Jobs at Viking Therapeutics

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.

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 internal technical strategy for medical device and drug-device combination product development from early development through pre-commercial readiness. Establish design controls, risk management, human factors, verification/validation, and DHF. Manage external suppliers/CMOs, author regulatory device sections, define specifications and control strategies, and coordinate cross-functional teams to deliver phase-appropriate combination product activities on time and compliant with regulations.

Manage clinical data management activities for assigned studies, oversee CRO data management, design CRFs and EDC/IRT/ePRO systems, develop data review strategies and DMPs, ensure timely data transfers and database lock, maintain regulatory and GxP/CDISC/21 CFR Part 11 compliance, and collaborate with cross-functional teams and vendors.

Support clinical data management for assigned studies: review and maintain data documentation, assist CRF/CCG design, test and maintain EDC/IRT/ePRO systems, perform data checks and query review, prepare listings and metrics, reconcile data transfers, track issues, and ensure regulatory and GxP compliance.

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.

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.