Position Summary:
Upstream Bio is seeking an experienced and strategic Vice President, Supply Chain to lead the development and execution of our global clinical and commercial supply strategies. This role will oversee supply chain operations across all programs from current phase 2 programs through commercialization. As a key member of the Technical Operations leadership team reporting into the Chief Technical Officer, the VP will ensure the timely, compliant, and cost-effective supply of clinical trial materials and commercial product, while building a fit-for-purpose organization capable of scaling with the company’s pipeline and market ambitions.
The ideal candidate brings a track record of successfully managing complex global clinical trial supply chains, navigating regulatory requirements, and launching commercial products in the biotech or pharmaceutical industry, including early access program program considerations. This leader will bring strategic foresight, strong cross-functional collaboration skills to align stakeholders, and operational discipline to deliver results in a dynamic, fast-paced environment.
Key Responsibilities:
Strategy & Leadership
- Establish the clinical and commercial supply chain strategies, creating an integrated supply chain to successfully launch Upstream Bio’s first biologic combination products.
- Lead and drive cross-functional alignment and integration across Clinical Operations, Regulatory, Quality, Technical Operations, Finance, and Commercial functions.
- Define standards and approach for business process management across the supply chain and drive excellence in end-to-end operations through identification and management of supply chain key performance indicators (KPIs).
- Establish and lead Clinical Demand & Operations Planning (CD&OP) and Sales & Operations Planning (S&OP) processes to align cross-functional teams and drive business plans to improve supply planning, increase service levels, optimize inventory, and achieve the company’s financial targets.
- Build and scale internal capabilities and infrastructure to support long-term growth and operational excellence, including supply chain risk mitigation.
- Optimize existing integrated global supply chain strategy for clinical programs.
- Anticipate and plan for future needs including Phase 3 trial readiness and commercial launch.
- Provide leadership and direction to the supply chain function, including supply planning and forecasting, logistics, distribution and vendor management.
- Build, mentor, and scale a high-performing global supply chain team.
Clinical and Commercial Supply Operations
- Lead end-to-end clinical trial and commercial supply planning, including manufacturing forecasting, inventory management, logistics and distribution in compliance with GxP requirements.
- Ensure timely delivery of clinical supplies across global sites while minimizing risk and waste.
- Lead commercial supply and launch readiness including launch planning, inventory and distribution strategies, serialization, regulatory compliance, including early access programs
- Manage supply risk and ensure continuity planning across geographies and products.
- Establish strategies for implementation of systems and tools to support commercial operations such as future ERP/MRP integration and demand/supply planning platforms.
Vendor and Partner Management
- Establish robust metrics and governance for supply chain performance monitoring and continuous improvement opportunities.
- Accountable for budget related to Upstream Bio’s integrated supply chain
- Negotiate and manage contracts to ensure cost-effective, high-quality, and compliant services.
- Identify, qualify, and oversee external vendors and CMOs/CPOs for supply chain services.
Compliance and Regulatory Support
- Ensure compliance with global regulatory requirements related to clinical and commercial supply chain operations.
- Support regulatory filings, inspections, and inquiries related to product supply and logistics.
- Oversee supply chain SOPs, systems, and controls.
Qualifications:
- Demonstrated success in managing global clinical trial supply and proven track record of launching commercial products including building and scaling supply chain functions.
- Leadership in cultivating and enabling a culture of cross functional collaboration and transparency.
- Expertise establishing serialization and distribution strategies and implementation.
- Strong communication, leadership, change management and problem-solving skills.
- Ability to operate both strategically and tactically in a fast-paced, evolving environment.
- Experience in mentoring and coaching team members and conducts oneself in a way that encourages team members to ask for advice and help when needed
- Lead by example, giving team members a clear direction and model to follow and inspire employees to exceed expectations. Has a strong command for change management.
- 15+ years of progressive experience in supply chain leadership roles within the biotech or pharmaceutical industry, including 5+ years at the executive level.
- Bachelor’s degree in a scientific or technical field required; advanced degree (MBA, MS, PhD) preferred.
About Upstream Bio:
Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.