Manager – Clinical Supplies

• Develop study-specific Investigational Product Supply Plans
• Contribute to Pharmacy Manuals and supply-related training/instructional materials
• Manage supply planning and forecasting to align with study activity and timelines
• Perform supply accountability tracking and maintain Master, Pharmacy and Subject logs
• Ensure investigational product supply activities are documented in the Trial Master File
• Monitor site inventory levels throughout trials and proactively avoid supply issues
• Collaborate with study teams and external vendors to distribute supplies to clinical sites
• Coordinate procurement, temperature excursions and product complaints
• Ensure expiry extensions are performed at depots and sites as needed
• Manage clinical supply returns and destruction with complete documentation
• Serve as primary contact for third-party packaging, distribution and storage vendors
• Manage vendor RFIs, quotes and work orders; assist with budgets and quarterly budget tracking
• Design, review and coordinate approval of investigational supply label text and proofs
• Ensure labels meet country-language, translation and regulatory requirements
• Liaise with internal and external parties to obtain clinical study supply releases
• Work with Clinical Operations to develop study-specific IxRS specifications and requirements
• Perform unblinded monitoring of IxRS/depot inventory and resupply order generation
• Prepare KPI reports, perform root-cause analysis and implement continuous improvement actions
• Participate in annual business review meetings with packaging and labeling vendors
• Follow company policies and ensure direct reports, if any, understand and follow them
• Perform other duties as assigned

• A university degree in health sciences, life sciences or physical sciences (or equivalent)
• Minimum of 7+ years’ experience in the pharmaceutical/biotechnology industry
• Minimum of 5+ years of international clinical supply experience
• Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Distribution Practices (GDP), International Conference on Harmonization (ICH) Guidelines and other relevant global pharmaceutical regulations, guidelines and directives
• Experience with Interactive Voice/Web Response System (IXRS) design, implementation, user acceptance testing and monitoring
• Proficiency with Microsoft applications, electronic data capture systems and inventory management systems
• Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel
• Excellent attention to detail and commitment to providing accurate, high-quality work
• Good organizational skills and ability to manage multiple competing priorities
• Strong interpersonal and team skills to work independently and collaboratively as part of a multidisciplinary team
• Ability to work onsite at the Boston office a minimum of two days per week
• Ability to travel internationally as required

Demonstrates extensive experience in clinical supply management, including supply planning, inventory tracking, and compliance with regulatory standards. Proficient in collaborating with multidisciplinary teams and managing vendor relationships to ensure efficient supply chain operations.

• Clinical Supply Management
• Good Manufacturing Practices (GMP)
• Good Clinical Practices (GCP)
• Interactive Voice/Web Response System (IXRS)
• Inventory Management Systems

• Supply Planning
• Forecasting
• Supply Accountability Tracking
• KPI Reporting
• Root-Cause Analysis

• Excellent Communication Skills
• Attention to Detail
• Organizational Skills
• Interpersonal Skills
• Team Collaboration

• Pharmaceutical Industry
• Biotechnology Industry
• International Clinical Supply
• Good Distribution Practices (GDP)
• International Conference on Harmonization (ICH) Guidelines

• Microsoft Applications
• Electronic Data Capture Systems