[Remote] Clinical Supply Chain Contractor

Note: The job is a remote job and is open to candidates in USA. BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. They are seeking a highly motivated and experienced Clinical Supply Chain professional to develop and execute strategies for the planning, sourcing, and distribution of clinical trial supplies to support global clinical studies.

Responsibilities

• Develop and execute strategies for the planning, sourcing, and distribution of clinical trial supplies to support global clinical studies
• Support sourcing commercial comparators, including due diligence, documentation, vendor coordination, and compliance with sourcing regulations in different countries
• Collaborate with the SVP, CMC, and clinical development teams to align on clinical supply needs, timelines, and resource planning
• Oversee the end-to-end clinical supply chain process from forecast through to final delivery to clinical sites in accordance with protocol requirements and international regulations, ensuring timely and efficient supply to support trial timelines
• Develop accurate forecasting models for clinical trial material needs based on clinical trial protocols, patient enrollment rates, and country-specific requirements
• Manage IRT system setup, user acceptance testing (UAT), and ongoing data maintenance for supply chain configuration and tracking
• Track inventory, expiry, and batch traceability in alignment with trial timelines and regulatory requirements
• Monitor and manage inventory levels, ensuring proper stock levels at clinical sites and distribution centers while minimizing excess inventory
• Anticipate challenges in supply chain operations and develop mitigation strategies to prevent delays or disruptions in clinical trials
• Monitor the clinical supply chain to ensure continuity and resolve any supply chain-related challenges that may impact trial timelines
• Manage clinical supply budgets and ensure cost-effective approaches to sourcing and distribution
• Coordinate drug accountability, returns, reconciliation, and destruction in accordance with GxP and SOPs
• Ensure clinical supply chain activities meet all regulatory requirements, including current Good Manufacturing Practice (cGMP), Good Distribution Practices (GDP), and other applicable country-specific standards
• Oversee quality assurance processes for clinical materials, including packaging, labeling, and distribution, to ensure regulatory compliance and product integrity
• Work closely with the quality team to resolve any compliance or quality issues related to clinical trial materials. Support deviation management, temperature excursion resolution, and audit readiness efforts
• Serve as the primary point of contact for internal stakeholders on all clinical supply chain-related matters
• Collaborate with the clinical operations, regulatory, and manufacturing teams to ensure alignment of clinical trial needs and supply timelines
• Provide regular updates to senior management, including the SVP, CMC, on the status of clinical supply activities, inventory levels, and any potential risks
• Manage relationships with external vendors, including manufacturers, packaging providers, and logistics companies, to ensure timely and compliant delivery of clinical trial materials
• Oversee the selection and qualification of third-party suppliers and service providers
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements for the procurement and distribution of clinical materials
• Negotiate contracts and ensure adherence to agreements, performance metrics, and timelines
• Drive process improvements within clinical supply chain management, implementing best practices

Skills

• Bachelor's degree in Supply Chain Management, Life Sciences, or related field (Master's preferred)
• Minimum of 10 years of experience in clinical supply chain management or a related field, with at least 3-5 years in a leadership role
• In-depth knowledge of clinical trial operations, cGMP/GDP regulations, and global clinical supply chain best practices
• Strong negotiation, vendor management, and contract management skills
• Outstanding communication, interpersonal, and leadership skills
• Proven ability to collaborate effectively across cross-functional teams, external partners and manage multiple priorities in a fast-paced environment
• Analytical skills with the ability to forecast and manage supply chain risks and inventory

Company Overview

• 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. It was founded in undefined, and is headquartered in South San Francisco, California, US, with a workforce of 51-200 employees. Its website is https://www.bbotx.com.

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