Safety Physician / Safety Physicianess

Safety Physician – 7036 URA

Based in the biotech hub of Basel, Switzerland, our client is a private biotechnology company focused on developing first-in-class antibodies. Their dedicated team of immunology and inflammation experts takes immense pride in both their scientific breakthroughs and the collaborative process by which they achieve them. United by a common purpose, they strive daily to create innovative, transformative therapies that genuinely enhance patients' lives. The company promotes an open, interdisciplinary, diverse, international, and creative working environment.

They are currently seeking a Safety Physician with an advanced medical degree and experience in the early phases of clinical trials. This is a contract role based in their Basel office, offering flexibility in work hours ranging from 60-100% FTE.

Main Responsibilities:

• Perform medical monitoring and pharmacovigilance activities, including medical oversight of studies, eligibility checks, and safety data review.
• Conduct causality assessments.
• Review coding activities (e.g., MedDRA).
• Perform safety reviews of clinical and diagnostic data as part of case processing and aggregate reporting.
• Provide medical review of aggregate reports, such as Development Safety Update Reports (DSUR).
• Assist with generating project-specific procedures related to medical review activities.
• Contribute to the design, execution, and reporting of Phase 1 and Phase 2 clinical trials in the immunology and inflammation space.
• Collaborate with the medical team to develop clinical strategies.
• Ensure the generation and analysis of safety and efficacy data comply with GCP, SOPs, corporate strategy, and timelines.
• Work closely with cross-functional team members to ensure the planning and execution of clinical trials meet critical study milestones.
• Participate in the development of statistical analysis plans and the review, interpretation, and communication of clinical trial data.
• Co-author and develop clinical documents such as clinical study protocols and amendments, and review other clinical documents like safety management plans and medical monitoring plans.
• Collaborate with colleagues from Clinical Operations and the Clinical Biomarker Department to achieve clinical study program goals and milestones.

Qualifications and Experience:

• Relevant working or residency permit, or Swiss/EU citizenship required.
• Advanced medical degree (MD) required.
• Several years of clinical research or clinical development experience in the pharmaceutical or biotechnology industry, ideally in early clinical trials.
• Strong knowledge of clinical trial methodology and regulatory compliance requirements.
• Familiarity with Good Clinical Practices, Good Laboratory Practices, and clinical study design.
• A passionate, proactive medical professional inspired by a shared vision of bringing innovation to patients with unmet medical needs.
• Understanding of the framework and complexities of early-stage multi-center trials, with the ability to navigate various CRO/CDO-related operations.
• Experience in autoimmune diseases and/or inflammatory bowel disease (IBD) is desirable.
• Able to thrive as a leader or an active member within diverse teams.

Apply online using the form below. Please note that only applications matching the job profile will be considered.