Hemraj Dodiya
Principal Scientist - Toxicology (Preclinical Clinical Pharmacology) @Neurocrine Biosciences
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WORK HISTORY
Principal Scientist - Toxicology (Preclinical Clinical Pharmacology) @Neurocrine Biosciences
Develops and implements plans for preclinical testing of new and current drug candidates. • Selects and manages Toxicology and Safety Pharmacology CROs. • Oversees and leads protocol preparation for Toxicology and Safety Pharmacology studies. Manages the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports. • Performs analyses/interpretations of Toxicology/Safety Pharmacology data and participates in go/no-go decision making. • Prepares SOPs as needed to guide the Toxicology and Safety Pharmacology programs. • Authors and/or reviews Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions. • Keeps up-to-date with current regulatory guidance by attending professional meetings, trainings and/or workshops.• Works collaboratively with other scientists, technicians and colleagues as part of multidisciplinary project teams. • Performs quality control checks on non-clinical pharmacology and toxicology documents for regulatory submission. • Assists in the preparation of documents and annual investigational new drug and new drug application reports. • May provide support to build and maintain technical databases, archives and department procedures manuals. • Interact with contract research organizations (CROs), academic labs, consortia partners and/or key opinion leaders (KOLs) to finish assigned tasks in a timely manner.
EDUCATION
Rush Medical College of Rush University Medical Center
Master of Science (M.S.), Biotechnology
L.M. College of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Rush University
Doctor of Philosophy (Ph.D.), Pharmacology
SKILLS
ABOUT HEMRAJ DODIYA
Highly motivated board-certified toxicologist with 12+ years of discovery and safety assessment-related academic and industry experience in multi-disciplinary fields targeting cell and gene therapy and small molecules. A problem-solver, leader, and good communicator dedicated to ensuring rigorous science and focused on progressing programs to early GO/NO GO
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