Director, Clinical Supply

The Director of Clinical Supply will lead the strategic and operational oversight of investigational product supply across a development portfolio, mainly consisting of small molecules and radiopharmaceutical therapies.
This individual will design and implement an integrated demand forecasting and clinical supply planning process, ensuring uninterrupted supply of clinical materials for global trials while maintaining full compliance with GMP, GCP, and radiation safety regulations.

The Director will build and lead a lean, high-performing team and partner closely with CMC, Clinical Operations, Quality, Regulatory, and external CDMO & CRO partners to ensure supply readiness, scalability, and efficiency throughout the product development lifecycle.

1. Strategic & Functional Leadership

• Establish and lead the company’s Clinical Supply function, defining the business processes, tools, and governance for forecasting, planning, and inventory control.
• Develop and maintain end-to-end clinical supply strategies for each program, integrating manufacturing, packaging, and logistics considerations for multiple modalities—including time-sensitive radiopharmaceutical products.
• Build and mentor an agile team to deliver operational excellence and cross-functional collaboration.
• Serve as the internal subject-matter expert for clinical supply planning and distribution, guiding study teams and leadership on supply strategy, risk, and optimization.

2. Demand Forecasting & Supply Planning

• In collaboration with Clinical Ops team, design and implement a forecasting model that integrates clinical enrollment projections, protocol amendments, and manufacturing lead times.
• Manage material allocation and supply chain scenarios, ensuring readiness for varying trial demands and minimizing waste for short-shelf-life or radioactive products.
• Maintain visibility of investigational product inventory across depots and sites, optimizing stock levels while ensuring regulatory and safety compliance.

3. Cross-Functional Collaboration

• Partner with CMC group to align manufacturing schedules, batch planning, and packaging timelines with study requirements.
• Collaborate with Clinical Operations to translate enrollment forecasts and site activation plans into actionable supply plans.
• Work closely with Quality Assurance and Regulatory Affairs to ensure compliance with GMP/GCP, import/export, and radiation transport regulations.
• Engage external CDMOs and logistics providers to coordinate production, labeling, and distribution activities, including specialized handling for radiolabeled materials.

4. Process & System Development

• Establish and continuously improve clinical supply planning processes and tools, balancing scalability with flexibility.
• Support implementation of systems (e.g., ERP, IRT/RTSM, or planning dashboards) to enhance transparency and decision-making.
• Develop KPIs to monitor forecast accuracy, supply reliability, and inventory performance across programs.

5. Risk & Compliance Management

• Conduct proactive supply risk assessments and develop mitigation plans for supply interruptions, regulatory delays, or radioactive isotope shortages.
• Ensure compliance with all relevant GMP, GCP and radiation safety standards for material handling, packaging, and transport.
• Support audit readiness and contribute to regulatory filings describing clinical supply strategies and controls.

• Education: Bachelor’s degree in Supply Chain Management, Chemistry, Engineering, or related scientific discipline; advanced degree (e.g. MBA) is preferred.
• Experience:
• 12+ years of experience in clinical supply chain management, preferably within the biotech or pharmaceutical industry.
• Proven track record establishing or scaling clinical supply planning and forecasting processes.
• Experience managing complex supply chains involving multiple modalities—radiopharmaceuticals strongly preferred.
• Direct experience working with CMC and Clinical Operations teams in an integrated development environment.
• Familiarity with GMP/GCP.
• Technical Skills: Working knowledge of ERP, IRT/RTSM, or forecasting software; proficiency in Excel and data analytics.
• Soft Skills: Excellent leadership, communication, and stakeholder management abilities; capable of influencing across functions and levels.

• Key Competencies:

  • Strategic and hands-on execution mindset suited to a mid-size, fast-growing organization.
  • Strong analytical thinking and problem-solving orientation.
  • Ability to navigate complexity and ambiguity across modalities.
  • Commitment to compliance, safety, and operational excellence.
  • Leadership that fosters collaboration, accountability, and growth.