Director, Supply Chain
San Diego, CA - USA
Job Summary
Clinical Supply Strategy & Planning
- Develop and execute global clinical supply strategies across Phase 1Phase 3 clinical development programs.
- Translate clinical protocols and enrollment assumptions into supply forecasts and operational supply plans.
- Design supply strategies for complex trials including multi-arm studies global trials and physician-choice arms.
- Develop integrated supply plans covering manufacturing packaging labeling distribution and resupply.
- Perform supply risk assessments and scenario planning to mitigate supply interruptions.
- Lead demand forecasting and supply modeling using appropriate planning tools and simulation approaches.
- Provide clinical supply input during protocol development and study feasibility discussions.
Clinical Trial Materials Management
- Oversee the end-to-end lifecycle of clinical trial materials from production through distribution and reconciliation.
- Manage investigational product supply including lot tracking expiry management and retest date monitoring.
- Ensure timely packaging labeling and release of clinical trial materials.
- Track clinical inventory across manufacturing sites depots and clinical sites.
- Ensure proper documentation and traceability of all clinical trial materials.
- Oversee drug returns destruction and final study reconciliation activities.
Vendor & External Partner Management
- Serve as the business owner for key clinical supply vendors including:
- Clinical packaging and labeling providers
- Clinical depots and 3PL providers
- Comparator sourcing vendors
- RTSM / IRT system providers
- Clinical manufacturing and distribution partners
- Lead vendor selection contracting and onboarding processes.
- Manage Master Service Agreements (MSAs) Statements of Work (SOWs) and change orders in collaboration with Legal and Finance.
- Establish vendor performance metrics and conduct regular business reviews.
- Ensure vendors operate in compliance with GxP requirements and study timelines.
Clinical Depot & Global Distribution Management
- Lead selection and oversight of global clinical depots and distribution partners.
- Develop depot strategies to ensure efficient global supply distribution.
- Ensure appropriate temperature-controlled logistics and chain-of-custody controls.
- Oversee import/export processes and country-specific regulatory requirements for IMP distribution.
- Manage depot inventory levels to ensure site readiness and prevent supply shortages.
Comparator & Ancillary Supply Strategy
- Develop strategies for sourcing comparator drugs required for clinical trials.
- Manage procurement of commercially available reference products when manufacturer supply agreements are unavailable.
- Oversee procurement and management of ancillary supplies required for clinical trials.
- Ensure full regulatory compliance traceability and documentation of comparator and ancillary products.
IRT / Clinical Supply Systems
- Partner with Clinical Operations to design and implement IRT/RTSM systems supporting randomization and supply management.
- Define resupply algorithms including site buffer levels demand assumptions and resupply triggers.
- Monitor ongoing supply performance using system-generated data and analytics.
- Ensure alignment between randomization strategies and supply distribution.
Inventory Management & Drug Accountability
- Establish processes for clinical inventory tracking across manufacturing depots and sites.
- Ensure accurate investigational product accountability.
- Monitor inventory health including expiry management and wastage mitigation.
- Oversee reconciliation of clinical supplies at study closeout.
Regulatory Compliance & Quality Oversight
- Ensure clinical supply activities comply with applicable global regulations including GCP GMP and GDP.
- Support regulatory submissions requiring clinical supply documentation.
- Partner with Quality to support inspections audits deviation investigations and CAPA management.
- Maintain SOPs and documentation governing clinical supply operations.
Cross-Functional Leadership
- Serve as the clinical supply representative on global clinical program teams.
- Collaborate with:
- Clinical Operations
- CMC / Manufacturing
- Quality Assurance
- Regulatory Affairs
- Finance and Procurement
- Provide leadership and supply expertise to support clinical development strategy.
Budget & Financial Management
- Develop and manage clinical supply budgets including packaging depot operations comparator procurement and logistics.
- Track supply chain spending against study budgets and forecasts.
- Provide leadership with supply cost projections and scenario analyses to support decision making.
Qualifications :
- Minimum 15 years of supply chain experience in the pharmaceutical industry preferred.
- Bachelors or masters degree with 12 years of relevant global supply chain management experience in the pharmaceutical industry a plus.
- Deep experience in global late phase clinical supply is preferred.
- Strong understanding of regulatory and technical influences and ability to assess business and financial implications of decisions
- In-depth technical operations and quality knowledge as well as applied expertise in GMP and GDP regulated facilities
- Experience managing external suppliers such as Clinical Depots 3PL and Logistics providers
- Certified Supply Chain Professional (CSCP) certification a plus.
Additional Information :
The anticipated salary range for candidates is between $200000-$220000 in San Diego. The final rate offered to a successful candidate will be dependent on several factors that may include but are not limited to the title type and length of experience within the job type and length of experience within the industry education etc.
ORIC Pharmaceuticals Inc. is an equal opportunity employer. ORIC does not discriminate based on race color religion gender sexual orientation gender identity age national origin disability status protected veteran status or any other legally protected characteristic.
Remote Work :
No
Employment Type :
Full-time
About Company
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more