Medical Director, Endocrinology

Key Accountabilities

• 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

Additional Responsibilities

• Review all individual adverse experience reports for accuracy and clinical importance
• 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
• Summarize adverse experiences as required by FDA or the sponsor, depending on the contract
• 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 with the project team, sponsor, investigator, and FDA
• 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 for clients/sponsors or in conjunction with clients/sponsors and in conjunction with other Parexel divisions
• Attend and present material, as requested, at meetings within Parexel as well as extra-company external meetings and conferences

Education, Skills, Knowledge and Experience

• Be a MD Endocrinologist (or equivalent international credential)
• Have extensive clinical experience treating adult patients with Obesity, MASH/NASH, and Diabetes (highly preferred)
• Past experience as a Physician in Industry or as a Clinical Trial Primary Investigator or Sub-Investigator (highly preferred); however, consideration will be given to exceptional candidates with an interest in transitioning to Industry (candidate experience will determine Associate Medical Director, Medical Director or a Senior Medical Director role)
• Have excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
• Have excellent time management skills
• Have excellent verbal and written medical communication skills
• Have an excellent standard of written and spoken English
• Have 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 up to 20% domestically and/or internationally as needed