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Senior R&D Project Leader (PK-PD)

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Biotech, Biotechnology - Gosselies

Founded in 2018, Apaxen develops a unique and innovative class of anti-inflammatory therapeutics with a primary focus on pulmonary arterial hypertension (PAH).

The company plans to perform the preclinical development of its lead compound for the treatment of PAH through the clinics. Concurrently, Apaxen will design and develop the 2nd and 3rd generation of its lead compound in the field of chronic inflammation, oncology and neurology. Apaxen products has the potential to revolutionize the standard of care of PAH and other diseases related to chronic inflammation.

Apaxen has recently raised 3,3 million € through a Serie A funding process and is located in the Brussels South Charleroi Biopark.

In order to support the expansion of the dynamic team in Belgium, we are looking for a (m/f):

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Senior R&D Project Leader (PK-PD)

Responsibilities:

As Senior Project Leader in charge of non-clinical activities you identify the relevant studies for Apaxen drug candidates. You work closely with external partners, like CRO, to carry on the non-clinical PK/PD and safety studies on Apaxen drug candidates in the best possible manner l. You report to the CEO.

Your main responsibilities are as follows:

  • You define, plan and monitor all the PK-PD and safety studies necessary for the CTA/IND filing of the lead Apaxen drug candidate.
  • You manage the non-clinical PK-PD-safety studies, mostly performed by CRO, and collaborating research centers. This will include:
    • Proposing the studies, reviewing and challenging the proposed study protocols,
    • Closely monitoring the progresses of the studies,
    • Reviewing and the challenging of the draft study reports.
  • You take part in the writing of regulatory documents and take the lead on the non-clinical part for CTA/IND filing.
  • You maintain close interactions with the team in charge of the CMC part of the project
  • You actively monitor research projects (outsourced) of Apaxen.
Profile:
  • You hold a PhD or PharmD or MD.
  • You have a strong knowledge of drug development, with 5 to 15 years of experience.
  • You have experience in carrying NCE up to CTA/IND filing.
  • You are willing to work within a start-up and dynamic structure, a previous experience in the biotech industry is a plus.
  • You are a team player with strong interpersonal skills.
  • You are result-oriented and focus on your objectives.
  • You are rigorous, independent, pro-active with a problem-solving mindset.
  • You are a team player with a good oral and written communication.
  • You are fluent in French and English.
Offer:
  • A challenging and rewarding position within a Start-up.
  • The opportunity to join a company developing a unique and innovative anti-inflammatory for pulmonary diseases.
  • To work in a human-sized, innovative, collaborative and dynamic company.
  • An attractive salary package in line with your experience.
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