New York City Metropolitan Area
Oncology Early Stage Development
Early Clinical Development - Oncology
Prostate cancer and Neuroendocrine tumors
REGULATORY AFFAIRS • Provide global regulatory support in ongoing exploratory clinical trial • Support Regulatory Directors, Leads, and Managers in regulatory deliverables for Phase I-III studies, including Pre-IND planning, IND planning and submission, DSUR, and briefing documents for meetings with regulatory agencies • Attend cross-functional team meetings for Phase I-III projects and support Sr. Regulatory Director in global regulatory strategic planning, research, and operational deliverables for early and late stage developments across multiple therapeutic areas • Support preparation of upcoming FDA Advisory Committees Meeting in Respiratory • Provide clinical and regulatory intelligence for US- and UK-based colleagues, including review of timeline of supplemental approvals in the US and EU • Evaluate clinical safety signal and profiles in anticipation of regulatory issues CLINICAL • Provide clinical and regulatory support for Ethics submission package, including protocol, IB, ICF, and participant instructions • Review clinical safety signals and subject profiles with Safety Review Team (SRT) across various projects • Author clinical study report (CSR) and prepare package for regulatory submission, along with CTR updates
Developed and led subject recruitment and enrollment for several large, multicenter phase 3 studies, resulting in top 3 enrollment status among all study sites • Developed and led effective subject recruitment strategies, including eligibility criteria worksheets, decision tree flowchart for multiple acute heart failure (AHF) trials, and subject enrollment SOPs • Supported IRB submissions and IDS Pharmacy contracts, maintained source document binders, resolved eCRF queries, and coordinated site initiation and monitoring visits • Interacted directly with IDS pharmacists, including contracting and discussion of investigational drug preparation and work flow • Developed sequential worksheets for eCRFs data entry and Source document triggers, which were adapted by sponsor site monitor for the Clinical Development Team for use at other US sites • Generated recruitment summaries and analysis, submitted regular screening logs to Sponsors while adhering to cGCPs and HIPPA • Developed Dear Physician letters and nursing in-service documents for clinical trials • Trained new clinical trial coordinators and research associates in clinical trial recruitment and coordination, and lab sample processing while adhering to cGMPs Additional research experience: • Evaluated utility of biomarkers in heart failure • Authored manuscripts, supported peer-reviewed publications, reviewed manuscripts and abstracts for publications and conferences in heart failure • Trained in EPIC