Associate Director, Clinical Supply Chain

About the role

IDEAYA 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. When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com. Location: South San Francisco, CA. Position Summary: IDEAYA is seeking an Associate Director of Clinical Supply Chain. The role of Associate Director is responsible for providing execution support for all aspects of clinical trial materials (CTM) for all clinical trials of IDEAYA programs. This position will provide support to the leadership of Clinical Supply Chain in the planning, forecasting, material sourcing, packaging and labeling, distribution, return and destruction of IDEAYA investigational drugs. The essential responsibilities of Associate Director include (but not limited to) clinical trial supply management, vendor management, oversight of external partners including depots and Contract packaging Organizations to ensure robust and compliant supply chain for all IDEAYA’s programs and in accordance with applicable laws and regulations. This role requires close coordination and collaboration with stakeholders across multiple functional areas within IDEAYA including CMC, QA, QC, Clin Dev/Clin Ops, Regulatory, and Program Management. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy. Reporting to: Director, Clinical Supply Chain.

Responsibilities

• 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.
• 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.
• 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.
• Work with cross-functional teams to develop study-specific IRT specifications and requirements from a Clinical Supply perspective.
• Perform user acceptance testing (UAT