Director, Clinical Supply Chain (Clinical Supply), Late Stage

Role Overview 

We are seeking a Director of Clinical Supply Chain to lead end-to-end clinical supply execution for a global late-stage clinical trial. This role will have full ownership of clinical supply strategy and execution, from demand forecasting through distribution, for programs involving prefilled syringes (PFS) and autoinjectors. The successful candidate will be comfortable operating within a fast-paced environment and partnering closely with Clinical Operations, Quality, CMC, and external vendors to ensure uninterrupted drug supply for our studies. This is a great opportunity to own a critical late-stage program with real patient impact and to have the ability to shape clinical supply strategy during a pivotal stage of the company’s evolution.

Key Responsibilities 

Clinical Supply Strategy & Execution

• Own the global clinical supply strategy for late-stage programs, including demand forecasting, inventory management, and risk mitigation.
• Develop and maintain integrated supply plans aligned with enrollment forecasts, dosing schedules, and protocol amendments.
• Ensure seamless transition and continuity of drug supply.

Drug Product Development

• Lead clinical supply activities for vials, prefilled syringes (PFS), and autoinjectors, including:
• Device assembly and packaging considerations
• Cold-chain (2–8°C) requirements
• Labeling, blinding, and re-supply strategies
• Partner with CMC and device vendors to support lifecycle changes, comparability, and scale-up impacts to clinical supply.

Vendor & Depot Management

• Manage external partners including:
• Packaging and labeling vendors
• Global depots and regional distribution hubs
• Couriers and specialty logistics providers, as appropriate
• Lead vendor selection, SOWs, budgets, timelines, and performance oversight.
• Ensure qualified shippers, temperature monitoring, excursion management, and deviation handling are done in a compliant manner.

Distribution & Regulatory Compliance

• Oversee global distribution across multiple regions, ensuring:
• Country-specific import/export requirements
• QP release and EU clinical supply compliance where applicable
• Ensure inspection-ready documentation and robust supply chain traceability.

Cross-Functional Leadership

• Serve as the clinical supply chain lead on cross-functional study teams.
• Partner closely with:
• Clinical Operations on enrollment and site strategy
• Quality on GMP/GDP compliance and deviations
• Regulatory and CMC on changes impacting supply
• Communicate risks, mitigations, and trade-offs clearly to senior leadership.

Qualifications 

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience
• 10+ years of experience in clinical supply chain / clinical supply operations.
• Direct experience managing Phase 3 clinical trials, including global distribution.
• Hands-on experience with prefilled syringes (PFS) and/or autoinjectors in a clinical trial setting.
• Demonstrated ownership of:
• Forecasting and supply planning
• Packaging, labeling, and distribution
• Vendor and depot management
• Strong understanding of GMP/GDP, ICH-GCP, and global clinical supply requirements.
• Cold-chain biologics experience (2–8°C).
• Experience transitioning programs toward commercial readiness.
• Demonstrated ability to balance strategy and execution.
• An ownership mindset, ability to anticipate risk and solve problems proactively.
• Clear communication skills and the ability to translate supply complexity into actionable decisions.

Position Location 

This is a remote role; periodic travel to team and company events is required. 

The anticipated salary range for candidates for this role is $210,000 - $235,000. The final salary offered will depend on several factors, which may include, but not limited to, relevant years of experience, educational background, and geography.