Vipul Gupta

WORK HISTORY

EDUCATION

ABOUT VIPUL GUPTA

Fifteen strong years of industry experience in small molecules and biologics from pre-IND to NDA with expertise in non-clinical development and clinical pharmacology.• Led non-clinical and clinical pharmacology sections writing for multiple INDs and NDAs in the field of anti-infectives, CNS, and oncology.• Participated in multiple regulatory interactions, preparation of briefing documents and responding to regulatory queries.• Managed clinical pharmacology, DMPK and bioanalytical department and mentoring of direct reports.• Managed department budget, outsourced studies (clinical pharmacology studies including bioequivalence, TQT, DDIs, human mass balance, and non-clinical studies including PK/TK, QWBA, in vitro CYPs, transporters DDI studies) with contract research organizations from CRO identification, study monitoring to regulatory submission quality reports completion.• Excellent leadership, analytical, organizational, interpersonal, challenging problem-solving skills.• Positively impacted project teams as clinical pharmacology/DMPK/bioanalytical discipline leader in outlining strategy and problem solving.• Effective communication and presentation skills: sharing perspectives with peers and management.• Expertise in non-compartmental and compartmental PK (pre-clinical and clinical), GLP TK, PK-PD data analysis, and drug-drug interaction evaluations.• Excellent writing skills with 30+ publications, a book chapter and 20 poster presentations at various national and international conferences.