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Director Pre-Clinical and Toxicology

Can you direct the preclinical development of an exciting and innovative new technology?

 

Biograil is looking for a highly motivated Director Pre-Clinical and Toxicology, who will lead and drive preclinical toxicology strategies and activities and support ongoing clinical programs.

As Director Pre-Clinical and Toxicology at Biograil, you will have a broad area of responsibility and an opportunity for a large impact on the lives of patients.

With direct report to the CDO, you will be part of the team and act as a subject matter expert on Toxicology. Moreover, you will play a key role in the oversight and monitoring of toxicology studies conducted at Contract Research Organizations (CROs) or in collaboration with partnership companies.

Your main tasks are:

  • Lead ongoing portfolio programs on pre-clinical pharmacology and toxicology matters
  • Lead ongoing testing of drug delivery devices and evaluate safety and PK data
  • Formulate and lead preclinical toxicology strategies to integrate into Bio-Grail’s future pipeline
  • Engage and collaborate with partnership companies on selected projects
  • Act as subject matter expert on GLP toxicology
  • Designing, monitoring, reporting, and interpretation of exploratory and regulatory toxicology studies (in vivo/in vitro/non-GLP/GLP) conducted at CROs
  • Manage collaborations with pre-clinical CROs and selection of new vendors
  • Communicating data internally and contributing/authoring of preclinical safety sections of relevant regulatory documentation
  • Engaging with the Research team to ensure adequate species selection and qualification
  • Author high-quality regulatory documents

Your qualifications include several years of experience within toxicology from the pharmaceutical/biotechnology industry or as a CRO. Experience with both pre-clinical and clinical activities is preferred. Moreover, experience with devices is desired. You have previously worked with pre-clinical CROs and have experience in interaction with regulatory authorities. Preferably, you have experience with pharmacology, as the role will contain some pharmacological elements.

You have a Master’s Degree in Biology, Human Biology, DVM, or another relevant scientific education. A Ph.D. is preferred but not a requirement.

You are a person who takes ownership and drives the area as a highly motivated team player appreciating responsibility and autonomy. You thrive in an entrepreneurial research environment with an open and accommodating approach and prioritize and organize processes in a lean manner, both independently as well as in teams. Thrives in a multi-faceted environment and enjoys working in teams with a collaborative approach to external partners. You have high ethical standards and great attention to detail, where quality is always at the core.

Biograil Therapeutics offers an exciting career opportunity where you will have room for influencing your role and being involved in different projects as the pipeline is developing.

Traveling: Approx. 10 days.

Domicile: Roskilde.

For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Client Manager Gert Vium Andersen, Unique Human Capital on M: +45 42 95 08 83. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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