Manager, Regulatory Project Management

Title: Manager, Regulatory Project Management

Location: Bedford United States

Job Description:

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 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.

Position Purpose:

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.

Key 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

Required Skills & Experience:

• 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

Location(s):

Stoke is located in Bedford, MA. This position is a hybrid position with an office setting based in Bedford, MA location.

Travel:

This position will require approximately 5% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $136,000 - $159,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).

Culture & Values:

At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.

Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.

Stoke participates in E-Verify.