Parexel's Medical Sciences team is growing, and we currently have a fantastic opportunity for a Pulmonologist to join Parexel's highly recognized Global Medical Sciences Team! As a Medical Director you will work closely with some of the best and brightest Leaders in the Industry and assist our clients in their journeys of getting new and innovative drug treatments into the hands of those who need them most.
Overall responsibilities of the Medical Director are to:
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.
Specific responsibilities include:
- 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 (such as investigator meetings).
- Maintain up-to-date knowledge of projects by attending Professional Society Meetings.
- Provide support for Marketing activities as requested.
- Assume the role of Senior Technical Lead in selected circumstances.
- Provide medical consultation as required or requested to client/sponsor or to other Parexel divisions.
Board certificated/board eligible in Pulmonology with clinical experience is required with past related experience as a physician in Industry or as a clinical trial investigator is a plus. However, experienced Physicians and/or Medical Monitors with strong Internal Medicine qualifications coupled with strong experience in Pulmonary Medicine will also be considered.
Parexel 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.