The Importance of the Role You'll design and develop a robust clinical supply chain that enables timely, compliant, and efficient delivery of investigational products worldwide.
The Opportunity to Make a Difference The Importance of the Role 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.
The Opportunity to Make a Difference - 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
More about You More about You - 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.
What Now? We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Hybrid
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This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
