Teams 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.