Clinical Supply Services Manager

For more information, please visit www.Encoded.com.

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.

• 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.

• Bachelor's degree in Supply Chain Management, Life Sciences, Engineering, or a related field. Advanced degree preferred.
• Minimum of 5-7 years of experience in clinical supply chain management, preferably within the biotech or pharmaceutical industry, with a focus on gene therapy, cell therapy, or biologics.
• Proven experience in managing clinical supply chains for multiple clinical programs across various global regions.
• Strong experience in managing third-party vendors, including contract manufacturing organizations (CMOs), distribution vendors, and clinical supply depots.
• Knowledge of GMP, GDP, ICH guidelines, and other relevant regulatory requirements related to clinical supply management.
• Exceptional project management skills with the ability to prioritize tasks and manage multiple projects simultaneously.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal stakeholders and external partners.
• Strong problem-solving skills and attention to detail.
• Proficient in supply chain management software and systems.

• Experience in gene therapy or other advanced therapies.
• Knowledge of cold chain management and temperature-sensitive drug products.
• Familiarity with regulatory requirements for clinical trials in various regions (e.g., FDA, EMA, PMDA).

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Fully stocked kitchen

Employees will also enjoy designated paid holidays throughout the calendar year.

Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.

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