Associate Director, Clinical Supply Chain

Non-Solicitation Policy And Notice To Agencies And Recruiters IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to humanresources@ideayabio.com. We ask that you only email your interest once. Job Summary Job Description What You’ll Do Clinical Supply Management (General): Assist with identification and management of external global partners (e.g., depots, couriers, CMOs, IRT vendors) to ensure availability of drug supply at depots/clinical trial sites. Lead and assist with developing, maintaining, and implementing supply chain policies, procedures, systems and techniques with a focus on continuous improvements. As requested, assist with the preparation of the departmental budget, collaborate with Finance to address budget and invoice inquiries Create and/or revise study specific Pharmacy Manuals and supply related training/instructional materials (i.e., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.) based on protocol requirements. Ensure appropriate documentation of IP supply activities is filed for the Trial Master File Participate in relevant team meetings providing clinical supply status and support Manage supply planning/demand forecasting to ensure alignment with study activity and timelines Monitor inventory levels at clinical sites and depots throughout the life of a trial taking preventative actions to avoid potential supply issues; management may be manual or automated depending on study phase and complexity Establish and document a supply plan for each project as applicable. Assist with procurement and management of commercially sourced supplies Follow-up and resolve Temperature Excursions and/or Product Complaints from sites/depots Ensure expiry extensions are provided to depot/sites as needed to support continued use Collaborate with study team and vendors to assure proper distribution of clinical supplies to study sites Manage return and destruction of clinical supplies, with proper documentation of all steps. Collaborate with the CMC and clinical team in developing CTM supply requirements planning based on forecasts provided by Clinical Operations Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice Support QA with timely review and approval of batch records for packaging and labeling of study drug Vendor Management/Oversight Serve as point of contact for third party packaging, labeling, distribution, storage Vendors, and CRO for assigned projects representing Clinical Supply Chain Serve as the point of contact for study specific IRT URS, UAT and enhancements in support of clinical supply management Packaging and Labeling Preparation of label text, coordination of label translations and proofs that align with county specific regulatory requirements Review of pre and post executed labeling batch records Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (e.g., QP Release, Certificates of Analysis/Compliance, Country specific CTM release) Coordinate expiry date extensions and re-labeling operations, when applicable Oversee maintenance of appropriate quantity of retain samples IRT (Interactive Response Technology) Systems Work with cross-functional teams to develop study-spe…

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