Reporting to the Chief Medical Officer (CMO), the Medical Director (MD) will lead clinical development activities for new drug candidatesacross multiple therapeutic areas and indications. The MD will assume a hands-on role in the design and oversight of clinical trials, in close partnership Clinical Strategy and Operations, Regulatory Affairs, Pharmacovigilance, and Clinical Research Organizations (CROs).
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 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 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 therapeutic area. High integrity and the ability to bring out the best in others, intellectually and interpersonally De uitvoerbaarheid van het project bestuderen Technische en technologische voorstellen uitwerken De methodes en middelen voor studies en ontwerp en hun uitvoering bepalen Wetenschappelijke, technologische, technische, reglementaire, ... informatie opvolgen en actualiseren Domein: Onderzoek Domein: Ontwikkeling
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. F lexibility 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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