BBOT ยท 1 week ago
Director/Sr. Director, Clinical Supply Chain
United States
Full-time
Remote
Director/Executive
$220K/yr - $288K/yr
10+ years expBBOT is a clinical-stage biopharmaceutical company focused on advancing a pipeline of novel therapeutics targeting RAS and PI3K malignancies. The Director/Sr. Director, Clinical Supply Chain will be responsible for developing and executing strategies for clinical trial supplies, managing inventory, and ensuring compliance with regulatory standards.
Biotechnology
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
Qualification
Required
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
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