Associate Director, Clinical Supply

Wave Life Sciences • Lexington, MA

2d

About The Position

As the Associate Director, Clinical Supply, reporting to the Director, Clinical Supply, this role is responsible for the strategic planning, execution, and oversight of end-to-end clinical trial material across Wave clinical studies. This role leads clinical trial material (CTM) and ancillary supply strategy from study start-up through close-out, ensuring compliant packaging, labeling, distribution, resupply, returns, reconciliation, and destruction. The Associate Director provides cross-functional leadership and vendor oversight (e.g., Randomization and Trial Supply Management (RTSM) and drug distribution partners) to proactively manage supply risk, maintain inspection readiness, and ensure uninterrupted site supply to support patient dosing.

Requirements

• B.S. in a scientific, healthcare, or related field (advanced degree preferred)
• 8+ years of relevant experience in clinical supplies within pharmaceutical/biotechnology and/or CRO environments, including global trial support
• Demonstrated experience leading end-to-end CTM supply strategy and execution (forecasting, demand/supply planning, resupply, returns, reconciliation, and destruction)
• Proven ability to select, set up, and manage vendors (RTSM, Service Providers for P&L) including scope, quality, performance, and budget oversight
• Working knowledge of GxP expectations applicable to clinical supplies, including documentation practices supporting inspection readiness
• Experience with clinical packaging and labeling operations, including label content development, review/approval processes, and management of label changes
• Strong cross-functional leadership skills with experience partnering with Clinical Operations, CMC, Quality, Regulatory, and external sites to resolve issues and drive on-time trial execution
• Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships, including vendors, CROs, etc.
• Ability to work independently and as part of a team in a fast-paced environment
• Demonstrated ability to juggle multiple competing tasks and demands
• Strong attention to detail

Responsibilities

• Partner with Supply Chain and Clinical Operations to plan and ensure on-time availability of Clinical Trial Material (CTM) including Drug Product, placebo, and sourced comparators drugs to support study start-up, enrollment, and ongoing patient dosing
• Source, qualify, and manage ancillary supplies required for CTM preparation, administration, and delivery, ensuring alignment with protocol and country requirements, where applicable
• Author, maintain, and manage approvals for Pharmacy Manuals
• Manage and ensure the integrity of the cold chain for temperature sensitive products
• Select, onboard, and oversee RTSM and other Service Providers (e.g., CMOs, depots, comparator sourcing), including scope definition, governance, performance monitoring, issue management, and budget oversight
• Manage RTSM systems, lead the development of user requirement specifications, lead the development of the User Acceptance Testing (UAT), and provide ongoing oversight of the system’s drug supply management modules
• Lead CTM label strategy and development, including label text creation, review/approval workflows, and vendor execution oversight
• Ensure continuous CTM and ancillary supply availability at investigator sites through robust demand planning, resupply management, inventory oversight, and proactive risk mitigation
• Serve as the Clinical Supply subject matter expert during audits and regulatory inspections; support preparation of responses and ensure clinical supply documentation is inspection-ready
• Develop and maintain study-level supply plans, forecasts, and key performance metrics; provide clear communication of supply status, risks, and mitigations to stakeholders
• Identify and implement process improvements to enhance reliability, compliance, and efficiency of clinical supply operations across programs

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances
• generous paid time off (including a week-long company shutdown in the Summer and the Winter)
• 401K participation with matching contributions
• Employee Stock Purchase Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level