Senior Manager or Associate Director, Supply Chain

Kymera Therapeutics•Watertown, MA

3d•$145,000 - $240,000

About The Position

We are seeking a Senior Manager/Associate Director of Supply Chain who will be responsible for managing and ensuring timely supply of materials for nonclinical and clinical studies at all stages of development. This role will be responsible for supply planning and execution for assigned projects, including demand forecasting, management of supply chain vendors, inventory management at depots and sites, packaging and labeling, import and export of drug substance and drug product, returns and destruction. The successful candidate can execute independently to ensure reliable supply for Kymera’s portfolio while also bringing the experience and judgment to help shape strategy, identify risks, and improve systems/processes as we scale. This position reports to the Director, Supply Chain.

Requirements

BA/BS in Supply Chain/Operations or life sciences/health-related field.
8+ years of experience in clinical supply chain management in the pharmaceutical industry, including global clinical trial supply operations
Experience managing contract organizations for clinical labeling, packaging and distribution; ability to drive accountability through clear scope, timelines, and KPI’s
Experience with clinical blinding practices and implementation/operation of IRT systems
Knowledge of global and regional regulations pertaining to labeling and packaging, cGMP requirements and good distribution practices
Working knowledge of import and export requirements, including proficiency in document preparation and international shipping logistics
Ability to support, as needed, the investigation and resolution of complaints, product rejections, non-conformances, recalls, deviations, and trends from process performance
Strong communication and stakeholder management skills; ability to work in a fast-paced environment while handling multiple priorities

Responsibilities

Lead packaging, labeling, and distribution of clinical supplies from study initiation through closeout
Develop and maintain clinical supply plans (forecast, timelines, and supply scenarios) in coordination with CMC and Clinical functions
Coordinate and manage distribution of clinical trial material to depots and sites for clinical studies; monitor supply status and proactively mitigate risk.
Manage clinical packaging/distribution vendors, including day-to-day oversight, issue resolution, review of batch documentation, and performance management (as applicable: support vendor selection and contract negotiations).
Participate in the setup, testing and operation of interactive supply tracking systems (IRT) and other clinical supply tracking tools; ensure data accuracy and operational readiness.
Represent the Supply Chain function on CMC and Clinical Study Teams and serve as the interface between the CMC and clinical teams to ensure smooth conduct of clinical studies.
Coordinate import and export of materials to support clinical and non-clinical studies
Materials management for GLP toxicology and clinical materials, including maintenance of inventory database and GxP documentation related to material receipt, storage and distribution
Ensure compliance with industry standards, GMP, GDP, and applicable state and federal regulatory requirements; support audits/inspections as needed.
Drive continuous improvement by standardizing processes, templates and metrics to improve visibility, cycle time, and reliability.