Thanh Pham

Clinical Pharmacologist @BioCryst Pharmaceuticals, Inc.

Develop clinical research documents, including clinical study synopses, protocols, CRFs, and clinical study reports, in collaboration with medical writing, clinical operations and study statisticians. • Contribute (author/and or review, as required) to regulatory documents including protocols, investigator’s brochures, briefing documents, IND applications/annual reports, responses to regulatory queries, CSRs, and Clinical Pharmacology and Biopharmaceutics Summary Documents in NDAs/MAAs. • Analysis of PK parameters for assigned studies in Phoenix WinNonlin. • Integrates clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, nonclinical ADME, and toxicology to support and impact development decisions. • Vendor management of scientific vendors, such as ECG core labs or pharmacology vendors. • Ensure validity, accuracy, relevance and completeness of medical and scientific content in clinical research and regulatory documents. • Incorporate relevant recent advances in the field into clinical research. • Provide scientific advice to the Clinical and Regulatory teams. • Plan clinical pharmacology strategy for assigned programs. • Effectively communicate clinical pharmacology concepts to diverse audiences, including rationale for study designs, and results from studies. • Participate in development of publication strategies, writing and editing of draft presentations and manuscripts. • Attend appropriate scientific meetings to maintain awareness of research activities. • Share clinical pharmacology knowledge with the organization during continuing education sessions and CRA and vendor trainings, at an adapted level of understanding.