Responsibilities:

• Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies
• Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials
• Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific presentations
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Responsible for review and analysis of clinical data including safety monitoring
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance

Requirements:

• M.D. degree; oncology or hematologist-oncologist
• Board certified Oncologist with an active US medical license
• Minimum 10 years total clinical research experience
• Knowledge of key opinion leaders in the areas of oncology/hematology highly desirable
• Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials experience with FDA interactions leading to drug approval strongly preferred
• Familiar with data processing methods plus general knowledge of clinical medicine, oncology and medical terminology
• Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
• Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance