Google Cloud PlatformGCPGoogle CloudCommunicationCollaboration
About this role
Role Overview
Serve as a medical responsible on clinical trial(s), overseeing execution of clinical trial activities in assigned projects
Engage and work with Key Opinion Leaders or Scientific Advisors in the relevant therapeutic area to help develop scientific rationale for clinical trials
Develop and/or oversee the preparation of clinical development plans, study concept sheets, study protocols or regulatory documentation in collaboration with clinical and project team members for assigned indication(s)/products or with external partners for collaborative studies
Actively contribute to or oversee medical writing of medical sections of study protocols, investigator brochure and other regulatory documents
Manage the clinical team supporting the clinical trial
Oversee all aspects related to the scientific and medical risk in collaboration with the safety representative and other relevant stakeholders
Support the review, analysis and interpretation of study data
Support communication of study results as assigned
Requirements
Medical Degree (mandatory)
Neuroimmunology experience is a must
Myasthenia gravis experience would be a big plus
Able to communicate effectively in English
Experience leading protocol development
Requires substantial professional experience in related TA/indication including clinical trials
Professional experience in the execution of clinical trials as medical responsible (3+ years)
Previous experience in medical monitoring, medical data review, eligibility review during recruitment, presentations at investigator meetings and trainings, protocol writing, regulatory responses
Experience in design, set up, conduct and evaluation of clinical trials
Experience working in a cross-functional multi-site team environment
Working knowledge of GCP, ICH, US FDA and EMA regulations
Tech Stack
Google Cloud Platform
Benefits
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways