The Sr Manager, Clinical Supply Chain manages all aspects of supplies for clinical studies, including investigational medicinal product and comparators. The candidate will play a pivotal role in enabling the success of Relay’s trials by ensuring that all study patients are supplied in a timely and compliant manner.  The candidate will have strong analytical, organizational, communication, networking, and team skills, and will demonstrate a proven ability to take initiative and manage multiple tasks in a fast-paced, dynamic environment.

Responsibilities:

• Responsible for forecasting clinical supply needs for regional and global Phase I, II and III studies based on an in depth understanding of clinical trial protocols and detailed discussions with Clinical Operations and Regulatory on demand assumptions
• Reviews IP inventory levels at depots and sites and takes anticipatory actions to avoid interruptions to supply.
• Procures concomitant and comparator drugs for clinical trials as needed
• Authors English label text, coordinates translations, and approves label design for investigational drugs used in clinical trials while maintaining proper regulatory and quality standards
• Plans, schedules, and oversees packaging and labeling operations at clinical supply vendors
• Reviews and approves clinical supply packaging and labeling batch records
• Reviews Clinical Supply sections of all relevant clinical and regulatory documents
• Monitors depots and sites for proper storage of all investigational product
• Dispositions temperature excursions and improves processes to minimize the impact of excursions
• Coordinates and tracks drug product shipments to and from all clinical sites
• Facilitates import and export documents such as: Import License, special permits, Proforma Invoice, and additional documentation required to transport clinical trial material (CTM) to its final destination
• Reviews/approves user requirements and specifications and performs User Acceptance Testing (UAT) on new and existing IXRS systems
• Coordinates returns and destruction of investigational product at sites and depots
• Develops and reviews CRO/vendor proposals and contracts for packaging/labeling/distribution of investigational product
• Collaborates with Quality to author and review CTM SOPs and business practices as needed
• Maintains documentation in an audit ready state

Requirements:

• BS/BA or equivalent in operations, life sciences, or health-related field
• Minimum of three to five years relevant (e.g., clinical, pharmaceutics, clinical trial material) pharmaceutical/biotechnology experience
• Experience with investigational drug product primary/secondary packaging and labeling processes
• Experience with distribution and recall processes for investigational products
• Experience with CMO contracts and vendor management
• Clinical study site interaction skills
• Knowledge of cGMPs and relevant FDA and EU regulations
• Detail orientated and process focused
• Excellent communication (written and oral) and interpersonal skills
• Adept and diplomatic in interacting with senior management both within the organization and with external organizations, consultants and vendors
• Work effectively with team members across all levels of the organization
• Able to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines

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