Careers

A Career AT Orphazyme

Orphazyme is a development stage biopharmaceutical company. Our highly motivated and talented team of professionals is dedicated to the development of innovative therapeutic approaches to severe diseases, and cooperates with the research community worldwide.

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Current VacancIES

Nonclinical Safety Scientist

Orphazyme is searching 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, sporadic Inclusion Body Myositis, 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 rare opportunity to be involved in both early- and late-stage nonclinical development as Orphazyme is currently preparing for submission of an NDA/MAA in H1 2020 in parallel with developing a new series of heat-shock protein (HSP) amplifying drugs based on our expertise and know-how about the convergence of HSPs, protein aggregation, and cellular recycling systems and how these can be targeted for therapeutic benefit.

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/review nonclinical sections of regulatory documents such as IND, CTA, IB, NDA, and MAA

· Assess safety of impurities, excipients, etc.

· Deliver and communicate results to project teams, provide input, and contribute to decision making

· Collaborate with colleagues in Clinical Safety, Clinical Pharmacology, etc. to ensure patient safety

Your profile:

· Veterinary or life science degree, combined with a solid understanding of physiology and pathology

· At least 5 years’ 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 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

We offer

At Orphazyme you will be part of a stimulating and informal working environment. You will collaborate with various departments and project teams and you will work with a varied array of tasks and challenges.

Application

Please apply by sending an email marked “Nonclinical Safety Scientist” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Director of Nonclinical Safety, Charlotte Dujardin Weimann at +45 31430017 or at cdw@orphazyme.com.

Deadline

October 21, 2019.

Our company offers exciting and meaningful career opportunities in an adaptable work environment. We are looking for new colleagues to join our team on the journey towards bringing life-changing therapies to patients who have no satisfactory treatment options today.

We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.

DMPK Scientist

Orphazyme is searching for a Senior/Principal DMPK Scientist. This is your opportunity to join a dedicated team of professionals and become an important part of a progressive and innovative biopharmaceutical company.

We seek a dedicated DMPK Scientist to support our non-clinical and clinical development activities.

Your key responsibilities will be compilation of ADME data to support our development candidates in cooperation with CROs and in accordance with current regulatory guidelines.

You will also be involved in project teams, representing DMPK, holding the primary responsibility to drive the project forward with focus on ADME and DDI strategy and carry out decisions made by the project team.

Key responsibilities

· Serve as the DMPK representative to ensure effective application and integration of ADME studies in support of discovery and development programs.

· Identify critical ADME/PK needs and propose strategies.

· Design and oversee studies, analyze, review and summarize results, integrate ADME and PK.

· Deliver and communicate results to project teams, provide intellectual input, and contribute to decision making.

· Manage interactions with external CROs to ensure high quality and on-time execution of ADME studies.

· Review experimental procedures, data acquisition and analysis.

· Coordinate operational logistics among in-house functions and external vendors.

· Work with development teams to support DDI studies

· Ensure timely preparation of contracts; review and process invoices for approval.

· Write and review relevant sections of regulatory documents.

Education & requirements
Scientific degree in Pharmaceutical Sciences, Pharmacology, or related disciplines with at least 5 years’ relevant experience in the pharmaceutical industry or CROs.

In-depth understanding and strategic application of in vitro and in vivo ADME assays, methods, and models. Expertise in PK analysis (NCA/modelling) is a plus.

Expertise in managing CROs and sound knowledge of regulatory guidelines on bioanalysis, GLP practice, and DDIs.

Strong analytical, organizational, and communicative skills, and a consummate team player.

We offer
At Orphazyme, you will be part of a stimulating and informal working environment. Here, you will collaborate with various departments and project teams. You will work with a varied array of tasks and challenges.

Application
Please apply by sending an email marked “DMPK Scientist” with your application and CV to career@orphazyme.com. If you have questions about the position, you are welcome to contact Director of DMPK & Clinical Pharmacometrics, Thomas W. Anderson at +45 31430019 or twa@orphazyme.com.

Deadline
September 10, 2019.

We encourage anyone interested in a job to apply, irrespective of gender, age, race, religion, or ethnicity.

A Career AT Orphazyme

Current VacancIES

Nonclinical Safety Scientist

DMPK Scientist

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