About Sail:
Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail’s platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering.
The Role:
The Associate Director/Director of Clinical Supply Chain will be responsible for the strategic planning, execution, and oversight of end-to-end clinical supply operations across Sail’s clinical programs. This role will lead clinical supply strategy from first-in-human through late-stage trials, ensuring uninterrupted supply of critical materials, intermediates, products and finished good from/between suppliers through to clinical sites while maintaining regulatory compliance, cost control, and operational excellence. This position requires strong cross-functional leadership, hands-on execution capability, and deep expertise in global transportation logistics and clinical supply chain management within a biotech environment.
Responsibilities:
- Develop and execute clinical supply strategies for all clinical programs, aligned with clinical development plans and CMC timelines.
- Lead demand forecasting, supply planning, and inventory management
- Define packaging, labeling, and distribution strategies appropriate for trial design, geography, and regulatory requirements.
- Oversee clinical packaging, labeling, storage, and global distribution activities through CMOs, CPOs, depots, and logistics providers.
- Ensure timely availability of clinical supplies to investigational sites, minimizing risk of stock-outs or excess inventory.
- Manage external vendors (CMOs, packaging/labeling vendors, depots, couriers).
- Establish and manage contracts, budgets, KPIs, and performance reviews for supply chain partners.
- Serve as the primary supply chain interface with external manufacturing and logistics partners.
- Partner closely with Clinical Operations, CMC, Quality, Regulatory, and Finance to align supply plans with trial execution and regulatory strategy.
- Provide supply chain risk assessments and mitigation plans to program teams and leadership.
- Support clinical protocol development by advising on supply chain feasibility and complexity.
- Ensure all clinical supply activities comply with GxP, ICH, FDA, EMA, and global regulatory requirements.
- Support audits and inspections related to clinical supply operations.
- Author, review, and approve SOPs, plans, and supply-related documentation.
- Develop and manage clinical supply chain budgets, forecasts, and cost controls.
- Implement process improvements, digital tools, and best practices to enhance efficiency and scalability.
- Build and scale clinical supply chain capabilities as Sail’s pipeline grows.
Required Qualifications:
- Bachelor’s degree in Supply Chain, Life Sciences, Engineering, or a related field (advanced degree preferred).
- 8+ years of direct experience in clinical supply chain, pharmaceutical supply chain, or related roles in biotech/pharma.
- Proven experience supporting Phase 1–3 clinical trials, including global studies.
- Strong knowledge of GxP, clinical packaging/labeling, and global distribution requirements.
- Demonstrated ability to manage external vendors and complex cross-functional projects.
- Excellent communication, problem-solving, and leadership skills.
- Demonstrated experience managing global clinical supply chains for multiple chemical and biological entities.
- Experience in a clinical-stage or high-growth biotech environment.
Preferred Qualifications:
- Experience driving clinical supply chain operations.
- Familiarity with IRT/RTSM systems and clinical supply forecasting tools.
- Experience supporting regulatory inspections and audits.
- Technical background in clinical or commercial manufacturing of multiple therapeutic modalities i.e. small molecules, ADC and biologics
Salary Range: $175,000 - $240,000
Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.