[Remote] Senior Director Supply Chain & Logistics

Note: The job is a remote job and is open to candidates in USA. Helus Pharma is a clinical stage biopharmaceutical company focused on innovative mental health treatments. The Senior Director of Supply Chain & Logistics will be responsible for overseeing the end-to-end supply chain activities for investigational products, ensuring compliance with regulatory requirements, and collaborating with various internal and external teams to support clinical trials.

Responsibilities
• Develop and maintain clinical supply and demand forecasts based on study protocols, enrollment projections, and site performance
• Lead the development and execution of clinical supply plans across assigned studies
• Coordinate forecasting, demand planning, and inventory management to ensure adequate supply levels at each clinical depot and clinical site
• Track investigational product usage, expiry, and resupply needs across global clinical sites
• Collaborate with internal teams (Clinical Operations, Regulatory, Quality, CMC) to align supply chain activities with study timelines
• Source, negotiate, and meticulously manage relationships with suppliers, contract manufacturers, and logistics providers
• Serve as a key point of contact for CMOs, packaging vendors, depots, and logistics partners
• Hold all vendors fully accountable for on time, high-quality delivery to ensure zero disruption to clinical trial operations
• Drive resolution for any vendor performance issues
• Coordinate production schedules for final labeling and packaging
• Oversee clinical labeling, packaging, and distribution activities to ensure timely, high quality, and cost-effective execution
• Partner with the CMC team on forecasting and availability
• Monitor stock levels, track product expiry, and implement strategies to minimize waste
• Oversee domestic and international shipment planning, ensuring compliance with temperature control and controlled substance import/export regulations
• Manage shipment scheduling, temperature-controlled logistics, and distribution activities with third-party depots and couriers
• Monitor shipment status, resolve delays, and ensure proper documentation for global import/export activities
• Maintain oversight of packaging, labeling, and kitting activities for clinical trial materials
• Navigate and manage DEA regulations and specific country-controlled substance requirements including import / export licenses
• Ensure all supply chain activities adhere to GMP, GDP, and applicable regulatory guidelines
• Ensure all supply chain activities comply with GxP, ICH, and regional regulatory requirements
• Ensure all supply chain activities comply with controlled substance regulations
• Maintain accurate records in supply chain systems (e.g., IRT/RTSM, ERP, inventory tools)
• Support audits, inspections, and quality investigations related to clinical supply
• Identify potential supply risks and develop contingency plans to avoid trial disruptions
• Work closely with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, and Finance teams to align supply strategies with trial needs
• Serve as a key architect in developing future commercial supply strategy, optimizing end-to-end distribution models, and ensuring seamless execution across manufacturing, quality, regulatory, and commercial teams
• Oversee commercial launch planning, demand forecasting, inventory optimization, and distribution network design to support market launch

Skills
• Bachelor's degree in Supply Chain Management, Life Sciences, or related field
• 10+ years of experience in supply chain and pharmaceutical logistics
• Strong knowledge of GMP, GDP, and ICH guidelines
• Strong knowledge of controlled substance regulations
• Proficiency in supply chain planning tools
• Excellent organizational, problem-solving, and communication skills
• Ability to manage multiple projects across numerous clinical sites in a fast-paced, deadline-driven environment
• Future ability to roll over into commercial supply chain

Company Overview
• Helus Pharma is a biopharmaceutical company that develops psychedelic therapeutics for mental health conditions. It is a sub-organization of Clarmin. It was founded in 2019, and is headquartered in Toronto, Ontario, CAN, with a workforce of 51-200 employees. Its website is https://www.helus.com/.

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