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.
