Safety Physician (7036)

Contract

Posted 3 weeks ago

Recruiter: Usha Rao

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