Verastem
Associate Director Clinical Supply
Needham, Massachusetts · Director
Sponsorship not specified$175k-$200kDetected 8 days ago
GCPProject ManagementForecastingBudgetingSupply ChainLogisticsInventory ManagementClinical TrialsGMPFDA RegulatoryCommunicationPublic SpeakingDemand PlanningRegulatory Affairs
About the role
- Serve as the global clinical supply representative on cross-functional study and program teams, presenting supply updates, risks, and mitigation strategies.
- Coordinate manufacturing, packaging, labeling, and release activities with CMC to ensure timely availability of clinical trial materials.
- Coordinate import/export activities and supporting documentation to enable global distribution of clinical trial materials.
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.
- Monitor global inventory levels and manage resupply strategies to minimize stockout risk while reducing excess inventory.
- 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.
- 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.
- Develop and maintain global clinical supply forecasts based on enrollment projections, dosing assumptions, protocol design, manufacturing lead times, and inventory requirements.
- Contribute to IRT supply strategies, specifications, and system requirements; perform User Acceptance Testing (UAT) and support ongoing IRT supply management.
Requirements
- 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 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.
- Experience overseeing packaging, labeling, distribution, and logistics through external CMOs and vendors, including development of clinical label text to support global regulatory requirements.
- 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.
Nice to have
- Bachelor's degree in supply chain management, life sciences, business, or a related field required
- advanced degree (e.g., MS, MBA) preferred.
Compensation
- The base salary range ($175,000 - $200,000) provided reflects our current estimate of what we anticipate paying for this position.
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