Associate Director, Clinical Supply Chain

Role Summary:

We are seeking an experienced Associate Director, Clinical Supply Chain, to independently lead end-to-end supply for assigned global studies. This hands-on individual contributor will manage clinical demand and supply planning and execution. Global distribution will be a key focus, including country readiness, import and export execution, shipment tracking and issue resolution. 

Working with a high degree of autonomy, this individual will influence cross-functional teams and partner closely with CMC, Clinical Operations, Quality, Regulatory, CROs, CDMOs, and other external providers to ensure uninterrupted, compliant, and cost-effective clinical supply. 

Key Responsibilities:

Supply Chain Planning

• Develop and maintain demand forecasts, supply plans, and scenario models using enrollment, dosing, randomization, manufacturing lead times, expiry, and inventory assumptions
• Monitor inventory, expiry, and resupply across multiple depots and sites; evaluate changes and implement mitigation plans that balance supply continuity, cost, and inventory exposure
• Support sourcing of comparator product and ancillary supplies, as required

Supply Chain Execution

• Develop and maintain the clinical supply strategy for IRT systems, including user requirements, user acceptance testing, configuration review, and optimization of supply settings
• Support review and approval of clinical supply documents, including label text, packaging specifications and batch records, pharmacy manuals, and applicable protocol, IND, and IMPD content
• Collaborate with partners to establish packaging/labeling schedules to ensure continuous availability of clinical supplies

Global Distribution

• Oversee external partners in executing global distribution for assigned studies, including depot-network strategy, inventory positioning, shipping lanes, country requirements, and contingency planning
• Drive country activation from a clinical supply perspective and import-license readiness by maintaining country-specific requirements and readiness trackers, closing documentation gaps, and escalating risks before planned shipments
• Review and coordinate import, export and customs documentation with CROs, CDMOs, Regulatory, importers of record, and other partners
• Manage reverse logistics, including returns, reconciliation, recovery, and destruction, in accordance with protocol, quality, and country requirements
• Build and monitor distribution metrics, including on-time delivery and right first time; use trends to improve processes and partner performance

Cross-Functional Leadership

• Represent Clinical Supply Chain on study and program teams; lead supply discussions and communicate status, risks, tradeoffs, and recommendations to senior leaders and external partners
• Establish scalable processes, templates, governance, and performance standards, and lead continuous improvement across clinical supply operations.

General Project Management

• Maintain budget trackers, inventory and expiry dashboards, supply-risk reporting, KPIs, and vendor-performance metrics
• Forecast costs, monitor budget versus actual spend, review proposals, change orders, and invoices, and identify cost risks and savings opportunities
• Perform other duties as assigned

Ideal Candidate:

• Bachelor’s degree in life sciences, supply chain, business, engineering, or a related field; an advanced degree is preferred
• 6-8+ years of progressive clinical supply chain and logistics experience, including at least 5 years directly managing global clinical supply
• Demonstrated independent ownership of complex blinded global Phase 2 or Phase 3 studies involving multiple product presentations, and/or combination products and devices
• Demonstrated hands-on ownership of global clinical trial distribution across multiple regions, including country activation, import-license readiness, import and export documentation, customs clearance, shipment execution
• Advanced Excel skills and hands-on experience with clinical supply forecasting and optimization platforms (e.g. ERP) and IRT systems
• Working knowledge of GMP, GDP, GCP, global import and export requirements, and applicable clinical supply regulations
• Strong leadership presence and ability to influence cross-functional teams, senior stakeholders, and external partners without direct authority
• Ability to assume ownership quickly with minimal onboarding and oversight, make risk-based decisions with incomplete information, manage competing priorities, and translate complex data into clear recommendations in a fast-paced environment
• Highly organized and adaptable to change
• Experience in a small biotechnology company, start-up, or similarly lean and rapidly evolving environment preferred

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $ ____ to $____. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.