Senior Director, Clin Trial Supplies

Job Title: Senior Director, Clinical Trial Supplies

Location: San Diego or Remote U.S.

Job Type: Full-Time

Avenzo Therapeutics, Inc., a clinical‑stage biotechnology company focused on developing next‑generation oncology therapies, was co‑founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand. The company is headquartered in San Diego, California and is dedicated to advancing a pipeline of targeted oncology programs that make a difference in the lives of people with cancer.

Reporting to the Senior Vice President, Clinical Operations, the Senior Director, Clinical Trial Supplies will provide strategic and operational leadership for global clinical trial supply management across Phase I‑III development. The role is responsible for end‑to‑end planning and execution of clinical supply continuity, including forecasting, inventory management, global distribution, reverse logistics, and 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 and partners.

• 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 agreements such as 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 the 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, financial tracking, and 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

• 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 chains and working CMOs in a cGMP environment
• Strong knowledge of drug development, ICH‑GCP, and applicable regulatory requirements (including 21 CFR Part 11)
• Ability to influence and lead others in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies
• Willingness and capability to work effectively in a smaller biotech company (i.e., willing to roll‑up your sleeves as necessary to help get the job done)
• Proven ability to handle a high volume of complex tasks within a given timeline
• Self‑motivated, independent and results‑oriented
• Excellent organizational and problem‑solving skills with the capacity to organize assignments, work within multiple deadlines, and change priorities
• Exceptional attention…