Associate Director, Clinical Supply Chain Engineer

Sarepta Therapeutics•Burlington, MA

16h•Hybrid

About The Position

The Associate Director, Clinical Supply Chain Engineer, will play a critical role in ensuring the success of global clinical trials across multiple phases of development. You’ll design and develop a robust clinical supply chain that enables timely, compliant, and efficient delivery of investigational products worldwide. This position requires strong process, development, and project management skills to translate clinical program requirements into robust operations. Additionally, you will work closely with strategic partners and CMOs to execute on agreed upon timelines and plans. The position will also be responsible for managing KPI/dashboards, and for ensuring that issues are escalated and key deliverables are progressed.

Requirements

BS in industrial engineering or equivalent with 10+ years of experience in a Pharmaceutical Operations organization and 3+ years of experience with clinical supply
Certification in Lean, Six Sigma, APICS/ASCM, or related disciplines
Experience with process optimization, data analysis, quality, and efficiency
Familiarity with GMP, GDP, and clinical trial supply requirements in regulated environments.
Experience working with CROs, CMOs and third-party vendors
Proficiency with quality systems including developing policies, SOPs and work instructions
Excellent communication, problem-solving, and cross-functional collaboration skills.
Ability to travel domestically and internationally.

Responsibilities

Participate in Clinical Trial Teams and Transition Teams to gather critical information in order to design, develop, and implement robust clinical drug supply operations.
Analyze and improve end-to-end clinical supply chain processes, including packaging, labeling, distribution, returns, and reconciliation.
Facilitate cross-departmental meetings to ensure alignment, identify dependencies, and resolve integration challenges.
Collaborate with functional leaders to harmonize processes, systems, and documentation for the partnered & acquired assets.
Partner with Manufacturing, Quality, Regulatory, and Clinical Operations to ensure clinical material availability aligns with study timelines and compliance requirements.
Evaluate depot, site, and packaging network flows to optimize inventory positioning and shipment strategies, including temperature-controlled and time-sensitive materials.
Lead continuous improvement initiatives focused on process standardization, error prevention, and operational scalability.
Responsible for process mapping and evaluating capacity planning, workflow design, and continuous improvement utilizing methodologies such as Lean or Six Sigma.
Support investigations, root cause analysis, and corrective/preventive actions related to supply chain deviations or performance gaps.
Manage projects with CMOs