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Director Preclinical Development

Become the toxicology expert in a successful biotech company

Y-mAbs is a rapidly growing late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer. The company has a broad and advanced product pipeline, including two pivotal-stage product candidates, which targets tumors, that have the potential to be launched this year.

As Director Preclinical Development you will be responsible for managing or participating in the nonclinical safety activities on one or more of Y-mAbs development projects, supporting a growing pre-clinical pipeline in early clinical development.

You will become part of a highly skilled team of nonclinical scientists leading the scientific understanding of the safety of novel therapeutics in a company dedicated to finding cures to cancer. This is a pivotal role in the nonclinical sciences group, and you will be expected to contribute significantly to growing the toxicology expertise within the organization. The position is newly established and you will report to the Chief Scientific Officer.

Your main tasks among others are:

  • Foster continued development of the group’s research and regulatory toxicology expertise through conduct of non-GLP and GLP toxicology studies
  • Provide expertise to understand the mechanisms of toxicity observed non clinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients
  • Act as a nonclinical team representative responsible for the nonclinical safety strategy of novel target/therapeutic candidates
  • Present data and interpretations in written and oral form to regulatory bodies to enable optimal clinical development and registration of novel drugs
  • Assist in developing and delivering an overarching strategy for the delivery of toxicology data, which may include internal resources and/or external partners
  • Build collaborative networks internal and external to the company to ensure rapid communication and cross-functional evaluation and investigation of emerging safety issues
  • Responsibility for nonclinical safety regulatory documents, e.g. INDs, IMPDs, DSURs, annual updates, labels, and eCTD documents Modules 2.4, 2.6.1-7, and Module 4 for selected programs

You have min. 6 years of drug development experience working as Toxicologist in the biotech or pharmaceutical industry. Ideally, you have solid experience in conducting toxicology studies and some experience in pre-clinical pharmacology. Your educational background is Doctor of Veterinary Medicine or another relevant master’s degree in life science. A PhD is preferred. Furthermore, you speak and write English at a professional level.

It is an advantage if you have the following experience: worked with aspects of in vitro safety pharmacology (incl. immunotoxicology, cytokine release, cytotoxicity, Fc mediated effects, immunophenotyping, receptor occupancy), worked with cancer biology, bispecific antibodies or oncology and have knowledge of PK aspects. 

You are a person with the ability to collaborate with both internal and external partners. You are flexible, open to challenges and you thrive in a dynamic and entrepreneurial research environment. In addition, it is important that you are passionate about working in a novel therapeutic area.

Y-mAbs offers an exciting opportunity in a successful biotech company in which you will have a high degree of influence on your own job. The position will allow you to create a sustainable footprint while developing professionally.

Travelling: 15 – 20 days/year

Domicile: Hørsholm

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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