Jobs at Viking Therapeutics

Lead and support Veeva eQMS implementations and ongoing administration across QualityDocs, QMS, Training and related modules. Configure workflows, map processes (Document Management, Change Control, Deviations, CAPA, Training), migrate documents, develop training, support enhancements, maintain release impacts, and assist audit and regulatory readiness in a GMP-regulated environment.

Lead clinical pharmacology and PK/PD activities across preclinical and early clinical programs. Design and execute PK, PK/PD, and exposure-response analyses, oversee bioanalysis and regulatory deliverables, support population PK and modeling, and guide dose selection and study design.

Lead nonclinical in vitro and in vivo pharmacology and toxicology strategies for metabolic and obesity programs. Design, oversee, and interpret GLP and non-GLP toxicology, safety pharmacology, and reproductive studies. Manage CRO relationships, integrate PK/TK, pathology, and biomarker data to support candidate selection and IND submissions. Support regulatory filings, dose selection, risk assessment, mentor junior scientists, and guide strategic program planning.

Lead Quality Systems for clinical and commercial operations, advancing QMS and eQMS (Veeva), driving inspection readiness, audit/CAPA management, QRM, regulatory support for CMC and submissions, cross-functional partnership, and mentoring QA staff to ensure GMP and FDA compliance.

Manage operational planning and CRO/vendor activities for Phase 1-3 clinical trials, ensuring adherence to protocols, GCP, SOPs and regulations; oversee site selection, monitoring, data collection, budgets, documentation, and risk mitigation; coordinate cross-functional teams and trial close-out.