Associate Director, CMC Clinical Drug Supply & Logistics

Role Summary

Associate Director, Clinical Drug Supply & Logistics located in South San Francisco. Collaborates with cross-functional teams to support the drug development pipeline and ensure timely, compliant management of clinical supply chains. Onsite four days per week according to company policy.

Responsibilities

• Manage investigational product supply planning/forecasting for multiple domestic and global clinical trials to ensure alignment with study activity and timelines
• Collaborate with the CMC and clinical team in developing CTM supply requirements planning based on forecasts
• Participate in relevant team meetings providing clinical supply status reports and support
• Establish and document the supply chain for each project as applicable to the scope
• Vendor Management/Oversight as a point of contact for third-party packaging, distribution, and storage Vendors
• IRT (Interactive Response Technology) Systems, design, review specifications, build, perform user acceptance testing (UAT), deployment, maintain, monitor, enhance systems
• Preparation of label text, translations, and proofs that align with country requirements, review of executed labeling batch records, overseeing release
• Liaise with QA and other appropriate parties to ensure timely review and approval of batch records for packaging and labeling per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.)
• Collaborate with the study team and vendors to ensure proper distribution of clinical supplies to study sites
• Revise study specific Pharmacy Manuals and supply-related training/instructional materials based on protocol amendments
• Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid potential supply issues
• Follow-up on reported Temperature Excursions and/or Product Complaints from sites/depots
• Ensure expiry extensions are provided to depot/sites as needed to support continued use
• Serve as an escalation point for supply-related issues received from sites
• Provide and/or support documentation for global shipment of clinical supplies, e.g., proformas and commercial invoice
• Filing appropriate documentation for IP supply activities in the Trial Master File
• Manage return and destruction of clinical supplies, with proper documentation of all steps
• Ensure activities are performed on time and with good quality, in compliance with Regulatory Authorities‚Äô regulations / guidelines and IDEAYA‚Äôs policies

Qualifications

• Required: BS/BA in Supply Chain Management, or related field; equivalent combination of education and experience considered
• Required: Minimum 7 years of clinical drug supply management experience with increasing responsibility
• Required: Experience in leading cross-functional groups; late phase and commercial experience a plus
• Required: Expert knowledge of GXP requirements and industry service providers, trends, and challenges
• Required: Strong understanding of regulatory requirements impacting the clinical drug supply chain
• Required: Analytical skills to forecast and manage supply chain risks and inventory
• Required: Knowledge and application of building and enhancing IRT systems
• Required: Experience with global comparator sourcing
• Required: Knowledge of trade compliance and VAT reclamation
• Required: Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
• Required: Experience in managing international CMOs, reviewing documentation, and ensuring proper guidelines are followed
• Required: Exceptional problem-solving skills and ability to adapt quickly

Skills

• Supply chain forecasting and planning
• CDMOs and global vendor management
• IRT system development and maintenance
• Regulatory compliance and GMP/GXP knowledge
• Pharmacy manual development and training material creation
• Inventory management and risk assessment
• Documentation and Trial Master File remediation

Education

• BS/BA in Supply Chain Management or related field (or equivalent experience)

Additional Requirements

• Onsite work four days per week at South San Francisco headquarters