Medical Officer (Oncology) at PSI CRO AG

Job Summary:
The Medical Monitor (Oncology) will actively participate in all aspects of Clinical Research, working collaboratively with the Clinical Study Team and contributing to the strategic planning and execution of Clinical Plans in Hematology and Oncology.

Responsibilities

• Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage
• 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

Desired Skills and Experience

• M.D. degree; oncology or hematologist-oncologist
• Board certified with an active medical license
• Minimum 10 years clinical 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