Safety Physician – URA

Based in the biotech hub of Basel, Switzerland, our client is a private biotechnology company developing first-in-class antibodies
. Their passionate team of immunology and inflammation experts takes immense pride not just in their scientific breakthroughs, but in how they achieve them. Driven by a shared purpose, they focus every day on creating innovative, transformative therapies that truly improve patients’ lives
. They foster an open, inter-disciplinary, diverse, international and creative working environment

For their team in Basel, they are looking for a Safety Physician with an advance Medical Degree and experience in early phase of clinical trials. This is a Contract role to work from their Basel office with a flexibility of 60-100% FTE.

• Perform medical monitoring and pharmacovigilance activities (such as medical oversight of the study, eligibility checks, review safety data)
• Provide causality assessments
• Review of coding activities (MedDRA…)
• Perform safety review of clinical and diagnostic data as part of case processing and aggregate reporting
• Provide medical review of aggregate reports (DSUR…)
• Assist with generation of project specific procedures (medical review activities)
• Contribute to design, execution/conduct and report of Ph1/2 clinical trials in I&I space
• Contribute to medical team and clinical development strategy
• Ensure that safety and efficacy data is generated and analyzed according to GCP/SOPs, corporate strategy and timelines
• Work closely with cross-functional team members to ensure planning and execution of clinical trials to meet key study milestones
• Contribute to the development of statistical analysis plan, and in the review, interpretation, and communication of clinical trial data from clinical trials
• (Co)-Author and develop clinical documents like, clinical study protocols and amendments and review other clinical documents like safety management plan, medical monitoring plan
• Work closely with colleagues from Clinical Operations and Clinical Biomarker department to deliver clinical study program goals and milestones

• Relevant working/residency permit or Swiss/EU-Citizenship required
• You have an advanced medical degree (MD)
• You have several years of clinical research or clinical development experience in pharmaceutical/biotechnological industry,
  ideally in early clinical trials
• You have strong knowledge of clinical trial methodology, regulatory and compliance requirements of clinical trials
• You have knowledge of Good Clinical Practices / Good laboratory Practices and clinical study design
• You are a talented, pro-active and passionate medical professional, inspired by our shared vision to bring innovation to patients with unmet medical needs
• You understand the framework and complexities of early clinical multi-centre trials and can deal with various CRO/CDO-related ways of working
• You have ideally experience in the autoimmune disease and/or IBD (I&I) space
• You thrive leading or being an active member of large or small diverse teams