The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
Key Duties Include:-
Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role
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, 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 medical expertise / leadership in Proposal Development Teams for client bid pursuit meetings
Provide medical expertise to client across multiple channels and interactions such as:
Consultancy on protocol development or drug development program
Medical review of various documents, which might be audited by clients and regulatory agencies
Provide medical expertise and training to other Parexel colleagues
As appropriate, write clear, concise medical documents and 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.
Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications, conference attendance, etc
Support Business Development as needed
Successful applicants will be medically qualified based on successful completion of training at an accredited medical school and be Board-certified in Neurology w/ experience in Pediatric clinical patient care. Consideration will also be given to exceptional Adult Neurologists who possess the flexibility to serve as a medical monitor on both adult or pediatric trials. Past experience as a Physician in Industry or as a clinical trial investigator is preferred; however, strong candidates with an interest in clinical trials will also be considered.
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
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
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork.
@20% travel is required
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.