ABOUT THE COMPANY
Helus Pharma (NASDAQ: HELP) is a clinical stage biopharmaceutical company empowering the healing process by turning Novel Serotonergic Agonists ("NSAs") into Breakthroughs in Mental Health.
Founded in 2019, the company operates in Canada, the United States, the United Kingdom, the Netherlands, and Ireland. Helus Pharma is set to transform the mental health treatment landscape with key near-term milestones including its lead program HLP003, which has been granted FDA Breakthrough Therapy Designation, in Phase 3 development for the adjunctive treatment of Major Depressive Disorder, and HLP004 in development for generalized anxiety disorder.
Helus Pharma has a robust pipeline of proprietary NSAs with potential for expansion into additional mental health indications with high unmet need. The company's mission to help minds heal is supported by a strong intellectual property portfolio and a work force that is driven by compassion and the urgent need for better mental health solutions. The Helus Pharma team is working together to build a pathway to make accessible, scalable, and transformative care available to millions of people worldwide.
POSITION PURPOSE
The Supply Chain and Logistics Director is responsible for planning, coordinating, and executing the end-to-end supply chain activities of DEA and internationally controlled investigational products that support clinical trials. The role leads coordination with clinical operations to ensure accurate clinical forecasts. This role also oversees vendor management of secondary packaging, labeling, and all logistics involved in delivery of investigational drug to sites to ensure each clinical trial site has the correct quantity of investigational product on time and in compliance with global regulatory requirements and Good Manufacturing Practices (GMP). This position partners closely with Clinical Operations, CMC, Quality, CMOs, and external vendors to maintain a seamless flow of materials throughout all phases of clinical development and will be integral in developing future commercial supply strategy and execution..
CORE ACCOUNTABILITIES
- Supply Planning & Forecasting – 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.
- Procurement & Vendor Management – 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.
- Secondary Packaging Oversight – 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.
- Inventory Management – Monitor stock levels, track product expiry, and implement strategies to minimize waste.
- Logistics & Distribution – Oversee domestic and international shipment planning, ensuring compliance with temperature control and controlled substance import/export regulations. Knowledge of DEA and international controlled substance regulations is required.
- 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.
- Regulatory Compliance – 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.
- Risk Management – Identify potential supply risks and develop contingency plans to avoid trial disruptions.
- Cross-Functional Collaboration – Work closely with Clinical Operations, CMC, Quality Assurance, Regulatory Affairs, and Finance teams to align supply strategies with trial needs.
- Commercial Supply Chain
- 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
EDUCATION AND EXPERIENCE
- 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.
CORE COMPETENCIES
- Attention to detail and accuracy
- DEA and International controlled substance material distribution
- Strategic thinking and analytical skills
- Vendor negotiation and relationship management
- Adaptability to changing priorities
- Commitment to quality and compliance