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Full-time Clinical Trial Leader

at Santhera Pharmaceuticals in Basel CH

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases. In September 2015, our leading product Raxone® (idebenone) received European Marketing Authorization in the treatment of patients with LHON (Leber's Hereditary Optic Neuropathy). Raxone® is not only the first and only medicine approved for this condition, but it is also the first medicine approved for any mitochondrial disorder.

The company currently develops Raxone® in other areas of high unmet medical needs, like the treatment of Duchenne Muscular Dystrophy (DMD) and Primary Progressive Multiple Sclerosis (PPMS). In addition, Santhera’s pipeline includes omigapil, an investigational drug with anti-apoptotic properties, a compound in development to address unmet medical needs for patients with Congenital Muscular Dystrophy (CMD). For more information, please visit the company's website

Scope of Work

The role reports to Head of Clinical Operations and works closely with CRO, clinical development functions and medical affairs. This is a highly visible role in the organization and will manage key internal and external stakeholders.

The overall scope of the role is to plan, execute, maintain oversight and report on clinical trials, from planning, vendor selection (if applicable) and site feasibility, through study close out. Lead and provide direction to the cross-functional Study Management Team (SMT) to ensure all trial outputs from protocol development to final clinical study report (including archiving of the Trial Master File) are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines.

The responsibilities for this role include the following:

  • Provide clinical operations related input to the Clinical Development Plan
  • Ensure that the design of clinical studies under area of responsibility is in line with the objectives defined in the...
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Published at 06-06-2017
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