Director/Senior Director, Clinical Trial Supp
About The Position
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. 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.
Requirements
- 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 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
Nice To Haves
- International clinical supply experience preferred
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
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Basic life and AD&D insurance
- Short-term disability insurance
- Long-term disability insurance
- Flexible spending accounts
- Health savings accounts
- Voluntary insurance programs (voluntary life, AD&D accident, and critical illness)
- 401(k) plan
- 10 hours of paid vacation time accrued every month
- 1 hour of paid sick leave accrued for every 30 hours worked
- 17 paid holidays each calendar year, including a winter closure
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What This Job Offers
Job Type
Full-time
Career Level
Senior
