Associate Director, Global Supply Chain (CMC)
New
T
Tyra BiosciencesPharmaceutical biotechnology
Remote, USFull-TimeDirector
SalaryBase Salary Range: $188,791 - $205,444 USD
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Job Details
- Experience
- Minimum 8 years of relevant experience in pharmaceutical, biotechnology, or clinical supply operations.
Requirements
- Bachelor’s degree in Supply Chain Operations, Business, Engineering, Life Sciences, Pharmacy, or a related field.
- Minimum 8 years of relevant experience in pharmaceutical, biotechnology, or clinical supply operations.
- Demonstrated experience leading global clinical supply activities for complex studies and development programs.
- Expertise in clinical demand forecasting, inventory planning, supply strategy development, and risk management.
- Hands-on experience with IRT systems, including design, implementation, testing, and study maintenance.
- Experience managing CMOs, clinical depots, logistics providers, packaging vendors, and other external service providers.
- Strong understanding of clinical packaging, labeling, distribution, logistics, inventory management, and reconciliation.
- Working knowledge of global import/export requirements and customs regulations for clinical trials.
- Strong understanding of GxP quality systems and applicable regulatory requirements.
- Working knowledge of drug substance, drug product, stability, packaging, and CMC activities affecting clinical supply strategy.
- Must be able to travel domestically and internationally up to 10%.
Responsibilities
- Lead global clinical supply strategies and execution for assigned clinical programs and studies.
- Translate clinical protocols, enrollment assumptions, country activation plans, dosing regimens, and timelines into demand forecasts and supply plans.
- Develop supply scenarios, risk assessments, inventory strategies, safety stock, resupply, and allocation plans.
- Serve as the clinical supply lead and primary point of accountability for assigned studies and development programs.
- Oversee packaging, labeling, storage, distribution, returns, reconciliation, destruction, and transportation activities.
- Manage IRT strategy, system design, implementation, testing, deployment, maintenance, and study closeout.
- Monitor inventory, expiry, shipment performance, and supply metrics; manage excursions, deviations, discrepancies, and interruptions.
- Ensure compliance with GxP, quality procedures, and regulatory requirements; support audits, inspections, and documentation.
- Coordinate with cross-functional teams and external providers on supply planning, regulatory submissions, and import/export readiness.
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