Manager, Regulatory Project Management

Stoke Therapeutics, Inc.•Bedford, MA

38d•$136,000 - $159,000•Hybrid

About The Position

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 approach, the company 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 entered into a strategic collaboration with Biogen in 2025 to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights STK-002 is Stoke's proprietary antisense oligonucleotide (ASO) in clinical development for the treatment of autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. STK-002 has been granted orphan drug designation by the FDA. A Phase 1 study (OSPREY) of STK-002 in people with ADOA is now underway. The company is also conducting early research in Syngap1, a severe and rare neurodevelopmental disorder, in collaboration with Acadia Pharmaceuticals. Stoke's initial focus is on 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 the Company's proprietary approach. The Manager, Regulatory Project Management, through partnership with the global regulatory leader, has significant responsibility for developing, driving, operationalizing, and executing regulatory program strategy. This individual will serve as the primary point of contact to ensure Regulatory functional plans are aligned with program objectives and commitments. Works closely with the Global Regulatory Leader (GRL) and partners across Regulatory Affairs as well as Project Management, Medical Writing, Clinical and other key functions to ensure confidence, quality, and speed in the delivery of regulatory goals. This position will report to the Chief Regulatory Officer.

Requirements

5+ years pharmaceutical industry experience with prior responsibility for project management in a pharma function
Solid understanding of drug development for pharmaceuticals
Exceptional attention to detail and excellent organization skills
Excellent interpersonal, written, and oral communication skills
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Creative and open-minded

Responsibilities

Partners with the program global regulatory lead (GRL) to ensure global regulatory project plans reflecting the goals of the program team and submission working group (SWG) plans are established and executed upon.
Partnering with the program GRL, co-lead and facilitate regulatory subteam meetings and cross-functional SWG meetings, to oversee, plan and deliver goals in accordance with regulatory strategy.
Prepare and deliver reports and metrics on major regulatory milestone status, potential critical issues, constraints, bottlenecks, regulatory risks and mitigation management for assigned programs.
Collaborate with the submission team members to identify areas of improvement and implement necessary measures, including identifying and proposing solutions for addressing potential systemic bottlenecks and constraints.
Operational support may include, but is not limited to drafting and preparation of forms and cover letters, providing logistical support for regulatory subteams and submission working groups, document reviews, health authority meetings, coordinating roundtable meetings, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.).
Partner with Program Management to develop efficiencies by ensuring consistent approaches and development of best practices across the organization.
Lead or contribute to process improvement or operational excellence initiatives within Regulatory function or Stoke in general, as applicable.
Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards related to regulatory submissions