Clinical Safety Physician

vor 2 Wochen


Root, Luzern, Schweiz Novocure Vollzeit

Location:

Root D4, CH, 6039Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors.

TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death.

Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel.

Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, ovarian cancer and other types of solid cancers.

To support our team in Root, Switzerland we are looking for a

Clinical Safety Physician


In this role as Clinical Safety Physician you are responsible for implementing and overseeing all areas of safety monitoring and reporting for clinical trials.

You will join a dynamic team covering multiple oncologic indication trials globally. You will work closely with the Clinical safety specialists and report into the Associate Director of Clinical Safety.

Your responsibilities:

  • Responsible for Medical monitoring of clinical study safety data
  • Review and approve safety reports prior to submission
  • Assess, critically review and sign off serious adverse event (SAE) case reports
  • Ensure proper maintenance of the safety tracker/database
  • Responsible for the preparation/review of periodic safety reports
  • Responsible for answering regulatory safety queries
  • Provide sponsor oversight of SAE processing by outsourced vendors
  • Ensure compliant exchange of safety information between Novocure and its partners
  • Interface with Contract Research Organizations (CROs), and clinical operations team members
  • Provide sponsor oversight of CRO activities related to clinical safety
  • Train others on safety related topics internally and externally
  • Assist with development and review of all safety relevant content or safety relevant safety documents during clinical development (e.g. clinical study protocols, Investigator Brochures, safety management plans, coding review, etc.), including coordination and oversight of all safety relevant study set up activities for assigned indications.
  • Support the data preparation, set up and running of Data Monitoring Committees for clinical trials
  • Develop and maintain an expert understanding of the safety profile of the assigned product(s) as well as understanding of the relevant disease(s) under study
  • Ensure activities comply with the applicable Novocure Quality System requirements
  • Serve as SME for assigned indications/device types, support/back up other SMEs, when necessary.
  • Manage of the team of CSS/CSSSs
  • Train team members on study/indication/device specific topics

Your profile:

  • Medical degree (MD) or international equivalent required
  • Minimum of 2 years active clinical experience or 2 years of medical device/drug safetyrelated experience in multinational clinical trials preferred
  • Clinical or industry experience in oncology is an asset
  • Understanding of North America, Europe and Asia regulatory systems for clinical trials would be an advantage
  • Experience working per Good Clinical Practice
  • Proficiency with standard office skills, standard desktop computing programs and medical terminology
  • Highly organized and demonstrates understanding of workflow prioritization
  • Management (projects and people) experience would be an advantage
  • Fluency in English (verbal and written) is essential


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