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reference: 4877724

documentId: 4877724

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lastModificationDate: 1536743886816

stillingsbetegnelse: Principal Scientist – Toxicologist

jobbeskrivelse:

Do you want major responsibility and freedom to perform in a top class team?

Do you have what it takes to work across scientific evaluation of potential in-licensing products, safety of impurities and toxicological project work in cross-organisational R&D teams? If you at the same time are motivated by major responsibility, freedom to perform and influence on high level and business critical decisions, this is the job you have been looking for. You will enter LEO Pharma in the maybe most exciting period in the company’s history and contribute to fulfilling our ambition of becoming the world’s preferred dermatology care partner.

 

Studies at CRO’s, nonclinical documentation and assessments related to existing 

As Toxicologist in our Preclinical Development team your main tasks will be to:

• Set up and monitor safety pharmacology and toxicology studies with NBE and NCE drug candidates outsourced to CRO’s 
• Perform literature searches in data bases like Medline, Embase, Toxnet databases etc.
• Write/review nonclinical sections of regulatory documents such as IND/CTA/IB/NDA/MAAs 
• Provide response to regulatory queries related to preclinical data 
• Carry out safety qualification of impurities and excipients
• Evaluate safety-aspects of potential in-licensing opportunities 
• Deliver toxicological (hazard and risk) support to colleagues 
• Support Pharmacovigilance and Regulatory Affairs

As part of the above you will represent Preclinical Development in cross-functional project groups and participate in meetings with authorities.

 Your background

You have more than 10 years’ experience within toxicology/safety evaluation of which at least 5 years’ must be from working in the pharma industry. This has provided you with extensive experience within GLP and regulatory guidelines as well as with cross-functional and cross-cultural project work. Your solid experience covers:

• Safety evaluations of impurities identified in production processes and of extractables and leachables from devices and packaging material
• Setting up and monitoring non-clinical studies at CRO’s of primarily NBEs, but preferably also NCEs
• Evaluation of in-licensing opportunities including due diligence
• Toxicological literature search and knowledge of In Silico methods (QSAR) 
• Preparation of regulatory documents such as IB, CTA, IND, NDA/MAA etc.

To succeed, you must thrive in a very dynamic environment where the only constant is change. Additionally, you must like to be trusted with major responsibility where you are the one that make the necessary decisions related to your projects and tasks. This calls for your ability to work independently. At the same time you must be able to create results via an open minded and constructive dialogue with due respect to the perspectives from colleagues and partners with backgrounds different from yours.

 Your new team

You will join 9 highly skilled and experienced Scientists in Preclinical Development at LEO Pharma’s headquarters in Ballerup, Greater Copenhagen. We are specialised in toxicology and bioanalysis providing you with ample opportunities for competent feedback. We work in an informal and friendly atmosphere characterised by trust and helpfulness.

We look forward to receiving your application.

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jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2310

abstractJV_contact_0:
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positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR