Summary:
The Associate Director, Global Clinical Supply is responsible for developing and executing global clinical supply strategies for multiple development programs consisting of multiple Phase I, II, and III clinical studies. This role supports all aspects of clinical supply management, including investigational medicinal product (IMP) and comparator sourcing, demand forecasting, packaging and labeling, distribution, inventory management, Interactive Response Technology (IRT), vendor oversight, and budget execution.
The Associate Director serves as the Global Clinical Supply representative on cross-functional program teams and partners closely with Clinical Operations, Program Management, CMC, Regulatory Affairs, Quality, and external partners to ensure uninterrupted clinical supply throughout the lifecycle of global clinical trials. This position requires the ability to influence cross-functional teams and drive execution through collaboration. The Associate Director also serves as the operational backup to the Director of Global Clinical Supply as needed
Responsibilities:
- Develop and execute global clinical supply strategies for multiple development programs spanning Phase I-III clinical studies, translating clinical development plans into supply plans that support study timelines and program objectives.
- Serve as the global clinical supply representative on cross-functional study and program teams, presenting supply updates, risks, and mitigation strategies.
- Develop and maintain global clinical supply forecasts based on enrollment projections, dosing assumptions, protocol design, manufacturing lead times, and inventory requirements.
- Monitor global inventory levels and manage resupply strategies to minimize stockout risk while reducing excess inventory.
- Coordinate manufacturing, packaging, labeling, and release activities with CMC to ensure timely availability of clinical trial materials.
- Develop and execute sourcing strategies for IMP, commercial comparators, concomitant medications, and ancillary supplies, including global comparator procurement.
- Support lifecycle management activities including expiry extensions, relabeling, returns, reconciliation, and destruction of clinical trial materials.
- Oversee packaging, labeling, distribution, and depot activities for assigned programs, including authoring and reviewing clinical label text and packaging specifications in accordance with regulatory and quality requirements.
- Coordinate import/export activities and supporting documentation to enable global distribution of clinical trial materials.
- Contribute to IRT supply strategies, specifications, and system requirements; perform User Acceptance Testing (UAT) and support ongoing IRT supply management.
- Manage operational relationships with CMOs and Clinical Supply vendors, including regular operational reviews, review of proposals, Statements of Work, and change orders, and issue resolution.
- Partner with the Director of Global Clinical Supply to develop and manage Clinical Supply budgets, monitoring forecast versus actual expenditures and identifying financial risks.
- Contribute to the continuous improvement of Global Clinical Supply processes, SOPs, templates, and business practices.
- Serve as the operational backup to the Director of Global Clinical Supply as needed.
- Additional duties as assigned.
Qualifications:
- Bachelor's degree in supply chain management, life sciences, business, or a related field required; advanced degree (e.g., MS, MBA) preferred.
- 7+ years of clinical supply chain experience within the biotechnology or pharmaceutical industry supporting global Phase I-III clinical trials.
- Demonstrated experience with clinical supply forecasting, inventory management, and IMP/comparator sourcing.
- Experience overseeing packaging, labeling, distribution, and logistics through external CMOs and vendors, including development of clinical label text to support global regulatory requirements.
- Experience with IRT design, implementation, UAT, and clinical supply management.
- Experience supporting Clinical Supply budget planning and financial tracking.
- Working knowledge of GMP, GDP, GCP, ICH guidelines, and applicable global regulations.
- Demonstrated ability to influence cross-functional teams and external partners without direct reporting authority.
- Excellent project management, organizational, analytical, and communication skills with the ability to manage multiple priorities in a fast-paced environment.
The base salary range ($175,000 - $200,000) provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
