Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

The Clinical Supply Services Manager will play a key role in ensuring the seamless execution of clinical trial supply activities for multiple gene therapy programs in various global regions. This role is responsible for managing all aspects of clinical supply planning, production, distribution, and tracking, working closely with internal stakeholders, third-party vendors, and clinical teams. The ideal candidate will have strong expertise in clinical supply chain management, preferably in a gene therapy or biotechnology setting, with experience in managing complex supply chains across global clinical trials.

Responsibilities

• Lead and manage the end-to-end clinical supply chain process for multiple clinical gene therapy programs across different regions.
• Develop, implement, and monitor clinical supply strategies, including demand planning, forecasting, production, and distribution of clinical trial materials.
• Collaborate closely with internal stakeholders (e.g., Clinical Operations, Regulatory, Quality, Manufacturing) to ensure clinical supply needs are met across all programs.
• Act as the primary point of contact for third-party vendors (CMOs, depots, couriers) and manage relationships to ensure timely and quality delivery of clinical supplies.
• Ensure compliance with regulatory requirements, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other relevant guidelines for clinical supplies.
• Monitor and manage inventory levels across global depots, ensuring optimal supply levels to avoid shortages or delays in clinical trials.
• Oversee packaging, labeling, and distribution of clinical trial materials in accordance with study protocols and country-specific requirements.
• Develop and maintain supply chain documentation, including protocols, work instructions, and supply chain plans.
• Manage supply-related risks and implement mitigation strategies to ensure continuity in clinical trials.
• Track and report key performance indicators (KPIs) related to clinical supply chain performance, ensuring continuous improvement.
• Support the budgeting process for clinical supply services, ensuring cost-effective solutions are implemented.
• Drive process improvements and implement best practices for clinical supply chain operations.