Director, Clinical Supply Chain- CMC

Iambic Therapeutics, Inc•San Diego, CA

About The Position

Iambic Therapeutics is seeking a Director of Clinical Supply Chain within CMC function to lead end-to-end clinical supply strategy and execution for small molecule programs from first-in-human through clinical phases. This role will develop and execute integrated supply plans, oversee packaging/labeling and global distribution, and ensure uninterrupted investigational product supply to clinical sites while minimizing waste and controlling cost. The successful candidate will partner closely with Clinical Operations, Regulatory, Quality, Project Management, and CMC technical teams to align forecasts and manufacturing schedules, manage vendor performance, maintain inspection-ready documentation, and establish fit-for-purpose IRT/RTSM requirements to enable reliable, patient-ready clinical supply execution. Preferred location is in San Diego, CA

Requirements

Bachelor’s degree in a life science, engineering, or business-related discipline with 15+ years of clinical supply chain and logistics experience or advanced degree in a life science, engineering, or business-related discipline with 12+ years of experience.
Direct experience leading clinical supply chain operations across Phase 1–3, including forecasting, inventory strategy, packaging/labeling oversight, depot operations, and global distribution.
Demonstrated experience managing logistics flows for GMP materials (API and drug product) across CDMOs, testing sites, depots/3PLs, and clinical sites, including import/export and temperature-controlled shipping where applicable.
Experience defining and/or partnering on IRT/RTSM requirements and supporting system build, UAT, go-live, and lifecycle change control.
Demonstrated ability to translate protocol assumptions into supply logic and resupply strategies.
Strong vendor oversight and contract/SOW management skills, with a track record of driving performance, resolving issues, and controlling cost in a fast-paced environment.
Working knowledge of GCP/GMP/GDP expectations applicable to clinical supply, including inspection readiness, documentation practices, and quality event management.
Excellent written and verbal communication skills, including ability to present inventory status, risks, and mitigation plans to stakeholders.
Ability to travel up to 20% domestically and internationally, as needed

Responsibilities

Serve as the clinical supply chain lead in a cross-functional matrix team, defining and driving execution of clinical supply strategies aligned with protocol requirements and program timelines.
Develop and maintain integrated demand forecasts, enrollment scenarios, and inventory/resupply strategies to ensure uninterrupted IP/IMP supply to depots and clinical sites while minimizing waste and write-offs.
Plan and oversee packaging and labeling operations with CPO partners, including label content coordination and cross-functional review/approval workflows in alignment with regulatory requirements.
Own logistics strategy across the networks (DS/DP CDMOs, packaging/labeling sites, depots, and global clinical sites), including shipment execution and import/export coordination.
Oversee depot operations including inventory oversight, drug accountability, returns, reconciliation, and destruction.
Provide strategic direction for clinical supply planning to establish IRT/RTSM requirements and specifications.
Manage third-party vendors (CDMOs, CPOs, depots/3PLs, couriers, IRT vendor) including scope, performance, KPIs/QBRs, issue resolution, and cost control.
Partner with Quality Assurance on quality events and investigations impacting clinical supply (deviations/CAPA, batch record review, disposition).
Contribute to the preparation, review, and approval of operational clinical supply documents (e.g., packaging batch records, pharmacy manuals, shipment plans, accountability/reconciliation documentation).
Track clinical supply budgets and analyze spend against projections to support accurate financial forecasting and ensure operations remain within targets.