Home-based with travel to site Initially 2 days a month growing to 10 days a month.
Our Client; based in the Netherlands has attracted significant investment and is now expanding its team.
They now require a part-time consultant to help them develop their nominated clinical development candidate; a first in class therapeutic antibody that targets Neutrophil Extracellular Traps (NET) formation; that is being developed towards a proof of concept phase 1b clinical study which is scheduled to enter clinical development in 2021. The role holder will define and develop the early clinical, and regulatory strategy for this lead programme.
They will provide the interface with regulatory authorities including preparation and submission of Regulatory documents for direct FDA and EMA interactions. In addition, they will support the CEO during Board of Director and Investor interactions as a member of Executive Management team as well as Organizing Clinical Advisory Board meetings and activities. The Head of Clinical Strategy will also provide medical, clinical and regulatory expertise for the development program and acts as a liaison with key opinion leaders and therapeutic area experts. The role holder will support intellectual property submissions and assist in performing due diligence exercises on in-licensed technologies or products where needed.
The role requires an Academic degree of MD, PhD, MD or only PhD. MD, PhD a plus with a proven track record in first in man, PoC and phase 2 clinical studies in biotech and pharma and experience of working on and advising clinical teams. A background in the development of therapeutic antibodies and IV/SC TPPs is sought as is expertise to include autoimmune diseases areas like RA, Lupus, Vasculitis, scleroderma, myositis and inflammatory indications like asthma, dermatitis. Broader experience a plus including cancer. Able to provide innovative designs of clinical studies. The role holder will be an excellent communicator with a good working knowledge of biostatistics.