[Remote] Senior Director, Clin Trial Supplies

Note: The job is a remote job and is open to candidates in USA. Avenzo Therapeutics is a clinical-stage biotechnology company developing oncology therapies. The Senior Director will lead global clinical trial supply strategy and operations across Phase I–III, ensuring supply continuity and regulatory compliance while coordinating internal teams and external vendors.

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, 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

Skills

• Bachelor's degree required
• 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 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 to detail
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset
• Advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD)
• International clinical supply experience preferred

Benefits

• Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance.
• Short-term and long-term disability insurance
• Flexible spending accounts
• Health savings accounts
• Voluntary insurance programs, including voluntary life, AD&D accident, and critical illness
• Employees will also be able to enroll in the Company’s 401(k) plan.
• Employees will accrue 10 hours of paid vacation time every month
• Accrue 1 hour of paid sick leave for every 30 hours worked
• 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies
• The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.
• Remote: Home office; expected to travel to and work from the Company’s headquarters in San Diego from time to time
• San Diego-based: On-site requirement (Monday through Thursday)

Company Overview