Sr. Manager, Clinical Supply Chain

Alto Neuroscience•Mountain View, CA

18h•$140,000 - $165,000•Onsite

About The Position

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: Bachelors 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 IIII preferred) Strong knowledge of GMP/GDP/GCP and clinical trial supply processes Experience managing vendors and cross-functional stakeholders Preferred Skills: Masters 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. #LI - Onsite

Requirements

Bachelors 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 IIII preferred)
Strong knowledge of GMP/GDP/GCP and clinical trial supply processes
Experience managing vendors and cross-functional stakeholders

Nice To Haves

Masters 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

Responsibilities

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