Safety Physician (7036)

Safety Physician – 7036 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

Main Responsibilities:

·      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

 

Qualifications and Experience:

·      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