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 employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
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