Director, Clinical Supply Chain

Role Summary

Director, Clinical Drug Supply responsible for managing the timely provision of clinical trial material (CTM) across IDEAYA programs, overseeing vendor relationships, ensuring global regulatory compliance, and driving efficient processes to support global clinical trials. Leads a team of clinical supply chain professionals, aligns cross-functionally, and translates clinical development needs into actionable supply strategies. Position based in South San Francisco and onsite four days per week.

Responsibilities

• Manage a team of Clinical Supply Chain professionals to ensure continuous CTM supply for all IDEAYA clinical programs.
• Implement a Clinical S&OP process with Supply Chain Leadership to align CTM requirements organization-wide.
• Proactively manage study forecasts and inventory across depots and sites to prevent shortages or overages.
• Develop sourcing strategies for commercial comparator or adjunctive supplies ensuring timely and cost-effective delivery.
• Develop Inventory Management processes for compliant and timely reporting of global clinical inventory levels.
• Interpret clinical trial protocols for study supply requirements and identify risks with mitigation strategies.
• Develop study-specific Pharmacy Manuals and supply-related training materials.
• Document Investigational Product (IP) supply activities for the Trial Master File.
• Participate in team meetings providing clinical supply status reports and support.
• Establish and document the Supply Chain for each project as applicable to scope.
• Handle temperature excursion investigations, product complaints, expiry management, and re-labeling as needed.
• Ensure expiry extensions are provided to depots/sites to support continued use.
• Collaborate with study teams and vendors to ensure proper distribution of clinical supplies to study sites.
• Manage return and destruction of clinical supplies with proper documentation.
• Provide documentation for global shipment of clinical supplies (proformas, customs docs, invoices).
• Develop strong working relationships with QA and Regulatory for timely review/approval of batch records.
• Serve as primary contact for clinical packaging, labeling, distribution, and storage vendors; lead vendor governance and performance tracking.
• Lead vendor selection, RFPs, SOWs, service agreements; ensure alignment with budget and scope.
• Review and approve vendor invoices and change orders; ensure cost efficiency and compliance.
• Design/review/approve investigational supply label text, packaging configurations, and regulatory-compliant requirements.
• Plan and coordinate vendor activities for production of labels and packaging; manage releases and regulatory documentation.
• Plan for expiry extensions, re-labeling campaigns, and maintain retain samples appropriately.
• Work with cross-functional teams to develop IRT specifications; perform UAT and monitor IRT inventory and functionality.
• Post-IRT deployment, manage system updates for inventory and resupply processes; act as escalation point for site issues.

Qualifications

• Bachelor’s Degree or higher in health or life sciences.
• 10+ years’ experience in pharmaceutical/biotech industry performing international clinical drug supply logistics/management.
• Experience across global, multi-site clinical studies at all phases (I–III), including NDA preparation.
• Experience interpreting clinical study protocols and forecasting clinical supply plans/forecasts.
• Strong knowledge of GMP, GCP, ICH guidelines, and regulatory expectations.
• Experience with Interactive Voice/Web Response System (IRT) design, implementation, testing, and monitoring.
• Proven ability to work with CMOs, manage external partnerships, and adapt to evolving program priorities.
• Strong communication skills with the ability to influence internal stakeholders and external vendors.
• Organized, detail-oriented, with strategic planning and tactical execution capabilities.
• Collaborative, integrity-driven, committed to quality, and able to think critically in a fast-paced environment.
• Proficiency in Microsoft Office; experience with SharePoint/Box and inventory systems.
• Willingness and ability to travel domestically and internationally as needed.

Education

• Bachelor’s Degree or higher in health or life sciences.

Additional Requirements

• Willingness and ability to travel domestically and internationally as needed.
• Onsite presence required four days per week at South San Francisco headquarters.