The Opportunity

Associate Director, Clinical Supply Chain will play a pivotal role in enabling the success of Relay Tx’s clinical studies by ensuring on-time global supply for new and ongoing clinical studies in a compliant manner. Working as a part of a highly collaborative team, the successful candidate will be responsible for the set up and management of their own studies, mentoring junior team members, providing ad-hoc support across all studies, and executing special projects as needed.   The candidate will have strong analytical, organizational, communication, and proven ability to initiate and manage multiple tasks in a fast-paced, dynamic environment.

Your Role

• Establish supply strategy based on clinical study protocols and input from key cross-functional stakeholders. Work with supply chain leadership to gain cross functional alignment and continually re-evaluate/update as needed. 
• Work closely with clinical operations, program team and other cross functional stakeholders monthly to align on supply planning forecast and timelines for new activities.
• Develop and maintain supply model to identify material requirements and ensure manufacturing plans support agreed to supply planning forecast and supply strategy. Execute scenario planning as needed. 
• Ensure sites and depots are stock to plan.
• Update supply dashboards on monthly basis.
• Proactively identify supply risks and mitigations while working closely with supply chain leadership to ensure prompt, cross functional communication/awareness.
• Lead creation, translations and approvals of label designs while maintaining proper regulatory and quality standards.
• Author and review clinical supply sections of relevant clinical and regulatory documents.
• Author and maintain study specific pharmacy manuals working closely with clinical operations, pharmaceutical development, quality, and other functions as needed.
• Source concomitant and comparator drugs for clinical studies as needed.
• Lead cross functional design, testing, implementation, and management of IXRS systems on assigned studies including vendor selection, specification management, system requirements, testing/acceptance, system updates/modifications and budget management.
• Plan, schedule, and oversee packaging, labeling and distribution operations at clinical supply vendors. Enhance performance by driving improvements and fostering relationships with external vendors.
• Coordinate the collection and generation of required documentation, internally and externally, to support for drug release and shipments to and from clinical supply CMO’s depots and sites (i.e. incoming shipment notifications, import licenses, batch release documents/certificates, QP declarations and certifications, pro-forma invoices, etc.).
• Ensure on-time supply to sites and prompt resolution of supply issues throughout the life of the study (i.e. shipment and storage of investigational product, temperature excursions returns, destruction, etc.)
• Support periodic review, optimization and implementation of SOPs as needed.
• Manage quote requests/approvals, purchase orders and invoices for study specific activities.
• Provide input to and management of budget.
• Ensure documentation in an audit ready state and filed as appropriate (i.e. in quality system or TMF).

Your Background

• BS/BA or equivalent in operations, life sciences, or health-related field
• Minimum of eight to ten (e.g., clinical, pharmaceutics, clinical trial material) pharmaceutical/biotechnology experience
• Demonstrated experience forecasting early phase trials
• In-depth knowledge of IRT functionality and implementation processes
• Experience with investigational drug product primary/secondary packaging and labeling processes
• Experience with distribution and recall processes for investigational products
• Knowledge of cGMPs, cGCPs and relevant FDA and EU regulations including QP activities
• Flexible, detail-oriented, 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
• Able to prioritize multiple tasks, from multiple parties in a fast-paced, dynamic environment under tight timelines