Associate / Medical Director - Nephrology

4 weeks ago

Northeast, United States Parexel Full time

Join Parexel for an impact on global health way beyond the possibilities of an individual

Working at Parexel's Medical Sciences team is about enhancing your understanding of diseases and the drug development process. It's about learning from colleagues with multiple specializations and with experience of how practices vary in different countries. You proudly share your knowledge to grow together and contribute to new successful treatments to change a patient's life. Working at Parexel offers you exposure to dozens of therapeutic areas, different top pharma clients, and emerging biotech companies. You will utilize cutting-edge science to uncover new insights and answer challenging questions about the most common diseases, but also rare and ultra-rare diseases that you might have just read about in your training. Working with your outstanding colleagues in a multicultural team helps you regain work-life balance because you'll support and coach each other. This is backed up by your gained flexibility and control of your schedule compared to working in a clinical or an academic setting.

As an Associate / Medical Director at Parexel, you will provide medical monitoring for assigned projects, function as the 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.

You will:

Provide medical expertise / leadership in Proposal Development Teams for client bid pursuit meetings. Deliver all medical support required for successful delivery of projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) Review all adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness. Review reports provided to sponsors and the FDA or other regulatory agencies on a regular basis, summarizing adverse experiences as required. Review summarized listings of safety data, including adverse events, laboratory results, and vital signs, to assess for any trends in safety data and ensure adherence to the study protocol. Perform review of medical and study related documents for medical accuracy, completeness and clarity Review industry coding of adverse events and concomitant medications and medical history for accuracy and consistency. 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. Support Business Development as needed. Successful applicants will be medically qualified based on successful completion of training at an accredited medical school and be US Board-certified in Nephrology. While the focus will be adult clinical trials, one may be asked to serve as a medical monitor on pediatric trials, when needed. Past experience as a Physician in Industry or as a clinical trial investigator is highly preferred; however, strong candidates with an interest in clinical trials will also be considered. Applicant should have: Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts. Exceptional time management skills Proficient verbal and written medical communication skills. Fluency in 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. @15% domestic and/or international travel is required Candidates who live in the Eastern or Central region of the United States are highly preferred to meet the current needs of our clients.
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