About Stoke

Stoke Therapeutics (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 Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/

Position Purpose

The Sr. Director, Quality Control, will be responsible for providing strategic, scientific, and operational leadership for the QC function at Stoke. This person is accountable for the end-to-end QC strategy, including analytical control and stability strategy, oversight of external QC operations, and regulatory readiness for early clinical development through late-stage development and commercialization. This person is expected to influence Stoke’s quality culture to help reach a sustained state of inspection readiness for all QC related activities. This person will support the development and execution of Stoke’s GMP Quality Management Plan for compliance and risk monitoring for all analytical activities related to Stoke products. This person will be required to contribute to maintaining a fit for purpose and scalable Quality Management System that is always ready for inspection.

The ideal candidate is a seasoned QC leader with expertise in analytical method lifecycle management, can demonstrate the ability to successfully work with CMOs and CTLs, and a proven ability to build scalable, phase appropriate processes in a lean environment. This person must have a strong working knowledge of relevant FDA, EU, ICH GMP guidelines and regulations for phase appropriate application for product development. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for product development and quality management is essential to this role. The candidate should be willing to roll up their sleeves and directly contribute to the implementation of processes, technical aspects of development and resolution of issues as required. This role will report into The VP of Quality and will partner closely with other cross-functional groups such as CMC Analytical Development, CMC Manufacturing, Regulatory and other functions within Quality.

Key Responsibilities

Aligned with CMC, establish and lead Stoke’s global QC strategy for all stages of product development.
Act as a QC subject matter expert and thought partner to senior leadership.
Establish and maintain a phase appropriate analytical control strategy to support clinical development, global regulatory filings, and commercialization.
Oversee the lifecycle management of analytical methods for oligonucleotide products, including method transfer, qualification, validation, optimization, stability testing, specification justification and maintenance, shelf-life management, reference standard management and remediation.
Lead the QC group responsible for routine GMP in-process, release, and stability testing, and establish the long-term quality control testing strategy for clinical and commercial programs.
Lead selection, governance, and performance management of CTLs, ensuring excellence with respect to technical support, compliance, and consistent delivery.
Partner with CMC, QA, Regulatory Affairs and Program Teams to ensure QC strategies support overall control strategy.
Provide leadership and technical input into CMC and analytical sections of regulatory submissions (IND, NDA, IMPD, MAA).