Manager, Clinical Supply

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the comprehensive clinical supply planning and implementation for designated clinical programs.

• Formulate and uphold clinical supply strategies that encompass forecasting, inventory management, manufacturing, packaging, distribution, and contingency measures.

• Take ownership of clinical supply tasks, ensuring that deliverables, milestones, and commitments are met punctually.

• Recognize, communicate, and alleviate supply chain risks that may impact study schedules, product availability, regulatory compliance, or operational efficiency.

• Collaborate with Clinical Operations, Quality Assurance, Regulatory Affairs, Finance, contract manufacturers, packaging suppliers, depots, and distribution partners.

• Supervise contract manufacturers, vendors, and logistics providers; foster issue resolution, accountability, and continuous enhancement.

• Provide updates on stakeholder status, escalate issues as necessary, and manage reporting for effective oversight.

• Handle both domestic and international clinical supply logistics and distribution, ensuring adherence to regulatory and quality standards.

• Assist in budgeting, forecasting, inventory optimization, and strategic planning processes.

• Contribute to Quality System activities, including change controls, investigations, documentation, inspections, and continuous improvement initiatives.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, Supply Chain, Engineering, Business, or a related field, or an equivalent combination of education and experience.

• At least five (5) years of experience in clinical supply chain, pharmaceutical manufacturing, CMC operations, or related pharmaceutical functions.

• Proven experience in developing and implementing clinical supply strategies, which include forecasting, inventory management, manufacturing planning, packaging, distribution, and vendor oversight.

• Strong understanding of pharmaceutical manufacturing, clinical supply chain operations, cGMP regulations, GDP principles, and relevant regulatory standards.

• Demonstrated capability to independently manage multiple intricate projects, drive the execution of deliverables, and maintain accountability for outcomes in a dynamic environment.

• Proven ability to proactively identify risks, devise mitigation strategies, and effectively communicate and escalate issues to stakeholders and management.

• Exceptional communication, stakeholder management, and cross-functional leadership abilities.

• Experience overseeing clinical supply operations for global Phase II and Phase III clinical trials.

• Background in a small or emerging biotechnology company setting.

• Experience managing external contract manufacturers, packaging vendors, depots, IRT providers, and global logistics partners.

• Familiarity with IRT/RTSM platforms, inventory management systems, serialization technologies, and clinical trial logistics processes.

• Proficient in utilizing digital tools, data analytics, automation, and artificial intelligence solutions.

• PMP, APICS/ASCM, Supply Chain, or related professional certification is preferred.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holidays.

• Opportunities for professional development and continuing education.

• Collaborative and innovative work environment.