Clinical Supply Services Manager

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.

Requirements

• 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.

Preferred Qualifications

• 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).

Benefits

• 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 (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. 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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