Teams at Viking Therapeutics

Manages Phase 1–3 clinical trials from initiation through closeout, ensuring protocol, GCP, regulatory, timeline, budget, enrollment, data quality, and vendor compliance. Oversees CROs, sites, vendors, trial documentation, monitoring activities, risk resolution, and cross-functional coordination. Supports site selection, EDC and study-material development, audits, training, contracts, and clinical operational plans. Requires strong knowledge of FDA, ICH, GCP, and CFR requirements, with 10–15% travel.

Plan, coordinate, and manage ICH‑compliant drug substance and drug product stability programs across internal teams and external CROs/CMOs. Design protocols, manage sample inventory and pull schedules, trend and interpret stability data, support OOS/OOT investigations, establish shelf‑life/retest/expiry, contribute CMC/regulatory submissions, and ensure cGMP and data integrity practices.

Coordinate day-to-day clinical supply activities for trials, track GMP inventory and expiries, prepare forecasts and shipment schedules, maintain audit-ready documentation, liaise with CMOs/depots/couriers, monitor IRT/RTSM kit status and temperature-controlled shipments, and support QA, labeling, and regulatory submission materials.