Director/Senior Director, Clinical Supply Chain
Viking Therapeutics, Inc.
June 26, 2026
On-site
San Diego, CA
Operations
Responsibilities:
- Lead end-to-end clinical supply chain strategy (early development to late-stage trials) ensuring uninterrupted global supply.
- Develop demand forecasts, supply strategies, and risk mitigation plans (expiry/overage, country requirements, comparator sourcing, protocol amendments).
- Serve as primary supply chain representative across Clinical Ops, CMC, Regulatory, QA, and external partners.
- Select, qualify, and manage clinical supply vendors (CMOs, packaging/labeling partners, depots, couriers, IRT/RTSM providers) and oversee KPIs, quality expectations, continuity, and issue resolution.
- Ensure providers meet GMP/GDP and regional regulatory requirements under robust quality agreements.
- Oversee clinical labels/packaging configurations, master batch records, distribution documentation, and lot/batch/kit traceability.
- Reconcile GMP inventory and maintain visibility across CMOs/depots.
- Own global distribution strategy (temperature-controlled logistics, import/export, customs/permits) and ensure compliance with IATA/GDP/country rules.
- Investigate temperature excursions/deviations; manage IRT/RTSM configuration and change control; map kit numbers/expirations/resupply logic/depot allocation.
- Own clinical supply SOPs/work instructions/process improvements; partner with QA; support IND/CTA/NDA/MAA supply content; manage budgets/forecasts.
Requirements:
- Bachelor’s (Biology, Chemistry, Pharmacy, or related).
- 10+ years in Supply Chain/Operations/Product/CMC.
- Submission experience (IND/BLA/NDA/MAA) preferred.
- Familiarity with inventory management systems.
Skills/Knowledge:
- Pharmaceutical global logistics; FDA-regulated environments; GMP cold chain storage/shipping.
- Import/export documentation knowledge (permits/licenses/declaration letters for biologics/raw materials).
- Vendor management; ability to author/review SOPs; GMP warehouse inventory management.
- Strong troubleshooting, communication, and Microsoft Office proficiency.
Salary (if explicitly stated): $200,000–$220,000 annual salary.
- Lead end-to-end clinical supply chain strategy (early development to late-stage trials) ensuring uninterrupted global supply.
- Develop demand forecasts, supply strategies, and risk mitigation plans (expiry/overage, country requirements, comparator sourcing, protocol amendments).
- Serve as primary supply chain representative across Clinical Ops, CMC, Regulatory, QA, and external partners.
- Select, qualify, and manage clinical supply vendors (CMOs, packaging/labeling partners, depots, couriers, IRT/RTSM providers) and oversee KPIs, quality expectations, continuity, and issue resolution.
- Ensure providers meet GMP/GDP and regional regulatory requirements under robust quality agreements.
- Oversee clinical labels/packaging configurations, master batch records, distribution documentation, and lot/batch/kit traceability.
- Reconcile GMP inventory and maintain visibility across CMOs/depots.
- Own global distribution strategy (temperature-controlled logistics, import/export, customs/permits) and ensure compliance with IATA/GDP/country rules.
- Investigate temperature excursions/deviations; manage IRT/RTSM configuration and change control; map kit numbers/expirations/resupply logic/depot allocation.
- Own clinical supply SOPs/work instructions/process improvements; partner with QA; support IND/CTA/NDA/MAA supply content; manage budgets/forecasts.
Requirements:
- Bachelor’s (Biology, Chemistry, Pharmacy, or related).
- 10+ years in Supply Chain/Operations/Product/CMC.
- Submission experience (IND/BLA/NDA/MAA) preferred.
- Familiarity with inventory management systems.
Skills/Knowledge:
- Pharmaceutical global logistics; FDA-regulated environments; GMP cold chain storage/shipping.
- Import/export documentation knowledge (permits/licenses/declaration letters for biologics/raw materials).
- Vendor management; ability to author/review SOPs; GMP warehouse inventory management.
- Strong troubleshooting, communication, and Microsoft Office proficiency.
Salary (if explicitly stated): $200,000–$220,000 annual salary.