Associate Director, Clinical Supply Chain Management

Stoke Therapeutics•Bedford, MA

2h•$182,000 - $199,000•Remote

About The Position

The Stoke Therapeutics team is seeking an experienced and driven Associate Director, Clinical Supply Chain to lead the planning, forecasting, and execution of clinical supply strategies that ensure uninterrupted drug availability throughout global clinical trials. This individual partners cross-functionally with Clinical Operations, Quality, Regulatory, Manufacturing, and external vendors to manage demand forecasting, inventory, FG production, distribution, and IRT strategy while ensuring regulatory compliance. The role plays a critical part in managing clinical supply activities from study startup through closeout, including labeling, logistics, ancillary supplies, temperature excursions, and shelf-life management. The ideal candidate possesses strong expertise in clinical supply management, forecasting, inventory planning, IRT systems, and cross-functional collaboration, with excellent communication, organizational, and problem-solving skills. This position will report to the Director of Supply Chain.

Requirements

Bachelors in Life Sciences required, advanced degree preferred.
8+ years in Clinical Supply Management or a related field.
Proven experience supporting clinical trial supply, with a strong understanding of clinical study design, execution, and impact of study drug supply.
Demonstrated knowledge of clinical trial process from study start up through trial completion.
Familiarity with various clinical trial designs (randomized, OLE, continued access) and Supply Chains role in supporting material demands.
Demonstrated experience in inventory management and forecasting drug supply.
Experience with IRT systems and managing the forecasting and planning of drug supply needs.
Strong understanding of GMP and GDP.
Proficient knowledge of Microsoft Excel, PowerPoint and Project software required.
Excellent communication and influencing skills, strong collaboration skills.
Strong attention to detail.
Ability to multi-task and manage complexity.

Responsibilities

Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, and internal milestone timelines to develop forecasts and associated supply/distribution plans based on clinical study protocols.
Monitor inventory levels at depots and clinical sites through the life of a clinical trial.
Ensure regular interaction with cross-functional team members related to changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements.
Generate manufacturing requests, review pre-production and post-production documentation with Quality Assurance to coordinate the timely release of IMP.
Coordinate import and export of materials to support clinical and non-clinical studies.
Support the procurement, labeling, and distribution of ancillary supplies.
Facilitate the development of pharmacy manuals and any related updates
Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design, implementation, and user acceptance testing (UAT) for IRT systems, ensuring effective tracking, randomization, and inventory management.
Responsible for management, compliance, and oversight of relevant eTMF sections.
Support the process for label generation and approvals, including regulatory variations and translation activities.
Manage study closeouts and drug reconciliation at study end
Work closely with Quality Assurance to resolve temperature excursions.
Monitor shelf-life and expiry dating of IMP and coordinate retest extension to ensure continuous supply.