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
#J-18808-Ljbffr
