Responsibilities:
- Responsible for end-to-end execution of clinical supply activities including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout
- Ensure protocol milestones are met on time and in full (e.g., FPI, SIV readiness, on-time delivery to sites/patients)
- Partner cross-functionally with Clinical Operations, QA, Regulatory, and CMOs to ensure efficient and compliant execution
- Manage and escalate day-to-day execution risks including delays, deviations, and supply disruptions with clear escalation and mitigation
- Oversee temperature excursions and supply deviations ensuring appropriate documentation and resolution
- Ensure execution activities are compliant, well-documented, and inspection-ready
- Maintain visibility to inventory levels and supply availability across programs
- Contribute to continuous improvement of execution processes, tools, and ways of working
- Train fellow trial leads
Qualifications:
- B.Sc. in a scientific field or Supply Chain Management or related field
- 5+ years of direct Clinical Supply Chain experience globally
- Demonstrated knowledge of clinical supply chain packaging, labeling, inventory management, global distribution
- Strong understanding of clinical trial operations and drug development lifecycle
- Foundational knowledge of GMP/GxP/GCP and global regulatory requirements (FDA, EU, etc.)
- Experience with systems/tools (IRT/IXRS, inventory systems, Excel, Smartsheet, ERP)
- Risk identification, assessment, and mitigation
- Project management across multiple studies/programs
- Vendor/CMO/CRO management and oversight
- Budget tracking, cost control, and financial oversight of protocols
- Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc.)
- Excellent communication, attention to detail, collaboration, ability to manage complex challenges, and influencing skills
Benefits:
- Comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, lifestyle reimbursement, flexible spending/health savings accounts, and 401(k) with company match; paid time off, wellness days, holidays, and two recharge breaks.