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Associate / Medical Director, Clinical Neurosciences

4 months ago

Southeast Fairbanks, United States Parexel Full time

Parexel's Clinical Neurosciences (CNS) Team is hiring

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

As an Associate / Medical Director at Parexel, 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.

You will:

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 roleReview all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousnessProvide 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 contractReview 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 FDAReview documents written by various Parexel divisions for safety issuesReview coding of adverse events and concomitant medications for accuracy and consistencyProvide medical expertise / leadership in Proposal Development Teams for client bid pursuit meetingsProvide medical expertise to client across multiple channels and interactions such as:Consultancy on protocol development or drug development programMedical review of various documents, which might be audited by clients and regulatory agenciesProvide medical expertise and training to other Parexel colleaguesAs 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, etcSupport 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 (or Canadian equivalent) in Neurology w/ extensive experience in adult patient care, specifically neurocognitive disorders i.e. Alzheimer's. 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 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 counterpartsExcellent time management skillsExcellent verbal and written medical communication skillsExcellent standard of written and spoken EnglishA flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailWillingness to work in a matrix environment and to value the importance of teamwork.@15% domestic and/or international travel is required
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