Sr. Manager, Clinical Supply Chain

PRIMARY ROLE

The Manager, Clinical Supply Chain is responsible for planning, execution, and oversight of clinical trial supply activities to ensure uninterrupted, compliant, and cost-effective delivery of investigational products and ancillary materials. This role partners cross-functionally with Clinical Operations, CMC, Quality, Regulatory, and external vendors to support global clinical trials from early-stage through late-stage development.

WHAT YOU'LL DO

Clinical Supply Planning & Execution

• Develop and manage clinical supply strategies aligned with clinical trial timelines and enrollment forecasts
• Create and maintain demand forecasts, supply plans, and inventory strategies for investigational medicinal products (IMPs) and comparators
• Based on study protocol, design clinical supplies to align with study requirements, country labeling requirements and regulatory requirements.
• Oversee packaging, labeling, distribution, and return/destruction of clinical supplies
• Manage the design of the Interactive Response Technology (IRT) system to meet protocol and cross functional team requirements.
• Ensure uninterrupted supply to clinical sites and depots across global regions
• Evaluate and maintain the study blind from start up to study completion
• Manage temperature excursions related to clinical supplies for ongoing studies

Vendor & Partner Management

• Manage relationships with CMOs, packaging/labeling vendors, depots, couriers, and IRT providers
• Lead vendor selection, contracting support, performance monitoring, and issue resolution
• Coordinate external partners to ensure adherence to timelines, quality standards, and budgets

Cross-Functional Collaboration

• Partner with Clinical Operations to align supply strategy with protocol design, enrollment plans, and country activation
• Collaborate with CMC and Quality to ensure GMP compliance and release readiness
• Support Regulatory and QA activities related to clinical supply documentation and inspections
• Collaborate with Finance to support budgets, invoices and billing related to clinical supplies

Compliance & Quality

• Ensure compliance with GMP, GCP, GDP, and applicable regulatory requirements
• Support audits, inspections, and quality investigations related to clinical supplies
• Maintain accurate documentation, SOPs, and supply records

Budget & Risk Management

• Develop and manage clinical supply budgets and forecasts
• Identify supply risks and implement mitigation strategies (e.g., demand variability, manufacturing delays)
• Track costs and drive continuous improvement and cost efficiencies

Systems & Reporting

• Utilize clinical supply systems (e.g., IRT, inventory management tools) to track supply status and performance
• Prepare regular supply metrics, dashboards, and executive updates

LOCATION

Onsite - Mountain View, CA

TRAVEL REQUIREMENTS

Less than 10%

SALARY RANGE

$140,000 - $165,000

*depending on qualifications and experience level

QUALIFICATIONS

Required Skills:

• Bachelor’s degree in Supply Chain, Life Sciences, Engineering, or related field
• 5+ years of experience managing clinical trial supply chains. Additional clinical operations, or pharmaceutical manufacturing experience preferred
• Advance understanding of fundamental clinical trial designs and the application to packaging and labeling of clinical drug product
• Experience supporting QP process
• Advance knowledge with design and maintenance of IRT systems
• Hands-on experience supporting clinical trials (Phase I–III preferred)
• Strong knowledge of GMP/GDP/GCP and clinical trial supply processes
• Experience managing vendors and cross-functional stakeholders

Preferred Skills:

• Master’s degree (MBA, MS, or equivalent)
• Experience in biotech or emerging pharma environment
• Clinical operations, or pharmaceutical manufacturing experience
• Global clinical trial supply experience
• Familiarity with IRT systems and forecasting tool

WHY ALTO

At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics.

Alto Neuroscience is an equal-opportunity