BBOT ยท 21 hours ago
Head of Supply Chain
United States
Full-time
Remote
Director/Executive
15+ years expBBOT is seeking an Executive Director for their Clinical Supply Chain team, who will lead and manage the clinical supply chain operations. The role involves developing strategies, overseeing inventory management, ensuring regulatory compliance, and fostering collaboration across various teams to support the oncology pipeline.
Biotechnology
Responsibilities
Lead the development and execution of comprehensive strategies for planning, sourcing, and distribution of clinical trial supplies to support global clinical studies, ensuring alignment with organizational goals and long-term pipeline objectives
Oversee sourcing of commercial comparators, including strategic due diligence, documentation, vendor coordination, and compliance with sourcing regulations across multiple countries
Partner with the SVP, CMC, clinical development, and executive leadership to align on clinical supply needs, timelines, resource allocation, and enterprise-wide risk management
Direct the end-to-end clinical supply chain process from forecast through to final delivery to clinical sites, ensuring compliance with protocol requirements, international regulations, and seamless integration across programs; provide executive oversight to optimize efficiency and scalability
Oversee the creation and refinement of advanced forecasting models for clinical trial material needs, incorporating clinical trial protocols, patient enrollment rates, country-specific requirements, and scenario-based planning to inform strategic decisions
Lead IRT system strategy, including setup, user acceptance testing (UAT), and ongoing data maintenance for supply chain configuration, tracking, and optimization across the organization
Direct inventory tracking, expiry management, and batch traceability in alignment with trial timelines and regulatory requirements; establish policies to minimize risks and ensure program continuity
Manage inventory levels across clinical sites and distribution centers, minimizing excess while ensuring supply continuity; anticipate and mitigate operational challenges to prevent trial disruptions, while guiding team responses
Champion clinical supply budgets, driving cost-effective sourcing and distribution while optimizing resource allocation across programs; provide financial oversight and reporting to senior leadership
Establish and enforce enterprise-wide standards to ensure all clinical supply chain activities comply with regulatory requirements, including current Good Manufacturing Practice (cGMP), Good Distribution Practices (GDP), and country-specific standards
Lead quality assurance processes for clinical materials, including packaging, labeling, and distribution, to maintain regulatory compliance and product integrity; foster a culture of quality excellence
Collaborate with the quality team to resolve compliance or quality issues; direct deviation management, temperature excursion resolution, audit readiness, and continuous improvement initiatives; represent the function in regulatory inspections and audits
Act as the executive point of contact for all clinical supply chain-related matters, providing strategic guidance to internal and external stakeholders at all levels
Foster collaboration with clinical operations, regulatory, manufacturing, and senior leadership teams to align clinical trial needs with supply timelines and organizational priorities; drive cross-functional initiatives to enhance integration
Deliver executive-level updates to senior management, including the SVP, CMC, on clinical supply status, inventory levels, program risks, and strategic opportunities; serve as a key advisor on supply chain implications for business decisions
Oversee relationships with external vendors, including manufacturers, packaging providers, and logistics companies, ensuring timely, compliant, and high-performance delivery of clinical trial materials; develop long-term partnership strategies
Lead the selection, qualification, and ongoing management of third-party suppliers and service providers; establish governance frameworks for vendor performance
Ensure adherence to Good Manufacturing Practices (GMP) and regulatory requirements for procurement and distribution of clinical materials; set organizational standards for vendor risk assessment
Direct contract negotiations, ensuring alignment with agreements, performance metrics, timelines, and overall business objectives; optimize vendor portfolios for cost, quality, and innovation
Drive process improvements within clinical supply chain management, implementing best practices and innovative solutions to enhance efficiency, scalability, and agility
Build, mentor, and lead a high-performing Clinical Supply Chain team; manage staff recruitment, development, and performance to support program growth
Oversee all Clinical Supply Chain programs, ensuring strategic alignment, resource optimization, and successful execution in a dynamic biotech environment
Qualification
Required
Bachelor's degree in Supply Chain Management, Life Sciences, or related field
Minimum of 15 years of experience in clinical supply chain management or a related field
At least 7-10 years in a senior leadership role overseeing teams and programs
In-depth knowledge of clinical trial operations, cGMP/GDP regulations, and global clinical supply chain best practices, preferably in oncology or rare diseases
Exceptional negotiation, vendor management, and contract management skills with a track record of building strategic partnerships
Outstanding communication, interpersonal, and leadership skills; proven ability to influence at the executive level
Demonstrated success in building and leading teams, collaborating across cross-functional groups, and managing multiple priorities in a fast-paced environment
Strong analytical skills with expertise in forecasting, risk management, and inventory optimization
Preferred
Master's or advanced degree
Benefits
Annual bonus
Stock-based long-term incentives
Medical
Dental
Vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase