Senior Director, Clinical Supply Chain

Voyager Therapeutics - Lexington, MA

Lexington, MA

Chemical Manufacturing

About the position

The Senior Director will be a key leader within the group with a strong background and expertise and will lead all aspects of clinical supply chain which includes supply planning, operations and logistics support. Primary responsibilities will include establishing and managing end-to-end clinical supply for clinical studies in various phases, leading cross functional teams including clinical development/ operations to set up appropriate governance and processes to manage supply.

Responsibilities

• Responsible for establishing and managing the end-to-end clinical supply for clinical studies/programs in various phases
• Ensure on-time startup of new studies by having supplies available as required and continuous supply of clinical trial material for assigned studies globally
• Design and execute packaging and labelling campaigns including label design, translation, and production
• Review clinical protocols and design appropriate supply chain strategy
• Support the procurement, labeling and distribution of comparators including placebo
• Prepare 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 plan
• Lead the development of a pharmacy manual and any related updates
• 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

Requirements

• Bachelor's degree in business operations, supply chain, engineering, or related field
• Advanced degree in business operations or supply chain is a plus
• 12+ years of relevant supply chain and logistics experience in the biotech/pharmaceutical industry
• Experience with both small and large pharma is a plus
• Experience in protein therapeutics, gene therapy or viral vector space is a plus
• Demonstrated leadership in managing cross-functional teams and stakeholders for effective communication and alignment