Clinical Trial Physician – Phase I, EMEA

• Provide medical leadership to study teams
• Create clinical trial protocols using the latest scientific information
• Contribute to site selection and review and approval of study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents
• Perform real-time medical monitoring of clinical studies
• Ensure medical validity of primary endpoints and study subject safety
• Proactively escalate and correct medical issues in consultation with the Global Medical Indication Lead
• Interpret clinical trial data for regulatory documents, manuscripts, and other publications
• Act as medical point of contact for internal and external stakeholders
• Interact with investigators and answer questions from IRBs and Health Authorities
• Prepare and present material to study executives and independent safety committees when applicable
• Provide medical training to site staff and CRA training in new indications
• Ensure compliance with medical aspects of studies by applying relevant SOPs and GCP
• Collaborate with cross-functional study team members to clarify medical risks, issues, and results
• Harmonize answers, eligibility decisions, and protocol deviation decisions when multiple physicians work on a protocol

• Medical Doctor
• Relevant specialty education preferred, such as neurology, hematology, dermatology, immunology, rheumatology, internal medicine, or pediatrics
• Some experience in industry preferred
• Excellent English, written and spoken
• Ability to travel
• Proven interpersonal skills to lead a study team and provide medical advice and evaluations
• Proactive problem-solving and negotiation skills
• Strong communication skills for collaboration in a cross-functional, matrix structure
• Knowledge and application of relevant SOPs and GCP
• Ability to exercise judgment and escalate issues immediately when needed

• Healthy and balanced work environment
• Collaboration and professional development opportunities
• Ability to travel