Medical Director, Oncology

Parexel•Southport, NC

About The Position

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. During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and pharmacovigilance. Parexel has global presence in every phase of clinical research and expertise in virtually every indication and mechanism of action, including novel Immuno-oncology agents, cellular based therapy, and cancer stem cell targeted treatment. Join our growing team of Oncologists/Hematologists and make a difference in the lives of patients searching for more effective and better tolerated cancer therapies. Parexel’s continued success has positioned us for significant North American growth in the coming year. As we prepare for this expansion, we’re seeking to connect with Board-Certified Oncologists who are passionate about advancing clinical research and interested in learning more about the Medical Director role. As a 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. In addition, you will also: 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 external meetings and conferences

Requirements

Be medically qualified based on successful completion of training at an accredited medical school
Be US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
A willingness to work in a matrix environment and to value the importance of teamwork
The ability to travel 10% domestically and/or internationally as needed

Nice To Haves

Past experience as a Medical Monitor, Physician in Industry, or as a Clinical Trial Primary Investigator or Sub-Investigator is highly preferred.

Responsibilities

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
Assume the role of Senior Technical Lead in selected circumstances
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 external meetings and conferences