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Associate/Medical Director

3 months ago

Southeast Fairbanks, United States Parexel Full time

Parexel is known for our unparalleled expertise in Dermatology

Over the past five years Parexel has provided clinical research services for ~100 dermatology studies, enrolling more than 20,000 patients at ~5,000 hospitals and clinics worldwide. We play an integral role in bringing new treatment options to millions of patients globally In fact, as one example, we conducted clinical trials including pivotal program resulting in global approvals of one of the leading biologics for treatment of moderate to severe Atopic Dermatitis. The impact of our team is profound

We currently have an exceptional opportunity on our Medical and Sciences team for a Dermatologist to bring their experience to Parexel

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:

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 or Canadian Board-certified in Dermatology. 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 #LI-REMOTE