Senior Regulatory Toxicologist

Are you passionate about making a real difference in the lives of millions of people affected by diabetes, obesity, cardiovascular diseases, NASH, and other chronic conditions? Novo Nordisk A/S is seeking an experienced and inquisitive scientist with a strong digital skill set to join our team for a one-year temporary position in Denmark.

The position
As a Senior Regulatory Toxicologist, you will be an integral part of our versatile team, operating in a challenging and ever-evolving environment where adaptability, curiosity, and effective prioritization are key. Your primary responsibilities will include:

• Preparing toxicological risk assessments of drug product and process-related impurities, as well as evaluating extractables & leachables from production equipment and primary packaging materials, while maintaining a balance between regulatory requirements and scientific rigor.
• Engaging in toxicological assessment and communication of environmental and occupational safety of drug candidates for production facilities, along with the biological evaluation of devices.
• Leveraging literature data, in silico models, in-vitro models, and biological testing to conduct toxicological safety assessments, overseeing studies conducted at internal or external laboratories or by in-silico consultants.
• Actively contributing to process improvements and the implementation of digital solutions.

This position requires physical presence with the option for remote work on select days.

Qualifications
To thrive in this role, you should possess:

• A master's degree or PhD in chemical/biochemical, life sciences, or a related field, coupled with a solid understanding of toxicology.
• At least 3 years of experience in toxicological risk assessment, with a strong familiarity of guidelines and regulations, including ICHM7, ICHQ3C, and ICHQ3D.
• Proficiency in in-silico evaluations and experimental work, either through direct involvement or collaboration with contract research organizations.
• The ability to manage multiple tasks, diverse stakeholders, and tight deadlines without compromising on quality.
• An innovative mindset, coupled with a keen interest in exploring digital solutions and driving process enhancements.

We encourage individuals who meet most of these qualifications to apply, as we value diverse experiences and perspectives.

About the department
Join the dynamic Toxicology Development Projects department, which collaborates closely with our sister department as a Toxicology Centre of Excellence, collectively responsible for the non-clinical safety assessment of drug development candidates. Located in Måløv near Copenhagen, you will join a team of 6 professionals dedicated to various essential tasks, including the performance of biological evaluations of medical devices, occupational and environmental health & safety evaluations of drug candidates, and toxicological risk assessment of impurities, excipients, extractables, and leachables from process equipment and drug primary packaging material. Our area is characterized by an open, sharing, collaborative, and ambitious atmosphere, offering ample opportunities for professional growth and development.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 61,000 employees around the world to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.

Contact
For further information, please contact Julie Mangor Lovmand, Head of Department - Toxicology Development Projects, at +45 30757879.

Deadline 
5 January 2025. 

Please note that interviews will start in January 2025. 

You do not need to attach a cover letter to your application – just include a few sentences about why you are applying in your CV. Please also avoid the use of photos in your CV. This makes for a better and less biased process. 
 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.