Medical Sciences Opportunities at Parexel
Medical Director - Cell & Gene TherapyJob ID 36999BR USA - Any Region - Home Based
We are currently seeking Board Certified physicians to join Parexel as Medical Directors with a focus on cell and gene therapies.
As a Medical Director at Parexel focusing on cell and gene therapy, you will 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; and assume the role of Senior Technical Lead in selected circumstances.
In addition, you will also:
•Meet with clients for early engagement and strategy discussion including industry and investigator meetings.
•Help coordinate training and standard operating procedures for cell and gene therapy trials.
•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 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 meetings ie. Investigator Meetings.
Successful applicants will be Board certified with clinical trial experience. Training for this role may include hematology and oncology, neurology, cardiovascular disease, infectious diseases, neurology, or others to be considered. Experience in industry is a plus. Trained in cellular therapies, including but not limited to, CAR-T cells and be familiar with the fundamentals of gene therapy trials.
@25% travel is required
EEO DisclaimerPAREXEL is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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