Job Type

Full-time

Description

This is an exciting opportunity for a highly motivated Executive Director, Clinical Supply Chain with extensive leadership experience in global clinical supply chain management. We are looking for a strategic and visionary leader who thrives in a collaborative, fast-paced, and growing environment to head our Clinical Supply Chain team, reporting directly to the Head of CMC. As the senior leader of this function, you will build and manage a high-performing team, oversee end-to-end clinical supply chain programs, and drive operational excellence to support our oncology pipeline.

Responsibilities:

1. Clinical Supply Chain Strategy & Management:

• 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.

2. Inventory Management & Forecasting:

• 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.

3. Regulatory Compliance & Quality Assurance:

• 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.

4. Stakeholder Communication & Cross-functional Collaboration:

• 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.

5. Vendor and Contract Management:

• 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.

6. Continuous Improvement and Team Leadership:

• 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.

Requirements

Qualifications:

• Bachelor's degree in Supply Chain Management, Life Sciences, or related field (Master's or advanced degree preferred).

• Minimum of 15 years of experience in clinical supply chain management or a related field, with 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.

Skills:

• 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.

Additional Information:

• Occasional travel may be required, both domestic and international.

• Work Environment: Remote Position

Salary

The annual salary range for this position is in the San Francisco Bay Area. BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role.

Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.