Associate Director, Clinical Quality Compliance

<div class="content-intro"><p><strong><u>About Stoke:</u></strong></p> <p>Stoke Therapeutics&nbsp;(Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in&nbsp;Bedford, Massachusetts. For more information, visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.stoketherapeutics.com%2F&amp;esheet=54531662&amp;newsitemid=20260507458327&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.stoketherapeutics.com%2F&amp;index=10&amp;md5=10ebc704bd2cecf44bfb9eaaa83a686c">https://www.stoketherapeutics.com/</a></p></div><p><strong><u>Position Purpose:</u></strong></p> <p>The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This role will report into The VP of Quality and will interface closely with other cross-functional groups such as Clinical Development, Clinical Development Operations, DMPK, Regulatory and other functions within Quality.</p> <p>This person will support Stoke’s clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all Stoke clinical and bioanalytical studies. This person will be responsible for establishing Stokes inspections management program for GCP inspections and expected to be influential towards maturing Stoke’s quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute Stoke’s Clinical Quality Management Plan for compliance and risk monitoring for all Stoke clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.</p> <p><strong><u>Key Responsibilities:</u></strong></p> <