Teams at Braeburn

Lead development and maintenance of the Clinical Quality Management System ensuring GCP compliance; oversee CRO and vendor audits, manage CAPAs and deviations, maintain inspection readiness, implement risk mitigation, and deliver QA training and metrics for clinical operations.

Manage key accounts in Columbus territory to educate HCPs on Braeburn products, ensure patient access, resolve reimbursement issues, meet sales targets, collaborate cross-functionally, and maintain compliance with company policies and REMS requirements.

Lead and execute statistical analyses for clinical trials and RWE, author SAPs and statistical methods, review SDTM/ADaM and TLFs, perform QC, support regulatory submissions, collaborate with CROs and external partners, and improve biostatistics processes.