Director, Clinical Supply Chain

IDEAYA Biosciences is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small‑molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first‑in‑class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody‑drug conjugates, or ADCs, for molecularly defined solid tumor indications.

Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Location:

South San Francisco, CA.

We are seeking an experienced, strategic, resourceful, and highly motivated Director, Clinical Drug Supply. This role requires a leader able to operate effectively in a fast‑paced and evolving environment, engage cross‑functionally across departments, and communicate clearly and proactively across internal and external stakeholders. The ideal candidate will collaborate across teams, think critically, and manage complex drug supply chains while translating clinical development needs into actionable supply strategies.

The Director will manage a team responsible for the timely provision of clinical trial material (CTM) for all IDEAYA programs and oversee vendor relationships, ensure compliance with global regulatory standards, and champion efficient processes to support the successful execution of global clinical trials.

• Manage a team of Clinical Supply Chain professionals to ensure that all IDEAYA clinical programs are continuously supplied with CTM.
• Working with Supply Chain Leadership, implement a Clinical S&OP Process to ensure organization wide alignment on the 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 (i.e., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.).
• Ensure appropriate documentation of Investigational Product (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.

• 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…