Senior Manager, Clinical Supplies - Global Trials

Xenon Pharmaceuticals; Needham (MA); Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical benefits

Stock options

Tuition Assistance

Job summary

Xenon Pharmaceuticals is seeking a Manager/Senior Manager, Clinical Supplies to ensure timely provision of labeled clinical supplies to sites, in line with trial protocols and regulatory requirements.

The role collaborates with CMC, Supply Chain, Clinical Operations, Regulatory Affairs and Quality Assurance, reporting to the Senior Director, Clinical Supplies. Based in Boston/Needham with hybrid onsite expectations.

Qualifications

• Minimum 7+ years in pharmaceutical/biotech with 5+ years international clinical supply experience.
• Thorough knowledge of GMP, GCP, GDP and ICH guidelines.
• Experience with IXRS design, implementation, UAT and monitoring.
• Proficiency with Microsoft applications and EDC systems.
• Excellent written and oral communication skills and attention to detail.

Responsibilities

• Develop study-specific Investigational Product Supply Plans and contribute to Pharmacy Manuals and supply-related materials.
• Manage supply planning/forecasting to align with study activity and timelines.
• Track supply accountability and ensure Master, Pharmacy and Subject logs are correct in the Trial Master File.
• Monitor inventory levels at sites to proactively avoid issues.
• Coordinate procurement, temperature control, and product complaints; manage expiry extensions.
• Liaise with packaging, distribution, and storage vendors; assist in budgeting and tracking.
• Design and approve investigational supply label text to meet country requirements.
• Ensure adequate releases per regulations and ensure QA documentation.

Skills

GMP knowledge

GCP knowledge

GDP knowledge

ICH guidelines

IXRS design

Inventory management

Attention to detail

Strong communication

Education

Bachelor’s degree in health sciences or life sciences

Tools

IXRS

Inventory management systems

Electronic data capture (EDC) systems

Job description

Xenon Pharmaceuticals is seeking a Manager/Senior Manager, Clinical Supplies to ensure timely provision of labeled clinical supplies to sites, in line with trial protocols and regulatory requirements.

The role collaborates with CMC, Supply Chain, Clinical Operations, Regulatory Affairs and Quality Assurance, reporting to the Senior Director, Clinical Supplies. Based in Boston/Needham with hybrid onsite expectations.