Medical Director, Oncology / GI Subspecialty

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. Candidates with a subspecialty in Gastroenterology are particularly desirable for this 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

Medical Degree from an accredited institution
Board Certification / Fellowship in Oncology or equivalent training
2+ years of experience in adult or pediatric oncology
Strong interpersonal skills and the ability to collaborate effectively with sponsor and client partners
Excellent time‑management capabilities
Clear, professional verbal and written medical communication skills
A high standard of written and spoken English
Comfort working in a matrixed, team‑oriented environment
Willingness to travel up to 10% domestically and/or internationally as needed

Nice To Haves

Prior experience as a Medical Monitor, Industry Physician, Primary Investigator, or Sub-Investigator highly preferred
Candidates with a subspecialty in Gastroenterology are particularly desirable for this role.

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