Clinical Supply Chain

Associate Director/Director, Clinical Supply Chain

Location: In-person– San Diego, CA

Employment Type: Full‑time

Reports to: Head of CMC

About the Role

The Associate Director/Director, Clinical Supply Chain provides strategic leadership and oversight for global clinical supply chain operations across the company's clinical development portfolio. This role is accountable for developing and executing end-to-end clinical supply strategies that enable the successful advancement of products from First-in-Human through Late-stage clinical development.

As a key leader within Technical Operations Department, the cross-functional interface with Quality, Process Development, Manufacturing, Finance, and Clinical Development to maintain uninterrupted, compliant, and cost-effective supply of investigational products worldwide. The role is responsible for day-to-day oversight of clinical supply, program level planning, logistics, customs, and supplier management. Will provide insights into vendor network strategy, operational risk management, and organizational capability development to support both current programs and future growth.

The successful candidate will bring deep expertise in all aspects of clinical supply chain execution, strong interpersonal skills, and the ability to lead through ambiguity while building scalable processes and high-performing teams in a dynamic biotech environment.

Key Responsibilities

Strategic Leadership & Portfolio Management

• Develop and execute a global clinical supply chain strategy across a portfolio of clinical programs, ensuring alignment with corporate development objectives and program timelines.
• Serve as the clinical supply chain leader on cross-functional development teams, influencing study design, development strategies, manufacturing planning, and operational execution.
• Establish portfolio-level supply planning frameworks, capacity models, and risk management strategies to support growing clinical operations.
• Influence executive-level decision-making regarding supply continuity, inventory optimization, expiry planning, and investment priorities.
• Provide strategic direction for clinical supply governance, establishing key performance indicators, business processes, and organizational standards.

Clinical Supply Planning & Execution

• Direct end-to-end clinical supply activities including demand forecasting, supply planning, packaging, labeling, distribution, returns, reconciliation, destruction, and study closeout.
• Ensure clinical supply readiness for all development milestones, including Labeling, Site Activation, First Patient In (FPI), Last Patient Last Visit (LPLV), and regulatory submissions.
• Oversee forecasting methodologies and inventory strategies across multiple studies, countries, and development phases.
• Drive proactive management of product expiry, shelf-life extensions, comparability transitions, pooling strategies, and supply continuity planning.
• Lead supply scenario analyses and contingency planning to support rapidly evolving clinical development needs.

Vendor & External Partner Leadership

• Develop and manage strategic relationships with clinical packaging organizations, depot providers, logistics partners, CROs, and IRT vendors.
• Establish vendor governance programs, performance metrics, service-level agreements, and continuous improvement initiatives.
• Lead contract strategy, scope management, and budget negotiations to maximize operational performance and financial efficiency.
• Serve as the executive escalation point for critical supply chain issues affecting development timelines or patient enrollment.

Clinical Supply Systems & Technology

• Provide strategic oversight of IRT design, implementation, validation, and lifecycle management.
• Champion digital transformation initiatives that improve supply planning, inventory visibility, forecasting accuracy, and operational scalability.
• Inform on implementation and optimization of supply chain technologies, ERP systems, reporting tools, and analytics platforms.
• Establish data governance standards and ensure accurate inventory visibility across bulk, intermediate, and finished clinical supplies.

Quality, Compliance & Inspection Readiness

• Ensure global clinical supply activities comply with applicable GMP, GCP, ICH, regulatory, and regional import/export requirements.
• Maintain inspection-ready documentation and oversight practices to support audits, regulatory inspections, and due diligence activities.
• Partner with Quality and Regulatory Affairs to ensure compliant labeling, distribution, storage, and product accountability processes.
• Lead investigations, root cause analyses, CAPAs, and risk mitigation activities associated with clinical supply operations.

Financial & Business Management

• Develop and manage clinical supply chain budgets across the development portfolio.
• Partner on cost optimization initiatives through improved forecasting accuracy, inventory management, vendor performance, and supply chain efficiencies.
• Provide executive leadership with meaningful business insights, performance metrics, and strategic recommendations.
• Support diligence activities, portfolio planning, and long-range business forecasting as the organization grows.

Organizational Leadership

• Build, mentor, and develop a high-performing clinical supply chain team.
• Establish organizational priorities, resource planning, and succession strategies to support future growth.
• Foster a culture of accountability, innovation, collaboration, and continuous improvement.
• Serve as a recognized subject matter expert and thought leader in clinical supply chain management across the organization.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 15+ years of clinical supply experience in biotech/pharma, with 10+ years leading global Phase II/III studies.
• Proven experience engaging with CROs and complex vendor ecosystems.
• Experience with global regulatory requirements, ICH‑GCP, and operational best practices.
• Demonstrated ability to lead cross‑functional teams and drive decision‑making in ambiguous, fast‑moving environments.
• Excellent communication, leadership, and problem‑solving skills.
• Experience with small molecule clinical supply and inflammatory disease preferred but not required.
• Prior small biotech experience strongly preferred.