Director, Clinical Supply Chain

Role Summary

Director, Clinical Drug Supply. We are seeking an experienced, strategic, resourceful, and highly motivated leader to manage complex clinical drug supply chains, oversee vendor relationships, ensure regulatory compliance, and drive efficient processes to support global clinical trials. This role requires cross-functional collaboration, clear communication with internal and external stakeholders, and the ability to operate autonomously in a fast-paced environment. Onsite four days per week at the South San Francisco headquarters.

Responsibilities

• Manage a team of Clinical Supply Chain professionals to ensure that all IDEAYA clinical programs are continuously supplied with CTM.
• Implement a Clinical S&OP Process to ensure organization-wide alignment on CTM requirements.
• Proactively manage study supply forecasts and inventory levels across depots and sites to prevent shortages or overages.
• Develop sourcing strategies for commercial comparator or adjunctive supplies, ensuring timely and cost-effective delivery to support all IDEAYA clinical programs.
• Develop Inventory Management process to ensure compliant and timely reporting of global clinical inventory levels.
• Interpret and advise on clinical trial protocols for study supply requirements and identify risks and develop mitigation strategies.
• Develop study-specific Pharmacy Manuals and supply-related training/instructional materials (e.g., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.).
• Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Participate in relevant 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 depot/sites as needed to support continued use.
• Collaborate with study team and vendors to ensure proper distribution of clinical supplies to study sites.
• Manage return and destruction of clinical supplies, with proper documentation of all steps.
• Provide documentation for global shipment of clinical supplies, e.g., proformas, customs documentation, and commercial invoices.
• Develop excellent working relationships with QA and Regulatory for timely review and approval of batch records for packaging and labeling of study drug.

Vendor Management/Oversight

• Serve as the primary point of contact for clinical packaging, labeling, distribution, and storage vendors.
• Develop a governance process for effective management of these vendors.
• Track performance, escalate issues, and ensure alignment with quality and regulatory expectations.
• Lead vendor selection, RFPs, SOWs, and service agreements; ensure alignment with budget and scope.
• Review and approve vendor invoices and change orders; ensure cost efficiency and compliance.

Clinical Packaging and Labeling

• Design/review/approve investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements.
• Develop/review/approve clinical supply packaging configurations and specifications.
• Plan and coordinate vendor activities for production of labels and packaging of clinical supplies.
• Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.). Plan for and manage expiry extensions, re-labeling campaigns, and ensure retain samples are maintained appropriately.

IRT (Interactive Response Technology) Systems

• Work with cross-functional teams to develop study-specific IRT specifications and requirements.
• Perform user acceptance testing (UAT).
• Perform unblinded monitoring of IRT inventory at depots/sites with respect to recruitment.
• Perform unblinded IRT functionality monitoring to ensure resupply generation, etc. occur within defined specifications.
• Post IRT deployment, manage system updates for supply expiration date extensions, addition of new depot inventory, generation of manual re-supply shipments, evaluation of temperature excursions, etc.
• Serve as an escalation point for supply-related issues received from sites.

Requirements

• Bachelor‚Äôs Degree or higher in health or life sciences.
• 10+ years‚Äô experience in the pharmaceutical/biotechnology industry performing international clinical drug supply logistics/management.
• Proven success working across global, multi-site clinical studies at all phases (I‚ÄìIII), including NDA preparation.
• Experience interpreting clinical study protocols and developing well-planned, accurately forecasted clinical supply plans/forecasts.
• Strong working knowledge of GMP, GCP, ICH guidelines, and regional/global regulatory expectations.
• Experience with Interactive Voice/Web Response System (IRT) design, implementation, user testing and monitoring.
• Demonstrated success working with CMOs, managing external partnerships, and navigating evolving program priorities.
• Strong communication skills with the ability to influence internal stakeholders and external vendors.
• Organized, detail-oriented, and capable of strategic planning and tactical execution.
• The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment.
• Proficiency in Microsoft Office Suite and experience with collaborative platforms (e.g., SharePoint, Box) and inventory systems.
• Willingness and ability to travel domestically and internationally as needed.