Associate Director, Clinical Supply

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a clinical program in obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

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.

Experience

• 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

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

Key Skills

• 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

Pay Range External Disclosure Statement

The annual base salary range for this position is $158,000 - $215,000.

The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, 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, and Employee Stock Purchase Program.

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.

Salary : $158,000 - $215,000