Associate / Medical Director, Clinical Neurosciences

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 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 i