Jeffrey Huang Email & Phone Number

Honolulu, Hi, Us

Manhattan Beach, California, United States

Los Angeles, California, United States

Greater Los Angeles Area

Honolulu, Hi

• Responsible for developing, revising, and implementing investigator-initiated and early phase studies, which includes the drafting of protocols, informed consents, Medicare Cost Analyses (MCAs), and budgets.• Drafted the standard operating procedures (SOPs) and working practice documents (WPDs) for the development and review of investigator-initiated trials and presented SOPs to the UHCC consortium hospital sites.• Drafted Case-Report Forms (CRFs) and led the clinical research staff in operationalizing and opening studies at the UHCC consortium hospital sites.• Partnered with Regulatory to submit protocols to the Institutional Review Board (IRB) and Food and Drug Administration (FDA).• Collaborated with pharmaceutical industry medical science liaisons (MSLs) to acquire novel agents to test in the non-clinical and clinical setting, as well as propose funding for investigator-initiated trials.• Led the launch of the electronic protocol review and monitoring system (ePRMS) module of OnCore, trained the clinical research staff on its use, and presented UHCC’s readiness to Forte to implement the module consortium-wide.

White Oak, Maryland

Oncology, Office of Clinical Pharmacology• Analyzed, critiqued, and commented a wide range of oncology products submitted from the pharmaceutical industry, determining the adequacy of the protocols and resultant data from a clinical pharmacology perspective.• Prepared a comprehensive review of the submitted protocols and data and defined the conditions under which applications should be accepted or rejected.• Conveyed recommendations having a direct impact on the quality of oncology drug products reaching the U.S. consumer, as well as the direction and depth of research efforts from drug manufacturers.• Provided expertise in the areas of pharmacokinetics and drug metabolism by determining and delineating their roles in the system being reviewed. • Conducted or requested the conduct of supporting background information data on relevant clinical pharmacology, biopharmaceutics, pharmacokinetics, and analytical procedures applicable to the clinical pharmacology reviews.

Research Triangle Park, Nc

Oncology Global Business

White Oak, Md

Oncology, Office of Clinical Pharmacology

Oncology, pre-clinical and clinical drug development and research

Pharm.D., Doctor Of Pharmacy

Post-Doc Fellow, Clinical And Industrial Drug Development

Ba, Biology