Clinical Supply Manager

Job Title: Clinical Supply Manager

Department: Clinical

Reports To: Head of Clinical Operations

Job location: 100% onsite - Los Angeles, California

Position Summary

The Clinical Supply Manager is responsible for planning, coordinating, and overseeing clinical investigational product supply activities to ensure uninterrupted availability of investigational product for clinical studies.

The position manages clinical supply forecasting, inventory planning, packaging and labeling coordination, IRT integration, storage, distribution, shipment management, expiry management, reconciliation and return/destruction activities throughout the clinical trial lifecycle.

The Clinical Supply Manager partners closely with Clinical Operations, Manufacturing, Quality Assurance, Regulatory Affairs, Clinical Trial Project Managers, IRT vendors, Shipping & Distribution and investigative sites to ensure clinical supplies are available in accordance with study requirements, enrollment projections, applicable regulations, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and company procedures.

Key Responsibilities:

• Develop and maintain clinical supply forecasts based on protocol requirements, randomization, ratios, enrollment projections, treatment duration, site activation schedules, screen failure assumptions and expected attrition.
• Determine investigational product requirements by study, treatment group, site, and enrollment period.
• Establish appropriate inventory buffers and contingency supply.
• Monitor actual enrollment and consumption against forecast assumptions.
• Update forecasts based on changes in enrollment, site activation, protocol design, manufacturing availability, or study timelines.
• Coordinate supply requirements with Manufacturing and Quality to ensure adequate released inventory.
• Maintain oversight of available, quarantined, released, allocated, shipped, returned, expired, and destroyed clinical inventory.
• Maintain accurate lot/batch and expiry information.
• Monitor inventory levels and shelf life.
• Develop strategies for lot transitions and expiry management.
• Perform inventory reconciliation between internal records, IRT, distribution records, and site accountability records as appropriate.
• Coordinate clinical packaging and labeling activities.
• Develop and review clinical label specifications and label text.
• Ensure labels comply with protocol, regulatory, storage, and study requirements.
• Coordinate variable-data printing, lot information, expiration dating, kit/carton identification, and other study-specific labeling requirements.
• Maintain appropriate packaging and labeling documentation.
• Coordinate with Quality for approval and release of packaged clinical supplies.
• Serve as the Clinical Supply functional representative for IRT design and implementation.
• Define clinical supply requirements for IRT configuration
• Participate in development and review of IRT specifications and User Acceptance testing (UAT).
• Establish inventory, shipment, resupply, lot expiry and accountability requirements within IRT
• Review site inventory and resupply parameters
• Monitor IRT inventory and shipment data
• Oversee shipment requests
• Monitor delivery status and investigate shipment delays
• Ensure sites confirm receipt of clinical supplies
• Ensure clinical supplies and available before and throughout site enrollment
• Coordinate initial and resupply shipments
• Develop processes for investigational product returns and destruction
• Maintain clinical supply documentation in an inspection-ready state

Qualifications:

Required

• Bachelor's degree in Life Sciences, Supply Chain Management, Pharmacy, Chemistry or related discipline
• Approximately 5-8 years of pharmaceutical/biotechnology supply-chain experience
• Experience supporting Phase II and/or Phase III clinical trials
• Experience with clinical supply forecasting and inventory management
• Experience with packaging, labeling, distribution, and temperature-controlled clinical supplies
• Working knowledge of GMP, GDP, GCP, and applicable FDA requirements
• Experience with IRT/IWRS systems
• Strong project-management and organizational skills
• Excellent written and verbal communication skills

Preferred

• Experience working with biologics or other temperature-sensitive investigational products
• Experience with specialty couriers, cold chain shipping and late stage/Phase III clinical development

Travel Requirements

• Approximately 10-20% of travel, depending on business needs

Salary Range: The annual salary range for this position is $82,000.00 -$117,000.00. Actual compensation will be based on qualifications, experience, education, skills, and business needs. This range represents the company's good-faith estimate of the expected compensation for the role at the time of posting.

Armata offers an excellent benefits package designed to support employees' health, financial well-being, and work-life balance. Benefits include comprehensive health insurance options, including medical, dental, and vision coverage; a flexible spending account (FSA); life insurance; short-term and long-term disability insurance; paid holidays; vacation and sick days; a 401(K) plan with employer match; and participation in an equity incentive plan.

About Armata Pharmaceuticals, Inc.:

Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing.

Armata is proud to be an Equal Opportunity and Affirmative Action Employer. We are committed to providing equal employment opportunities to all qualified applicants, regardless of race, color, religion, sex (including sexual orientation and gender identity), national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you are interested in applying for the position, please submit your resume with cover letter to careers@armatapharma.com.

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