Safety physician

GRANITE BIO is a private biotechnology company located in Basel (Switzerland).
GRANITE BIO is supported by top-tier investors with ~$100M raised to date. Based on fundamental research conducted over the last two decades, GRANITE BIO’s is pursuing a differentiated approach to transform inflammatory, autoimmune, and fibrotic conditions. Both our programs are first-in-class monoclonal antibodies for large market opportunities in Immunology and Inflammation. GRT-001, the lead asset, depletes inflammatory monocytes. It has just completed a Phase 1a trial in healthy volunteers and has shown favorable safety and pharmacodynamic effect.

The Phase 1b trial in patients with Ulcerative Colitis has just started. GRT-002 is an IL-3 neutralizing antibody that is thought to play an important role in type II inflammation.
Our company fosters an open, inter-disciplinary, diverse, international and creative working environment. We enable work-from-home options according to our internal workflows. The successful candidate will be highly motivated and enthusiastic with a positive “can do” attitude, attention to details and innovation, strong organizational and communication skills.

• 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

• You have an advanced medical degree (MD)
• You have at least 1 year of clinical research or clinical development experience in pharmaceutical/biotechnological industry, ideally in early clinical trials
• You can develop collaborative working relationships with physicians, expert consultants and contracted vendors
• You have a strong analytical mindset, excellent written/verbal communication skills
• You have exceptional attention to detail, organizational skills and judgment
• 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 are eager to work within a dynamic and fit-for-purpose Biotech environment
• 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 are an effective communicator that shares information transparently and strategically
• You are a…