Director/Senior Director, Clinical Trial Supp

**Job Title:** Director/Senior Director, Clinical Trial Supplies **Location:** San Diego or Remote U.S. **Job Type:** Full-Time **Who We Are** Avenzo Therapeutics, Inc. (“**Avenzo**” or “**Company**”) is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. The Company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, Inc., respectively). Our team is passionate about and committed to advancing a pipeline of potentially differentiated targeted oncology programs that make a difference in the lives of people with cancer. The Company is headquartered in San Diego, California. **Position Summary** Reporting to the Senior Vice President, Clinical Operations, the Director/Senior Director, Clinical Trial Supplies will provide strategic and operational leadership for global clinical trial supply management across Phase I-Phase III of development. This role is responsible for the end-to-end planning and execution of clinical supply continuity, including forecasting, inventory management, global distribution and reverse logistics, ensuring uninterrupted supply in compliance with regulatory requirements. The position serves as the primary point of contact for clinical supply strategy across internal teams and external vendors/partners. **Essential Job Functions and Responsibilities** - Develop and execute global clinical supply strategies Ph I – III, including demand forecasting - and inventory optimization - Lead end-to-end clinical supply operations, including distribution, depot management, site supply and reverse logistics - Oversee vendor selection, contracting, onboarding, qualification, and ongoing operational management of external logistics partners, specialty couriers, and service providers - Manage vendor identification, selection, and contracting, in partnership with internal teams for (e.g., Master Service Agreements, Work Orders, and Change Orders) - Serve as the operational owner for day-to-day patient-specific shipment coordination, aligning constraints and QA release - Monitor supply chain performance in real-time, resolving risks such as delays, deviations, or temperature excursions - Establish efficient processes for inventory management and evaluate drug utilization versus forecast to continually enhance optimal execution of Clinical Supply strategy - Lead the development, authorship, and lifecycle management of Management, and Pharmacy Manuals - Establish and maintain SOPs, work instructions, and clinical supply documents - Collaborate cross-functionally on clinical protocols, packaging, labeling, and supply-related documentation - Manage clinical supply budgets, forecasting, and financial tracking, ~~including~~ ~~invoices~~reconciliation - Define and track clinical supplies KPIs, metrics, and operational performance to support decision-making and continuous improvement - Identify, select, and manage IRT vendors - Serve as subject matter expert (SME) during all inspections and clinical supply audits - Serve as clinical supplies key point of contact for collaborations and partnerships - Identify risks to clinical programs and develop improvement plans for clinical supply GMP **Preferred Qualifications** - Bachelor’s degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD) with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience - 8+ years of team leadership experience, with a proven track record of building effective teams and driving innovation in clinical trial optimization - Extensive experience managing clinical supply chain~~s~~ and working CMOs in a cGMP environment - Strong knowledge of drug development, ICH-GCP, and applicable regulatory requirements (including 21 CRF Part 11) - Ability to influence and lead others in preparing for audits and inspections by identifying po…