Senior Manager, Clinical Supply

Role Summary:

The Senior Manager Clinical Supply manages, and monitors activities related to ongoing clinical trial operations and systems to ensure supply continuity. In addition, the role supports readiness of the clinical label and pack set up, global trial distribution network and clinical trial systems for upcoming clinical studies.  

The Senior Manager closely interfaces Clinical Operations, Quality, Product Development, Regulatory Affairs, Contract Manufacturing Organization (CMO), Contract Research Operations (CRO’s) and clinical sites to ensure clinical trial supply material is available as required and readiness of the clinical supply network work support the clinical trial strategy. The clinical supply team also provides critical input to set the clinical trial strategy.  

This is a full-time position based in Waltham, MA 

Primary Responsibilities Include: 

Clinical Trial Supply 

• Oversee clinical supply operations, including labeling, packaging, distribution, and resupply across global depots 
• Manage depot and site inventory in collaboration with Trial Managers; ensure timely IMP and placebo shipments globally 
• Coordinate labeling and packaging activities with Clinical CMOs and monitor international shipping and distribution 
• Manage exceptions in Quality Systems (deviations, investigations, CAPAs, specifications, and change controls) 
• Ensure readiness of labeling, packaging, and distribution networks for future trials 
• Align with Supply Planning on demand forecasts, manufacturing outputs, and supply continuity; reconcile inventory and shipments monthly 
• Lead development and updates of pharmacy manuals for Phase I–III trials; provide input to clinical strategy and study protocols 
• Manage product returns, replacements, and destruction in collaboration with Clinical Operations and Quality 
• Identify and implement process improvements; act as SME during regulatory audits 
• Represent Clinical Supply on global project teams and collaborate cross-functionally to build capabilities 
• Author and maintain SOPs and work instructions for inventory, IRT, labeling, distribution, returns, and destruction 

Network Logistics Support 

• Coordinate shipments between CMOs, warehouses, 3PLs, test labs, and other nodes 
• Support network resupply with internal teams and external partners (couriers, customs brokers, CMOs) 
• Ensure compliant, timely shipments including documentation, booking, tracking, and closure 
• Troubleshoot logistics issues and implement corrective actions 

Education, Experience, and Skills Requirements: 

• BS/BA degree (Masters preferred) in life sciences or business major or equivalent required. 
• 5+ years of related experience in the pharmaceutical or biotech industry with at least 3 years of direct experience in global clinical supply management. 
• Experience leading contract manufacturing is required. 
• Excellent interpersonal and organizational skills. 
• Ability to work and influence across different functions and stakeholders 
• High collaborative team-player who fosters open communication, facilitates mutual understanding, drives alignment and effectively maintains relationships with key internal and external stakeholders. 
• Proven ability to manage external vendors 
• Operational experience managing material movements across global CMOs, 3PLs, warehouses, and Test Labs. 
• Proactive problem solver and self-directed individual with the ability to operate independently in a complex, fast-paced environment. 
• Ability to set clear objectives, effectively plan, prioritize, and anticipate challenges and drive execution per plan.  

 

 

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