Chief Medical Officer for Arthex Biotech
ARTHEx Biotech S.L. is a private company, spin-off company from the University of Valencia focused on the development of Antisense RNA treatments for genetic diseases. The founders of the company are Dr. Beatriz Llamusí and Dr. Ruben Artero. The first product will be the development of a new RNA therapy (anti-miRNA) addressed to the treatment of myotonic dystrophy (DM). DM is the most common muscular dystrophy in adults and it is a highly disabling disease with symptoms involving the skeletal musculature, the heart, and the nervous system. The business model proposed is based on an open innovation model in which the biotechnology company develops the products until phase 2 or 3, and then licenses them to pharmaceutical multinationals with the capacity to complete the development studies more advanced and its commercialization.
We are looking to hire a full-time Medical expert as the Chief Medical Officer (CMO) of the company. He/She will be responsible for strategic development and tactical implementation of the clinical studies for our research programs. Experienced in clinical and Regulatory requirements and clinical studies. The CMO will be reporting to the CEO.
- Develop service plans and resources to achieve the objectives of the Drug Development in terms of regulatory.
- Together with external consultants will be responsible for supervising of the preparation of the IND application
- Be up-to-date with preclinical and clinical guidelines that affect the drug development pipeline
- Establish methods of work within the regulatory
- Review incidents associated with regulatory issues the Drug Development
- Represent the company in different fields, including meetings with potential investors
- Keep the human team of the company motivated and involved, providing it with the necessary tools and resources to optimize its work
- Lead and implement the clinical direction of ARTHEX in coordination with our medical and scientific advisors
- Lead the clinical operations of the company.
- Medical degree
- Neurologist with experience in clinical monitoring of neuromuscular diseases will be a plus
- +3-5 years experience in clinical operations
- Relevant experience in similar positions. Expertise in regulatory affairs in orphan drugs
- Previous experience in similar positions at start-ups would be appreciated
- Knowledge of FDA and EMA guidelines
- Regulatory Affairs Experience with orphan drugs
- Experience in fund rising from VCs
- Previous experience in the design of clinical trials
- Previous experience collaborating with empowered patient associations or academic clinical research networks
- Planning and organization
- Autonomy and initiative
- Europe based US based, remote.
- Open to travel to Valencia monthly. Phase 1 will be developed in the USA
- English native or fluent. Spanish fluent will be a plus
Patricia de Castro: