The Company
Elion Therapeutics is a clinical-stage biotechnology company headquartered in Boston, focused on combating life-threatening invasive fungal infections. Our goal is to provide patients and clinicians with new therapies that address critical unmet needs in antifungal efficacy and safety. The company has attracted a world-class team of infectious disease scientists and drug developers, and its work has drawn meaningful interest from both private investors and U.S. government agencies.
Position Overview
The Manager, Supply Chain will be responsible for managing and monitoring ongoing clinical trial operations and systems to ensure supply continuity across all phases. In addition, the role supports readiness for clinical label and pack set up, global trial distribution network, and clinical trial systems for upcoming clinical studies. Reporting to the Senior Director of Supply Chain, this role will work closely with Clinical Operations, Regulatory Affairs, Quality Assurance, and external partners to manage global clinical supply planning, packaging, labeling, distribution, and logistics activities.
Key Responsibilities
- Lead the planning and execution of clinical trial material supply for Elion’s global clinical studies, including forecasting, packaging, labeling, and distribution.
- Manage external label/pack and distribution vendors to ensure on-time delivery of high-quality clinical supplies.
- Develop, maintain, and execute an optimal supply strategy with proactive planning, appropriate lead-time, and replenishment quantities to ensure compliance and continuity of clinical supplies, including active, placebo, and comparator sourcing.
- Coordinate cold chain sample and bulk GMP international shipments between end-to-end manufacturing sites, testing facilities, and warehouses.
- Oversee Interactive Response Technology (IRT) vendor throughout clinical trial duration, in collaboration with Clinical Operations.
- Support development and updates of pharmacy manuals for Phase I–III trials.
- Identify, assess, and proactively communicate supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity.
- Manage quality events, including deviations, investigations, CAPAs, specifications, and change controls.
Qualifications
- Bachelor’s degree in life sciences, business, or equivalent required.
- Minimum 5 years of related experience in the pharmaceutical or biotech industry with at least 3 years of direct experience in global clinical supply management supporting early through late stage clinical phases.
- Deep understanding of global GMP regulatory expectations and quality systems.
- Experience managing contract manufacturing sites and global supply chains.
- Demonstrated ability to work independently and professionally while managing multiple responsibilities.
- Proficient with Excel, Smartsheet, IRT, and inventory management systems.
- Strong communication, organizational, time management, interpersonal, conflict resolution, and problem-solving skills.
- Comfortable operating in a lean, fast-paced, and highly-collaborative, small or emerging biotech startup environment.
- Ability to travel up to 20% domestically and internationally.
- Boston-based required.
