Associate Director, Clinical Supply
Aditum Bio · Cambridge, MA · 4 days ago
HybridFull-time
Responsibilities
- Lead end-to-end clinical supply planning activities across portfolio companies and phases of development.
- Ensure supply plans align with program timelines, enrollment assumptions, and development objectives.
- Support clinical trial material production and distribution activities.
- Support manufacturing campaigns, packaging runs, labeling activities, shipment planning, and global distribution of investigational products and ancillary supplies.
- Develop and implement strategies to ensure study blinding requirements are met.
- Manage clinical supply forecasting and inventory oversight.
- Create and maintain demand forecasts, inventory plans, and supply scenarios for investigational product and for any comparators and/or auxiliary items required to support study execution while minimizing waste, shortages, and excess inventory.
- Achieve accurate tracking of inventory, shipments, forecasts, and supply performance indicators while supporting inspection readiness and compliance requirements.
- Identify and mitigate supply risks by proactively assessing potential supply chain constraints, manufacturing risks, and inventory vulnerabilities, and developing contingency plans to maintain uninterrupted clinical trial support.
- Cook up coordination with external supply chain partners and vendors.
- Serve as the primary operational liaison for CMOs, packaging and labeling vendors, depots, IRT providers, and logistics partners to ensure timely and compliant supply execution.
- Collaborate closely with cross-functional stakeholders.
- Partner with Manufacturing, Clinical Development/Operations, Regulatory Affairs, Quality Assurance, and portfolio company leadership teams to align clinical supply activities with broader program objectives.
- Contribute to process development across the Aditum Bio portfolio.
- Help establish scalable clinical supply planning practices, vendor management frameworks, and operational standards that can be leveraged across multiple portfolio companies.
Qualifications
- Bachelor's degree in Life Sciences, Engineering, Supply Chain, or related discipline; advanced degree preferred.
- 5+ years of experience in clinical supply chain, clinical manufacturing operations, or pharmaceutical/biotech supply management.
- Experience working in emerging biotech companies and/or supporting multiple development programs simultaneously.
- Experience supporting Phase I/II clinical trials, including forecasting, packaging, labeling, distribution, and inventory management.
- Demonstrated experience managing external vendors, CMOs, depots, and logistics providers.
- Strong understanding of GxP requirements and clinical supply chain regulations.
- Excellent project management, organizational, and communication skills.
- Ability to operate independently in a fast-paced, highly collaborative environment with competing priorities.