Senior Manager, Clinical Supply Chain

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

📋 Description

• Oversee the complete Clinical Supply Chain processes, which encompass planning, packaging and labeling, distribution, returns, and destruction for designated clinical programs.

• Create and manage supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC teams.

• Supervise Investigational Product inventory levels at depots and clinical sites.

• Organize the movement of inventory from manufacturers to depots or clinical locations.

• Design and/or evaluate label text to ensure it meets product specifications and complies with regulatory standards.

• Administer Investigational Product in alignment with study timelines, clinical protocols, cGMP, GCP, ICH, FDA, and relevant regulations.

• Work together with Clinical Operations, CMC, Regulatory Affairs, QA, PDM, external partners, and CMOs.

• Manage clinical supply and logistics while addressing shipment delays, temperature deviations, and import/export challenges.

• Handle clinical trial contracts, purchase orders, invoices, and budgets for clinical supply vendors.

• Engage in budget and forecasting planning for the Clinical Supply Chain.

• Represent the Clinical Supply Chain during clinical trial meetings.

• Convey plans and timelines to both internal and external customers and partners.

⛳️ Requirements

• A BS/BA degree in life sciences or business, or an equivalent qualification is required.

• A Master’s degree in life sciences or business is preferred.

• A minimum of 5–7 years of relevant experience in the life sciences industry, including project management, pharmaceutical development, clinical supply management, and/or clinical trials coordination.

• At least 3+ years of experience in Clinical Supplies Management.

• Strong proficiency in Microsoft Excel, PowerPoint, and Project software.

• APICS certification (CPIM, CLTD, CSCP) is preferred.

• A solid understanding of clinical study design, including randomized, blinded, and open-label studies, as well as study execution.

• Familiarity with cGMP, GCP, ICH, FDA, and applicable international, federal, and local regulations.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Retirement savings plan with company match.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.