck in assessing the safety of chemicals, pharmaceuticals, impurities and intermediates used in pharmaceutical production. The department is part of the Drug Safety Division within Non-Clinical Safety Research.
- You will be an important player in a department that participates in the full development process of pharmaceuticals from early research to post-marketing commitments.
- You will be the main person responsible for supporting our production units with non-clinical expert assessments of pharmaceutical and chemical entities and you will provide advice on how to use the assessments in practice across all development projects.
- You will be the department’s representative in interdisciplinary teams and provide support in areas where regulatory guidelines require toxicology expert assessment.
- Your areas of responsibility will include toxicology assessment of drug impurities and contaminations, derivation of health-based exposure limits, nonclinical justification of specification limits, application of predictive toxicology tools and QSAR models, and monitoring of QSAR and nonclinical safety studies conducted at CROs.
- Furthermore, you will provide nonclinical input to regulatory documents and participate in interactions with regulatory health authorities.
- Dependent on your experience and educational background, you will be involved in evaluations of mechanisms of action of compounds, genotoxicology and cellular defence mechanisms.
Our preferred candidate has a relevant educational background in the natural sciences and preferably holds a PhD.
- You have experience with toxicology and an understanding of the cellular mechanisms involved in toxicology. Also, your overview and understanding allow you to advise and guide drug development projects on how to assess and interpret data.
- You understand in silico prediction systems and see the value in using these systems in the toxicological assessment of both pharmaceuticals and chemical products.
- You understand the regulatory and guideline framework.
- You have experience with deriving PDE, ADI and OEL values and with ICH M7 evaluations.
- Your personal drive enables you to communicate and seek solutions across the organization and to collaborate with both CMC and HS&E in their efforts to protect workers and environment.
- You are a team player and you contribute to a positive social atmosphere and an open and collaborative working environment.
Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).