Jamie C B.

Background

About Jamie C B.

I am a Director of Medical Affairs with 22 years of experience managing Phase I-IV clinical trials. I have served as Department Head for over a decade, building the Clinical Data Management department from scratch for Warner Chilcott, now part of Allergan. Taking advantage of my strong medical background, I transitioned to clinical science as a safety data reviewer at the compound level and eventually moving to my current position as Director of Medical Affairs. My experience includes full clinical operation functions, medical coding, safety review, ePRO execution, SAE reconciliation and review, system validation and participation in 5 FDA audits. I also have over 15 years of global trial and CRO management experience, including participation in over 10 vendor audits. Therapeutic Areas: • Oncology: Lymphoma, Melanoma, HER2-positive breast cancer, Small cell lung cancer, Ovarian cancer, and Cervical cancer • Infectious Disease: Urinary Tract Infections, and COVID-19 • Women’s Health: Hormone replacement therapy • CNS: Major Depressive Disorder, and Pain management • Dermatology: Atopic dermatitis, Acne, Psoriasis, Vitiligo, • Medical Device: Ureteral stent