Associate Director / Director, Clinical Supply Chain

Job Summary:

The Associate Director/Director of Clinical Supply Chain will be responsible for the strategic oversight and operational management of clinical supply chain activities for BBOT clinical programs. This role involves coordinating the timely and efficient delivery of clinical trial materials and supplies, ensuring compliance with regulatory requirements, and overseeing inventory management across clinical trials. The position will directly report to the Senior Vice President (SVP) of Chemistry, Manufacturing, and Controls (CMC) and work collaboratively with cross-functional teams, including clinical operations, regulatory affairs, and manufacturing.

Key Responsibilities:

Clinical Supply Chain Strategy & Management:

• Develop and execute strategies for the planning, sourcing, and distribution of clinical trial supplies to support global clinical studies.
• 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, ensuring timely and efficient supply to support trial timelines.

Inventory Management & Forecasting:

• Develop accurate forecasting models for clinical trial material needs based on clinical trial protocols, patient enrollment rates, and country-specific 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.

Regulatory Compliance & Quality Assurance:

• 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.

1. Stakeholder Communication & Cross-functional Collaboration:

• 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.

Vendor and Contract Management:

• 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.

Continuous Improvement:

• Drive process improvements within clinical supply chain management, implementing best practices and leveraging technology to enhance operational efficiency.
• Foster a culture of continuous improvement to optimize supply chain operations and support innovation in clinical trial management.

Qualifications:

• 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.

Skills:

• 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.

Additional Information:

• Occasional travel may be required, both domestic and international.
• Work Environment: Remote Position