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 preclinical program in obesity. 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:

The Director of Clinical Supply supports all aspects related to Investigational Product and ancillary supplies for global clinical trials. This position is responsible for managing IVR/IRT and drug distribution vendors for clinical trials including packaging, labeling, distribution, return, reconciliation, and destruction activities. This role is responsible for the development of the Pharmacy Manual and labels for clinical trial materials, sourcing appropriate ancillary products required for the delivery of IMP globally, vetting site pharmacy SOP’s when required, and ensuring IMP is available at sites for dosing of patients during the clinical trials.

Experience:

• B.S. in a scientific, healthcare or related field 
• A minimum of 12-15 years of relevant experience in Pharmaceutical, Biotech or CRO company 
• In-depth knowledge of Pharmacy requirements for clinical trials, including applicable regulatory requirements globally
• Strong knowledge of global IMP shipment requirements including Import licenses, proforma invoices and local/regional depots
• In depth knowledge of the role of IVR/IRT vendors and drug distribution vendors as well as IMP shipment couriers

Responsibilities:    

• Working with CMC to ensure timely availability of required IMP for all clinical trials
• Undertake vendor selection of service providers required for the management and shipment of IMP for all Wave clinical trials including depots, drug distribution vendors and IVR/IRT vendors
• Lead the build of selected IRT systems with the selected vendor 
• Manage and oversee the performance of Clinical Supply Vendors (e.g. Drug Distribution, IRT) including set-up of contracts and change orders, and setting and tracking of Key Performance Indicators
• Manage Clinical Supply Vendor budgets including forecasting of predicted spend, review, and approval of invoices against contract
• Source all ancillary supplies required for delivery of IMP as well as the use of the IMP at site
• Ensure all testing of supplies is conducted in a timely manner 
• Development of the Pharmacy Manual and related documents e.g. prescription templates, drug accountability templates, etc.
• Actively driving process improvement initiatives for clinical supplies and drafting process to ensure optimal management of supply of IMP to all sites (global) e.g., SOPs, processes and plans outlining shipment requirements across regions 
• IMP label development 
• Identify requirements for site pharmacies, and vetting pharmacies as required to support the clinical trials 
• Work with the Regulatory Affairs, Clinical Operations, CMC and other stakeholders to manage Green Light process for drug release
• TMF management for own sections
• Participate in SMT and other meetings and proactively sharing, managing, and mitigating risk related to the management of IMP
• Supporting the preparation of, participating in and presenting at Investigator meetings (virtual or face to face) as required.
• Prepare for and participate in vendor governance meetings
• Manage, mentor, and coach direct reports
• Oversee availability of IMP and related products at sites throughout the trials 
• Manage temperature excursions 
• Act as Subject Matter Expert (SME) during regulatory inspections 
• Collaborate with key stakeholders on SOP development

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 
• Excellent organizational skills
• Problem solving skills
• Demonstrated ability to manage multiple competing tasks and demands
• Strong a