Orphazyme is looking for a Senior Scientist/Principal Scientist to join Nonclinical Safety. At Orphazyme, we develop paradigm-changing drugs for the treatment of severe, debilitating neurodegenerative and neuromuscular orphan diseases such as Amyotrophic Lateral Sclerosis and lysosomal storage disorders.
This is your opportunity to join a dedicated team of professionals and become an important part of a progressive and innovative biotech company based in Copenhagen. It is also your chance to get the opportunity to be involved in both early and late stage nonclinical development.
Your Key Responsibilities:
- Design, monitor and report safety pharmacology and toxicology studies outsourced to CROs
- Manage interactions with CROs to ensure high quality and on-time execution of nonclinical safety studies
- Integrate data from nonclinical safety studies and other sources to support safety assessments of our development candidates
- Write/give input to/review nonclinical sections of regulatory documents such as meeting packages, IND, CTA, IB, NDA and MAA
- Assess safety of impurities, excipients etc. and provide miscellaneous support to CMC
- Deliver and communicate results to project teams, and contribute to decision making by providing expert input
- Collaborate with colleagues and ensure coordination across Discovery, Clinical Safety, Clinical Pharmacology, Regulatory Affairs etc. to ensure patient safety – if you have a relevant background and experience, nonclinical project management may also be part of your responsibility
- Life science degree combined with a solid understanding of physiology and pathology – experience within safety pharmacology will be an advantage
- At least 5 years of experience within safety pharmacology and/or toxicology, ideally within the pharmaceutical industry
- Experience with nonclinical development including involvement in the nonclinical safety assessment of new drug candidates
- Experience in collaborating with CROs and monitoring nonclinical studies
- Knowledge about SEND
- Knowledge about relevant regulatory guidelines and GLP
- Excellent written and spoken English skills
- Focus on providing high-quality, timely results
- Team player with strong communication skills
- Proactive, flexible and easily adaptable to new situations
At Orphazyme you will be part of a stimulating and informal working environment and an organisational culture that emphasises care, courage, integrity, and perseverance. You will collaborate with various departments and project teams and you will work with a varied array of tasks and challenges. Orphazyme is growing rapidly and the opportunities to contribute and influence are many.
Please apply online with your application and CV. If you have questions about the position, you are welcome to contact Director of Nonclinical Safety, Charlotte Dujardin Weimann at +45 3143 0017.
25 April 2021, but applications will be reviewed and interviews held on a rolling basis.
Orphazyme is a Danish biopharmaceutical company with a late-stage drug pipeline, developing new treatment options for orphan protein-misfolding diseases. The highly motivated and talented team of professionals are dedicated to the development of innovative therapeutic approaches to severe diseases and cooperates with the research community worldwide. Orphazyme’s pipeline comprises three potential registration studies, with the first potential marketing authorisation expected in 2021.
We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.