Reporting to the Chief Medical Officer (CMO), the Medical Director (MD) will lead clinical development activities for new drug candidates across multiple therapeutic areas and indications. The MD will assume a hands-on role in the design and oversight of clinical trials, in close partnership with Clinical Strategy and Operations, Regulatory Affairs, Pharmacovigilance, and Clinical Research Organizations (CROs).
Profiel
* M.D. or M.D.-PhD degree with clinical research and 5+ years of experience in clinical development in the pharmaceutical or biotech industry, with 3+ years at the medical director level.
* Clinical experience as a respiratory physician and/or proven track record in developing respiratory products is required.
* Clinical experience and/or drug development record in additional therapeutic areas including hepatology or gastroenterology would be an asset.
* Hands-on experience and knowledge of the drug development process from Phases 1 to 3.
* Strong scientific knowledge in the fields of inflammation, fibrosis, and tissue repair/regeneration.
* Demonstrated ability to develop and implement global clinical development strategies involving key opinion leaders and according to the relevant regulatory framework.
* Experience with regulatory activities in the US and EU, as well as direct experience with IND/CTA filings, special designation submission (Orphan Drug Designation, Fast Track, PRIME, Breakthrough designations) is a plus.
* Excellent oral and written communications skills and ability to effectively communicate the Company’s R&D activities to the financial community and Pharma partners.
* Able to work effectively in a small dynamic organization; ability to assume multiple roles and responsibilities and meet stretch goals.
* Positive approach to work and ability to motivate team members to meet timelines and project goals is required.
* Ability to develop strong relationships with study investigators and key opinion leaders within the therapeutic area.
* High integrity and the ability to bring out the best in others, intellectually and interpersonally.
Aanbod
What we offer?
* The opportunity to develop pioneering science in a young biotech company.
* Challenging and innovative work environment as part of a driven team.
* Flexibility and responsibility based in Barcelona or Antwerp, with remote working options that can be tailored for you.
* Competitive salary and benefits.
* An agile and fast-paced environment.
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