Job description

Manager, Clinical Supply Chain Management
Reporting to the Director, Clinical Supply Chain the Manager, Clinical Supply Chain Management will be responsible for establishing and managing the end to end clinical supply for clinical studies/programs in various phases. Successful candidates will possess a fun, flexible, roll up your sleeves attitude, have the ability to work independently and enjoy working in a dynamic, fast-paced environment.
This is an office-based role and will based in one of our offices located in Lexington, MA. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Ensure continuous supply of clinical trial material for assigned studies globally
Ensure on-time startup of new studies by having supplies available as required
Manage clinical packaging and distribution vendors
Design and execute packaging and labelling campaigns
Support the procurement, labeling and distribution of comparators
Review clinical protocols and design appropriate supply chain strategy
Work collaboratively with Clinical Operations, Quality Assurance and Regulatory Affairs
Interpretation of a protocol or study overview to calculate total demand and forecast over time
Managing clinical labeling including label design, translation, and production
Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams
Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies globally
Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors
Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
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 & UAT testing
Manage study closeouts and drug reconciliation at study end
Ensure all clinical supply related documents are filed in the eTMF
Develop and manage clinical supply budget for assigned studies
Oversee Clinical Supply Chain timelines to ensure on-time completion of deliverables
Qualifications:
Requires a BS degree with 3+ years’ experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment
Experience managing contract packaging and labeling organizations
Experience with developing risk-based supply strategy for an early to late-stage clinical development programs
Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
Global distribution experience including working with QP, IRT and regional depots.
Excellent project management and communication skills
Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient