Medical Director, Oncology

• Provide medical monitoring for assigned projects
• Function as medical representative on the project team
• Provide medical consultation as required or requested to client/sponsor or to other Parexel service groups
• Assume the role of Senior Technical Lead in selected circumstances
• Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
• Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor
• Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate
• Review documents written by various Parexel divisions for safety issues
• Review coding of adverse events and concomitant medications for accuracy and consistency
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents
• Attend and present material, as requested, at meetings within Parexel as well as extra-company external meetings and conferences

• Medically qualified based on successful completion of training at an accredited medical school
• US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care
• Excellent interpersonal skills
• Excellent time management skills
• Excellent verbal and written medical communication skills
• Excellent standard of written and spoken English
• A flexible attitude with respect to work assignments and new learning
• The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• A willingness to work in a matrix environment and to value the importance of teamwork
• The ability to travel 10% domestically and/or internationally as needed

Past experience as a Medical Monitor, Physician in Industry, or as a Clinical Trial Primary Investigator or Sub-Investigator